CancerPhase 2DRUPNCT02925234
The Drug Rediscovery Protocol (DRUP Trial)
A Phase 2 study testing Panitumumab, Olaparib and Dabrafenib in people with Cancer and Tumors, run by The Netherlands Cancer Institute at 36 sites in Netherlands.
Trial summary
This is a prospective, non-randomized clinical trial that aims to describe the efficacy and toxicity of commercially available, targeted anticancer drugs* prescribed for treatment of patients with advanced cancer with a potentially actionable variant as revealed by a genomic or protein expression test. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Panitumumab, Olaparib and Dabrafenib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,550 participants
- Where
- 36 sitesNetherlands
- Study dates
- Aug 2016to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (age >18 years) patient with a histologically-proven locally advanced or metastatic solid tumor, multiple myeloma or B cell non-Hodgkin lymphomawith symptomatic disease progression or progression according to RECIST-criteria after standard anti-cancer treatment or for whom no such treatment is available or indicated.
- For patients with a primary brain tumor: Histologically confirmed recurrent or de novo primary brain tumor, with unequivocal progression after prior therapy, at least 3 months after radiotherapy (either first line chemo-radiotherapy or re-irradiation), and with stable or decreasing dosage of steroids for at least 7 days prior to the baseline MRI scan.
- ECOG performance status 0-2
- Patients must have acceptable organ function as defined below. However, specific inclusion/exclusion criteria specified in the drug-specific study manual will take precedence:
- Absolute neutrophil count ≥ 1.5 x 109/l
- Hemoglobin > 5.6 mmol/l
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- Platelets > 75 x 109/l
- Total bilirubin < 2 x ULN
- AST (SGOT) and ALT (SGPT) < 2.5 x institutional ULN (or < 5 x ULN in patients with known hepatic metastases)
- Serum creatinine ≤ 1.5 × ULN or calculated or measured creatinine clearance ≥ 50 mL/min/1.73 m2
- Patients must have objectively measurable disease (by physical or radiographic examination, according to RECIST v1.1 for patients with solid tumors, or according to IMWG, Lugano, RANO or GCIG criteria, resp., for patients with multiple myeloma, non-Hodgkin lymphoma, glioblastoma or ovarian cancer in case of CA125-based evaluation (please refer to appendices for further details).
- Results must be available from a tumor genomic or protein expression test. Eligible tests may include any of the following technologies: fluorescence in situ hybridization (FISH), polymerase chain reaction (PCR), comparative genomic hybridization (CGH), next generation sequencing (NGS) or immunohistochemistry (IHC). The test may have been performed on the primary tumor or a metastatic deposit, in a diagnostic laboratory or within the context of another CPCT study, and must reveal a potentially actionable variant as defined in Section 5. The test results (full pathology or molecular diagnostics report) must be uploaded in the eCRF.
- Patients must have a tumor profile for which treatment with one of the FDA and / or EMA approved (or under revision for approval) targeted anti-cancer drugs included in this study has potential clinical benefit based on preclinical data or clinical information (see section 5).
- new (obtained ≤2 months before inclusion, and without any type of anti-cancer therapy within those ≤2 months) fresh frozen tumor biopsy specimen for extensive biomarker testing is mandatory before the start of treatment with a targeted agent included in the protocol. Alternatively, fresh frozen tumor tissue acquired in the context of a standard care procedure may be used, provided that no systemic anti-cancer treatment was given between the procedure and start of study treatment within DRUP.
- The following exceptions are made:
- An exception is made for patients with a primary brain tumor, only if the mandatory DRUP pre-treatment biopsy for biomarker analysis cannot safely be obtained:
- The fresh frozen tumor biopsy sample may be replaced by fresh frozen tumor tissue, obtained earlier from recurrent disease, as part of standard of care surgical procedure (i.e., performed at progression)
- If no fresh frozen tumor tissue is available for NGS, and the risk of obtaining a new tumor biopsy is considered too high, no biopsy will be required. In this case, the study coordinators must be informed in advance, and there will be no reimbursement for the biopsy procedure.
- In case WGS is performed on tumor tissue outside the context of a clinical trial before inclusion, and without any type of anti-cancer therapy between the collection of tissue and inclusion in DRUP, this can replace the DRUP pre-treatment biopsy, provided that the patient gives consent to use his/her WGS data for biomarker analysis in DRUP.
- An exception is made for patients that underwent an allogeneic hematopoietic stem cell transplantation prior to study enrollment, since this will prevent a correct WGS analysis due to a mismatch between the biopsy specimen and the required blood sample.
- Ability to understand and the willingness to sign a written informed consent document.
- For orally administered drugs, the patient must be able to swallow and tolerate oral medication and must have no known malabsorption syndrome.
- Because of the risks of drug treatment to the developing foetus, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation, and for four months following completion of study therapy. Male patients should avoid impregnating a female partner. Male patients, even if surgically sterilized, (i.e. post-vasectomy) must agree to one of the following: practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or completely abstain from sexual intercourse.
Who cannot join
- Ongoing toxicity > grade 2, other than alopecia.
- Patient is receiving any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement). Required wash out period prior to starting study treatment is at least two weeks. An exception is made for:
- Patients suffering from CRPC are allowed to continue androgen deprivation therapy.
- Medications that are prescribed for supportive care but may potentially have an anti-cancer effect (e.g., megestrol acetate, bisphosphonates). These medications must have been started ≥ 1 week prior to enrollment on this study.
- Patient is pregnant or nursing.
- Patients with known active progressive brain metastases. Patients with previously treated brain metastases are eligible, provided that the patient has not experienced a seizure or had a clinically significant change in neurological status within the 3 months prior to registration. All patients with previously treated brain metastases must be stable for at least 1 month after completion of treatment and off steroid treatment prior to study enrollment.
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- Additional exclusion criteria specific for glioblastoma patients:
- Patients who require anti-convulsant therapy must be taking non-enzyme inducing antiepileptic drugs (non-EIAED). EIAED are prohibited. Patients previously on EIAED must be switched to non-EIAED at least 2 weeks prior to randomization.
- No radiotherapy within the three months prior to the diagnosis of progression.
- No radiotherapy with a dose over 65 Gy, stereotactic radiosurgery or brachytherapy unless the recurrence is histologically proven.
- Patients with clinically significant preexisting cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or symptomatic congestive heart failure are not eligible.
- Patients with known left ventricular ejection fraction (LVEF) < 40% are not eligible
- Patients with stroke (including TIA) or acute myocardial infarction within 3 months before the first dose of study treatment are not eligible
- Patients with any other clinically significant medical condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with study requirements including, but not limited to: ongoing or active infection, significant uncontrolled hypertension, or severe psychiatric illness/social situations.
- For each drug included in this protocol, specific inclusion and exclusion criteria (based on the Package Insert or manufacturers recommendations) may also apply. These can be found in the supplemental information about each agent included in the drug-specific study manuals. Drug-specific inclusion and exclusion criteria will take precedence over the inclusion/exclusion criteria listed above.
Trial locations and contacts
36 sites in 1 country. Contact the study team or a site near you to ask about taking part.
36 sites in 1 country
Netherlands36 sites, 35 recruiting
- Recruiting
Noordwest ziekenhuisgroep Alkmaar (NWZ)
Alkmaar
M.P. Hendriks, MD, PhD
M.P. Hendriks, MD, PhD
- Recruiting
Ziekenhuisgroep Twente
Almelo
E. Siemerink
E. Siemerink
- Recruiting
Meander medisch centrum
Amersfoort, 3818 ES
G.A. Cirkel, MD
G.A. Cirkel, MD
- Recruiting
Netherlands Cancer Institute
Amsterdam, 1066CX
E.E. Voest, prof., 0031205129111, DRUP@nki.nl
K Verkerk, MD, 0031205129111, DRUP@nki.nl
- Recruiting
Amsterdam UMC, locatie VUmc
Amsterdam, 1081 HV
M Labots
M Labots
- Active, not recruiting
Amsterdam UMC, locatie AMC
Amsterdam, 1105AZ
- Recruiting
Onze Lieve Vrouwe Gasthuis (OLVG)
Amsterdam
E.D. Kerver
E.D. Kerver
- Recruiting
Gelre ziekenhuizen
Apeldoorn
S.C.S. Tromp
S.C.S. Tromp
- Recruiting
Rijnstate ziekenhuis
Arnhem
T. van Voorthuizen
T. van Voorthuizen
- Recruiting
Amphia Ziekenhuis
Breda
H. Westgeest, MD, PhD
H. Westgeest, MD, PhD
- Recruiting
Reiner de Graaf Gasthuis
Delft
A. Vulink
A. Vulink
- Recruiting
Deventer ziekenhuis
Deventer
A. Imholz
A. Imholz
- Recruiting
Nij Smellinghe Ziekenhuis
Drachten
S. Hovenga
S. Hovenga
- Recruiting
Ziekenhuis Gelderse Vallei
Ede
P. de Mol
P. de Mol
- Recruiting
Maxima Medisch Centrum
Eindhoven, 5631 BM
G Vreugdenhil, MD, PhD
G Vreugdenhil, MD, PhD
- Recruiting
Zuyderland medisch centrum
Geleen, 6162 BG
F.L.G. Erdkamp, MD
F.L.G. Erdkamp, MD
- Recruiting
Rivas zorggroep
Gorinchem
M.A. Davidis
M.A. Davidis
- Recruiting
Martini ziekenhuis
Groningen
J. van Rooijen
J. van Rooijen
- Recruiting
University Medical Center Groningen
Groningen
D.J.A. de Groot, MD, PhD
D.J.A. de Groot, MD, PhD
- Recruiting
Spaarne gasthuis
Haarlem
G.J. de Klerk
G.J. de Klerk
- Not yet recruiting
Tergooi MC
Hilversum
H.P. van den Berg
H.P. van den Berg
- Recruiting
Treant zorggroep
Hoogeveen
C. Oldenhuis
C. Oldenhuis
- Recruiting
Medisch Centrum Leeuwaarden
Leeuwarden
H. de Graaf
H. de Graaf
- Recruiting
Leiden University Medical Center
Leiden
A.J. Gelderblom, MD, PhD
A.J. Gelderblom, MD, PhD
- Recruiting
Maastricht University Medical Center
Maastricht
A. Hoeben, MD, PhD
A. Hoeben, MD, PhD
- Recruiting
St. Antonius ziekenhuis
Nieuwegein
M. Los
M. Los
- Recruiting
Radboud umc
Nijmegen, 6225GA
C.M.L. van Herpen, MD, PhD
C.M.L. van Herpen, MD, PhD
- Recruiting
Bravis ziekenhuis
Roosendaal
S. Boudewijns
S. Boudewijns
- Recruiting
St. Fransicus Gasthuis
Rotterdam, 3045 PM
A P Hamberg, MD
A P Hamberg, MD
- Recruiting
Erasmus MC
Rotterdam
M.J.A. de Jonge, MD, PhD
M.J.A. de Jonge, MD, PhD
- Recruiting
Haaglanden medisch centrum
The Hague
F. Jeurissen
F. Jeurissen
- Recruiting
Haga ziekenhuis
The Hague
D. Hautsma
D. Hautsma
- Recruiting
Elisabeth-TweeSteden Ziekenhuis
Tilburg, 5022 GC
L.V. Beerepoot, MD, PhD
L.V. Beerepoot, MD, PhD
- Recruiting
University Medical Center Utrecht
Utrecht, 3584CX
L.A. Devriese, MD, PhD
L.A. Devriese, MD, PhD
- Recruiting
VieCuri medisch centrum
Venlo
Y. van der Wouw
Y. van der Wouw
- Recruiting
Isala klinieken
Zwolle
J.W.B. de Groot
J.W.B. de Groot
About this study
Official title: A Dutch National Study on Behalf of the CPCT to Facilitate Patient Access to Commercially Available, Targeted Anti-cancer Drugs to Determine the Potential Efficacy in Treatment of Advanced Cancers With a Known Molecular Profile
This is a prospective, non-randomized clinical trial that aims to describe the efficacy and toxicity of commercially available, targeted anticancer drugs* prescribed for treatment of patients with advanced cancer with a potentially actionable variant as revealed by a genomic or protein expression test. The study also aims to simplify patient access to approved targeted therapies that are contributed to the program by collaborating pharmaceutical companies and to perform next generation sequencing on tumor biopsies for biomarker analyses. Eligible patients have an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma for which standard treatment options are no longer available and acceptable performance status and organ function. A genomic or protein expression test must have been performed on the tumor and the results must identify at least one potentially actionable molecular variant as defined in the protocol. Results from the molecular profiling test will be used to determine an appropriate drug(s) from among those available in the protocol. The choice of drug will be supported by a list of potential profiles, a molecular tumor board, a knowledge library and by study coordinators for review and approval of the match. The protocol-specified treatment will be administered to the patient once any drug-specific eligibility criteria are confirmed and a fresh pre-treatment biopsy is performed for future genetic studies. All patients who receive treatment with a drug available in the protocol will be followed for standard efficacy outcomes including tumor response, progression-free and overall survival as well as duration of treatment. In addition, treatment related toxicity will be evaluated.
Read the detailed description
Problem description: evidence is building that matching targeted agents to tumor characteristics can improve outcomes. Such reports have fueled interest among patients and physicians to use molecular testing for treatment planning when standard treatment options have been exhausted. When oncologists aim to provide such personalized treatment to their patients though, obtaining the drugs can be challenging since off-label prescribing, while legal, is generally not reimbursed by insurance companies. Furthermore, outcomes of off-label treatment in routine clinical practice are not systematically recorded. As a result, the research and clinical communities have limited insight in these outcomes, leading to repetitive use of ineffective treatment for some tumor types, while effective treatment strategies might be missed for others. The latter is especially relevant for 'orphan diseases', that are too rare to conduct formal phase II and III trials. In summary, there is a lack of access to potentially effective therapy on one hand, and a lack of knowledge on broader use of such therapies on the other, altogether leading to sub-optimal use of available resources.
Envisioned solution and study aim: creation of a drug-access program, in which patients are treated with registered targeted therapy matched to their molecular tumor profile, and in which the outcomes of such therapies are recorded systematically, per tumor profile and tumor type (this is important since it is becoming increasingly clear that the tissue of origin is an important determinant of outcome of genetic abnormalities). We hereby aim to improve and broaden the use of registered targeted therapy, whilst facilitating patient access to such therapy.
Plan of investigation: patients will be treated with approved targeted agents, selected based on results of a molecular profiling test of the patient's tumor. Eligible patients will have exhausted standard treatment options, and their tumor must harbor a potentially actionable molecular variant as defined in the protocol. The study will provide a tumor board to help physicians understand the profiling test results and treatment options, and will enable insights about the utility of this approach. In addition, next generation sequencing will be performed on fresh tumor biopsies for additional biomarker discovery. Patients from the Netherlands and the USA will be included in two similar though independent protocols (DRUP and TAPUR), allowing data-exchange and empowering of both trials.
Expected outcome: early signs of clinical activity of approved drugs outside their label, providing effective personalized treatment options, improved patient outcomes and access to targeted therapy.
- Being tested
- Panitumumab, Olaparib, Dabrafenib, Nilotinib, Trametinib
- Keywords
- Molecular tumor profile, Multidisciplinary tumor board, Antitumor drugs, Molecular Targeted Therapy, Drug Repositioning, Off-Label Use, Sequence Analysis, DNA
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PanitumumabDrug
Also called Vectibix
Panitumumab treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of panitumumab might be expected based on their molecular tumor profile.
OlaparibDrug
Also called Lynparza
Olaparib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of olaparib might be expected based on their molecular tumor profile.
DabrafenibDrug
Also called Tafinlar
Dabrafenib treatment for patients with an mutated advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of dabrafenib might be expected based on their molecular tumor profile.
NilotinibDrug
Also called Tasigna
Nilotinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of nilotinib might be expected based on their molecular tumor profile.
TrametinibDrug
Also called Mekinist
Trametinib treatment for patients with an mutated advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of trametinib might be expected based on their molecular tumor profile.
ErlotinibDrug
Also called Tarceva
Erlotinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of erlotinib might be expected based on their molecular tumor profile.
Trastuzumab and Pertuzumab (combination treatment)Drug
Also called Herceptin + Perjeta
Trastuzumab and Pertuzumab treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of trastuzumab + pertuzumab might be expected based on their molecular tumor profile.
Vemurafenib and Cobimetinib (combination treatment)Drug
Also called Zelboraf + Cotellic
Vemurafenib + Cobimetinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Vemurafenib + Cobimetinib might be expected based on their molecular tumor profile.
VismodegibDrug
Also called Erivedge
Vismodegib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of vismodegib might be expected based on their molecular tumor profile.
RegorafenibDrug
Also called Stivarga
Regorafenib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of vismodegib might be expected based on their molecular tumor profile.
NivolumabDrug
Also called Opdivo
Nivolumab treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of nivolumab might be expected based on their molecular tumor profile.
AfatinibDrug
Also called Giotrif
Afatinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Afatinib might be expected based on their molecular tumor profile.
Dabrafenib and trametinibDrug
Also called Tafinlar and Mekinist
Dabrafenib + trametinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Dabrafenib + Trametinib might be expected based on their molecular tumor profile.
RibociclibDrug
Also called Kisqali
Ribociclib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Ribociclib might be expected based on their molecular tumor profile.
LenvatinibDrug
Also called Lenvima
Lenvatinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Lenvatinib might be expected based on their molecular tumor profile.
PembrolizumabDrug
Also called Keytruda
Pembrolizumab treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Pembrolizumab might be expected based on their molecular tumor profile.
DurvalumabDrug
Also called MEDI4736
Durvalumab treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Durvalumab might be expected based on their molecular tumor profile.
RucaparibDrug
Also called Rubraca
Rucaparib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Rucaparib might be expected based on their molecular tumor profile.
AxitinibDrug
Also called Inlyta
Axitinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Axitinib might be expected based on their molecular tumor profile.
PalbociclibDrug
Also called Ibrance
Palbociclib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Palbociclib might be expected based on their molecular tumor profile.
CrizotinibDrug
Also called Xalkori
Crizotinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Crizotinib might be expected based on their molecular tumor profile.
SunitinibDrug
Also called Sutent
Sunitinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Sunitinib might be expected based on their molecular tumor profile.
CabozantinibDrug
Also called Cabometyx
Cabozantinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Cabozantinib might be expected based on their molecular tumor profile.
AbemaciclibDrug
Also called Verzenios
Abemaciclib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Abemaciclib might be expected based on their molecular tumor profile.
AlectinibDrug
Also called Alecensa
Alectinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Alectinib might be expected based on their molecular tumor profile.
Atezolizumab and BevacizumabDrug
Also called Tecentriq and Avastin
Atezolizumab + Bevacizumab treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Atezolizumab + Bevacizumab might be expected based on their molecular tumor profile.
Ipilimumab and nivolumabDrug
Also called Yervoy and Opdivo
Ipilimumab+nivolumab treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of ipilimimab + nivolumab might be expected based on their molecular tumor profile.
EntrectinibDrug
Also called Rozlytrek
Entrectinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of entrectinib might be expected based on their molecular tumor profile.
TalazoparibDrug
Also called Talzenna
Talazoparib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of talazoparib might be expected based on their molecular tumor profile.
DacomitinibDrug
Also called Vizimpro
Dacomitinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of dacomitinib might be expected based on their molecular tumor profile.
LorlatinibDrug
Also called Lorviqua
Lorlatinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of lorlatinib might be expected based on their molecular tumor profile.
ErdafitinibDrug
Also called Balversa
Erdafitinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of erdafitinib might be expected based on their molecular tumor profile.
AlpelisibDrug
Also called Piqray
Alpelisib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of alpelisib might be expected based on their molecular tumor profile.
NiraparibDrug
Also called Zejula
Niraparib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of niraparib might be expected based on their molecular tumor profile.
PemigatinibDrug
Also called Pemazyre
Pemigatinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of pemigatinib might be expected based on their molecular tumor profile.
SelpercatinibDrug
Also called Retsevmo
Selpercatinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of selpercatinib might be expected based on their molecular tumor profile.
TepotinibDrug
Also called Tepmetko
Tepotinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of tepotinib might be expected based on their molecular tumor profile.
| Study group | Role | What they receive |
|---|---|---|
| Panitumumab | Experimental | Panitumumab for patients with a molecular tumor profile that can potentially be targeted by Panitumumab. Receives: Drug: Panitumumab |
| Olaparib | Experimental | Olaparib for patients with a molecular tumor profile that can potentially be targeted by Olaparib. Receives: Drug: Olaparib |
| Dabrafenib | Experimental | Dabrafenib for patients with a molecular tumor profile that can potentially be targeted by Dabrafenib. Receives: Drug: Dabrafenib |
| Nilotinib | Experimental | Nilotinib for patients with a molecular tumor profile that can potentially be targeted by nilotinib. Receives: Drug: Nilotinib |
| Trametinib | Experimental | Trametinib for patients with a molecular tumor profile that can potentially be targeted by trametinib. Receives: Drug: Trametinib |
| Erlotinib | Experimental | Erlotinib for patients with a molecular tumor profile that can potentially be targeted by erlotinib. Receives: Drug: Erlotinib |
| Trastuzumab & Pertuzumab (combination) | Experimental | Trastuzumab and Pertuzumab (combination treatment) for patients with a molecular tumor profile that can potentially be targeted by Trastuzumab and Pertuzumab. Receives: Drug: Trastuzumab and Pertuzumab (combination treatment) |
| Vemurafenib & Cobimetinib (combination) | Experimental | Vemurafenib and Cobimetinib (combination treatment) for patients with a molecular tumor profile that can potentially be targeted by Vemurafenib and Cobimetinib. Receives: Drug: Vemurafenib and Cobimetinib (combination treatment) |
| Vismodegib | Experimental | Vismodegib for patients with a molecular tumor profile that can potentially be targeted by vismodegib. Receives: Drug: Vismodegib |
| Regorafenib | Experimental | Regorafenib for patients with a molecular tumor profile that can potentially be targeted by regorafenib. Receives: Drug: Regorafenib |
| Nivolumab | Experimental | Nivolumab for patients with a molecular tumor profile that can potentially be targeted by nivolumab. Receives: Drug: Nivolumab |
| Afatinib | Experimental | Afatinib for patients with a molecular tumor profile that can potentially be targeted by Afatinib. Receives: Drug: Afatinib |
| Dabrafenib & trametinib (combination) | Experimental | Dabrafenib and trametinib (combination treatment) for patients with a molecular tumor profile that can potentially be targeted by Dabrafenib and trametinib. Receives: Drug: Dabrafenib and trametinib |
| Ribociclib | Experimental | Ribociclib for patients with a molecular tumor profile that can potentially be targeted by Ribociclib. Receives: Drug: Ribociclib |
| Lenvatinib | Experimental | Lenvatinib for patients with a molecular tumor profile that can potentially be targeted by Lenvatinib. Receives: Drug: Lenvatinib |
| Pembrolizumab | Experimental | Pembrolizumab for patients with a molecular tumor profile that can potentially be targeted by Pembrolizumab. Receives: Drug: Pembrolizumab |
| Durvalumab | Experimental | Durvalumab for patients with a molecular tumor profile that can potentially be targeted by Durvalumab. Receives: Drug: Durvalumab |
| Rucaparib | Experimental | Rucaparib for patients with a molecular tumor profile that can potentially be targeted by Rucaparib. Receives: Drug: Rucaparib |
| Axitinib | Experimental | Axitinib for patients with a molecular tumor profile that can potentially be targeted by Axitinib. Receives: Drug: Axitinib |
| Palbociclib | Experimental | Palbociclib for patients with a molecular tumor profile that can potentially be targeted by Palbociclib. Receives: Drug: Palbociclib |
| Crizotinib | Experimental | Crizotinib for patients with a molecular tumor profile that can potentially be targeted by Crizotinib. Receives: Drug: Crizotinib |
| Sunitinib | Experimental | Sunitinib for patients with a molecular tumor profile that can potentially be targeted by Sunitinib. Receives: Drug: Sunitinib |
| Cabozantinib | Experimental | Cabozantinib for patients with a molecular tumor profile that can potentially be targeted by Cabozantinib. Receives: Drug: Cabozantinib |
| Abemaciclib | Experimental | Abemaciclib for patients with a molecular tumor profile that can potentially be targeted by Abemaciclib. Receives: Drug: Abemaciclib |
| Alectinib | Experimental | Alectinib for patients with a molecular tumor profile that can potentially be targeted by Alectinib. Receives: Drug: Alectinib |
| Atezolizumab/bevacizumab | Experimental | Atezolizumab and bevacizumab (combination treatment) for patients with a molecular tumor profile that can potentially be targeted by Atezolizumab and bevacizumab. Receives: Drug: Atezolizumab and Bevacizumab |
| Ipilimumab/nivolumab | Experimental | Ipilimumab and nivolumab (combination treatment) for patients with a molecular tumor profile that can potentially be targeted by Ipilimumab and nivolumab. Receives: Drug: Ipilimumab and nivolumab |
| Entrectinib | Experimental | Entrectinib for patients with a molecular tumor profile that can potentially be targeted by entrectinib. Receives: Drug: Entrectinib |
| Talazoparib | Experimental | Talazoparib for patients with a molecular tumor profile that can potentially be targeted by talazoparib. Receives: Drug: Talazoparib |
| dacomitinib | Experimental | Dacomitinib for patients with a molecular tumor profile that can potentially be targeted by dacomitinib. Receives: Drug: Dacomitinib |
| Lorlatinib | Experimental | Lorlatinib for patients with a molecular tumor profile that can potentially be targeted by lorlatinib. Receives: Drug: Lorlatinib |
| Erdafitinib | Experimental | Erdafitinib for patients with a molecular tumor profile that can potentially be targeted by erdafitinib. Receives: Drug: Erdafitinib |
| Alpelisib | Experimental | Alpelisib for patients with a molecular tumor profile that can potentially be targeted by alpelisib. Receives: Drug: Alpelisib |
| Niraparib | Experimental | Niraparib for patients with a molecular tumor profile that can potentially be targeted by niraparib. Receives: Drug: Niraparib |
| Pemigatinib | Experimental | Pemigatinib for patients with a molecular tumor profile that can potentially be targeted by pemigatinib. Receives: Drug: Pemigatinib |
| Selpercatinib | Experimental | Selpercatinib for patients with a molecular tumor profile that can potentially be targeted by selpercatinib. Receives: Drug: Selpercatinib |
| Tepotinib | Experimental | Tepotinib for patients with a molecular tumor profile that can potentially be targeted by tepotinib. Receives: Drug: Tepotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients that are treated based on their molecular tumor profile
Primary outcome measure 1 is the percentage of submitted patients, that can be treated based on their molecular tumor profile within the context of this protocol.
Measured: 6 months after treatment initiation (estimated average)
Objective tumor response
Primary outcome measure 2 is the proportion of study participants with an objective tumor response upon study treatment..
Measured: 6 months after treatment initiation (estimated average)
Stable disease
Primary outcome measure 3 is the proportion of study participants that has stable disease (SD) during study treatment.
Measured: 6 months after treatment initiation (estimated average)
Treatment-related grade≥3 and serious adverse events
Primary outcome measure 4 is the proportion of patients that experience treatment-related grade≥3 and /or serious adverse events.
Measured: 6 months after treatment initiation (estimated average)
Secondary outcomes (3)
Progression-free survival
Measured: Up to 1 year after study completion
Overall survival
Measured: Up to 1 year after study completion
Duration of treatment on study (time on drug)
Measured: 6 months after treatment initiation (estimated average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startAug 2016
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen, AstraZeneca, Bayer, Bristol-Myers Squibb, Novartis, Roche Pharma AG, Merck Sharp & Dohme LLC, Boehringer Ingelheim, Ipsen, Eisai Inc., Pfizer, Clovis Oncology - Pharma and, Eli Lilly and Company, Janssen, LP, GlaxoSmithKline, Incyte Corporation, Dutch Cancer Society, Stelvio for Life
- Responsible party
- Sponsor
- Investigators
- E.E. Voest, prof., Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02925234
- Sponsor's protocol ID
- M15DRU
- Acronym
- DRUP
- Status last verified
- Jan 2024
- First submitted
- 26 Aug 2016
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Verkerk K, Spiekman AC, Haj Mohammad SF, Verbeek FAJ, Timmer H, van Maren MA, Zeverijn LJ, Geurts BS, van der Noort V, Roepman P, Jansen AML, de Leng WWJ, Gelderblom H, Verheul HMW, Voest EE; DRUP Trial Investigators. Prospective evaluation of genomics-guided off-label treatment. Nature. 2026 May;653(8114):558-566. doi: 10.1038/s41586-026-10405-x. Epub 2026 Apr 15.
PubMed 41986720Geurts BS, Zeverijn LJ, Leek LVM, van Berge Henegouwen JM, Hoes LR, van der Wijngaart H, van der Noort V, van de Haar J, van Ommen-Nijhof A, Kok M, Roepman P, Jansen AML, de Leng WWJ, de Jonge MJA, Hoeben A, van Herpen CML, Westgeest HM, Wessels LFA, Verheul HMW, Gelderblom H, Voest EE. Efficacy of Pembrolizumab and Biomarker Analysis in Patients with WGS-Based Intermediate to High Tumor Mutational Load: Results from the Drug Rediscovery Protocol. Clin Cancer Res. 2024 Sep 3;30(17):3735-3746. doi: 10.1158/1078-0432.CCR-24-0011.
PubMed 38630551Zeverijn LJ, Looze EJ, Thavaneswaran S, van Berge Henegouwen JM, Simes RJ, Hoes LR, Sjoquist KM, van der Wijngaart H, Sebastian L, Geurts BS, Lee CK, de Wit GF, Espinoza D, Roepman P, Lin FP, Jansen AML, de Leng WWJ, van der Noort V, Leek LVM, de Vos FYFL, van Herpen CML, Gelderblom H, Verheul HMW, Thomas DM, Voest EE. Limited clinical activity of palbociclib and ribociclib monotherapy in advanced cancers with cyclin D-CDK4/6 pathway alterations in the Dutch DRUP and Australian MoST trials. Int J Cancer. 2023 Oct 1;153(7):1413-1422. doi: 10.1002/ijc.34649. Epub 2023 Jul 10.
PubMed 37424386Geurts BS, Battaglia TW, van Berge Henegouwen JM, Zeverijn LJ, de Wit GF, Hoes LR, van der Wijngaart H, van der Noort V, Roepman P, de Leng WWJ, Jansen AML, Opdam FL, de Jonge MJA, Cirkel GA, Labots M, Hoeben A, Kerver ED, Bins AD, Erdkamp FGL, van Rooijen JM, Houtsma D, Hendriks MP, de Groot JB, Verheul HMW, Gelderblom H, Voest EE. Efficacy, safety and biomarker analysis of durvalumab in patients with mismatch-repair deficient or microsatellite instability-high solid tumours. BMC Cancer. 2023 Mar 4;23(1):205. doi: 10.1186/s12885-023-10663-2.
PubMed 36870947van Berge Henegouwen JM, van der Wijngaart H, Zeverijn LJ, Hoes LR, Meertens M, Huitema ADR, Devriese LA, Labots M, Verheul HMW, Voest EE, Gelderblom H. Efficacy and toxicity of vemurafenib and cobimetinib in relation to plasma concentrations, after administration via feeding tube in patients with BRAF-mutated thyroid cancer: a case series and review of literature. Cancer Chemother Pharmacol. 2022 Jul;90(1):97-104. doi: 10.1007/s00280-022-04437-z. Epub 2022 May 22.
PubMed 35598186Nakauma-Gonzalez JA, Rijnders M, van Riet J, van der Heijden MS, Voortman J, Cuppen E, Mehra N, van Wilpe S, Oosting SF, Rijstenberg LL, Westgeest HM, Zwarthoff EC, de Wit R, van der Veldt AAM, van de Werken HJG, Lolkema MPJ, Boormans JL. Comprehensive Molecular Characterization Reveals Genomic and Transcriptomic Subtypes of Metastatic Urothelial Carcinoma. Eur Urol. 2022 Apr;81(4):331-336. doi: 10.1016/j.eururo.2022.01.026. Epub 2022 Jan 25.
PubMed 35086719
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dutch National Study on Behalf of the CPCT to Facilitate Patient Access to Commercially Available, Targeted Anti-cancer Drugs to Determine the Potential Efficacy in Treatment of Advanced Cancers With a Known Molecular Profile
- ClinicalTrials.gov ID
- NCT02925234
- Acronym / sponsor ID
- DRUP / M15DRU
- Keywords
- Molecular tumor profile, Multidisciplinary tumor board, Antitumor drugs, Molecular Targeted Therapy, Drug Repositioning, Off-Label Use, Sequence Analysis, DNA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,550 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Collaborators
- Amgen, AstraZeneca, Bayer, Bristol-Myers Squibb, Novartis, Roche Pharma AG, Merck Sharp & Dohme LLC, Boehringer Ingelheim, Ipsen, Eisai Inc., Pfizer, Clovis Oncology - Pharma and, Eli Lilly and Company, Janssen, LP, GlaxoSmithKline, Incyte Corporation, Dutch Cancer Society, Stelvio for Life
- Study start
- Aug 2016 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, non-randomized clinical trial that aims to describe the efficacy and toxicity of commercially available, targeted anticancer drugs* prescribed for treatment of patients with advanced cancer with a potentially actionable variant as revealed by a genomic or protein expression test. The study also aims to simplify patient access to approved targeted therapies that are contributed to the program by collaborating pharmaceutical companies and to perform next generation sequencing on tumor biopsies for biomarker analyses. Eligible patients have an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma for which standard treatment options are no longer available and acceptable performance status and organ function. A genomic or protein expression test must have been performed on the tumor and the results must identify at least one potentially actionable molecular variant as defined in the protocol. Results from the molecular profiling test will be used to determine an appropriate drug(s) from among those available in the protocol. The choice of drug will be supported by a list of potential profiles, a molecular tumor board, a knowledge library and by study coordinators for review and approval of the match. The protocol-specified treatment will be administered to the patient once any drug-specific eligibility criteria are confirmed and a fresh pre-treatment biopsy is performed for future genetic studies. All patients who receive treatment with a drug available in the protocol will be followed for standard efficacy outcomes including tumor response, progression-free and overall survival as well as duration of treatment. In addition, treatment related toxicity will be evaluated.
Detailed description
Problem description: evidence is building that matching targeted agents to tumor characteristics can improve outcomes. Such reports have fueled interest among patients and physicians to use molecular testing for treatment planning when standard treatment options have been exhausted. When oncologists aim to provide such personalized treatment to their patients though, obtaining the drugs can be challenging since off-label prescribing, while legal, is generally not reimbursed by insurance companies. Furthermore, outcomes of off-label treatment in routine clinical practice are not systematically recorded. As a result, the research and clinical communities have limited insight in these outcomes, leading to repetitive use of ineffective treatment for some tumor types, while effective treatment strategies might be missed for others. The latter is especially relevant for 'orphan diseases', that are too rare to conduct formal phase II and III trials. In summary, there is a lack of access to potentially effective therapy on one hand, and a lack of knowledge on broader use of such therapies on the other, altogether leading to sub-optimal use of available resources.
Envisioned solution and study aim: creation of a drug-access program, in which patients are treated with registered targeted therapy matched to their molecular tumor profile, and in which the outcomes of such therapies are recorded systematically, per tumor profile and tumor type (this is important since it is becoming increasingly clear that the tissue of origin is an important determinant of outcome of genetic abnormalities). We hereby aim to improve and broaden the use of registered targeted therapy, whilst facilitating patient access to such therapy.
Plan of investigation: patients will be treated with approved targeted agents, selected based on results of a molecular profiling test of the patient's tumor. Eligible patients will have exhausted standard treatment options, and their tumor must harbor a potentially actionable molecular variant as defined in the protocol. The study will provide a tumor board to help physicians understand the profiling test results and treatment options, and will enable insights about the utility of this approach. In addition, next generation sequencing will be performed on fresh tumor biopsies for additional biomarker discovery. Patients from the Netherlands and the USA will be included in two similar though independent protocols (DRUP and TAPUR), allowing data-exchange and empowering of both trials.
Expected outcome: early signs of clinical activity of approved drugs outside their label, providing effective personalized treatment options, improved patient outcomes and access to targeted therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 37
| Arm | Type | Receives |
|---|---|---|
| Panitumumab | Experimental | Drug: PanitumumabPanitumumab for patients with a molecular tumor profile that can potentially be targeted by Panitumumab. |
| Olaparib | Experimental | Drug: OlaparibOlaparib for patients with a molecular tumor profile that can potentially be targeted by Olaparib. |
| Dabrafenib | Experimental | Drug: DabrafenibDabrafenib for patients with a molecular tumor profile that can potentially be targeted by Dabrafenib. |
| Nilotinib | Experimental | Drug: NilotinibNilotinib for patients with a molecular tumor profile that can potentially be targeted by nilotinib. |
| Trametinib | Experimental | Drug: TrametinibTrametinib for patients with a molecular tumor profile that can potentially be targeted by trametinib. |
| Erlotinib | Experimental | Drug: ErlotinibErlotinib for patients with a molecular tumor profile that can potentially be targeted by erlotinib. |
| Trastuzumab & Pertuzumab (combination) | Experimental | Drug: Trastuzumab and Pertuzumab (combination treatment)Trastuzumab and Pertuzumab (combination treatment) for patients with a molecular tumor profile that can potentially be targeted by Trastuzumab and Pertuzumab. |
| Vemurafenib & Cobimetinib (combination) | Experimental | Drug: Vemurafenib and Cobimetinib (combination treatment)Vemurafenib and Cobimetinib (combination treatment) for patients with a molecular tumor profile that can potentially be targeted by Vemurafenib and Cobimetinib. |
| Vismodegib | Experimental | Drug: VismodegibVismodegib for patients with a molecular tumor profile that can potentially be targeted by vismodegib. |
| Regorafenib | Experimental | Drug: RegorafenibRegorafenib for patients with a molecular tumor profile that can potentially be targeted by regorafenib. |
| Nivolumab | Experimental | Drug: NivolumabNivolumab for patients with a molecular tumor profile that can potentially be targeted by nivolumab. |
| Afatinib | Experimental | Drug: AfatinibAfatinib for patients with a molecular tumor profile that can potentially be targeted by Afatinib. |
| Dabrafenib & trametinib (combination) | Experimental | Drug: Dabrafenib and trametinibDabrafenib and trametinib (combination treatment) for patients with a molecular tumor profile that can potentially be targeted by Dabrafenib and trametinib. |
| Ribociclib | Experimental | Drug: RibociclibRibociclib for patients with a molecular tumor profile that can potentially be targeted by Ribociclib. |
| Lenvatinib | Experimental | Drug: LenvatinibLenvatinib for patients with a molecular tumor profile that can potentially be targeted by Lenvatinib. |
| Pembrolizumab | Experimental | Drug: PembrolizumabPembrolizumab for patients with a molecular tumor profile that can potentially be targeted by Pembrolizumab. |
| Durvalumab | Experimental | Drug: DurvalumabDurvalumab for patients with a molecular tumor profile that can potentially be targeted by Durvalumab. |
| Rucaparib | Experimental | Drug: RucaparibRucaparib for patients with a molecular tumor profile that can potentially be targeted by Rucaparib. |
| Axitinib | Experimental | Drug: AxitinibAxitinib for patients with a molecular tumor profile that can potentially be targeted by Axitinib. |
| Palbociclib | Experimental | Drug: PalbociclibPalbociclib for patients with a molecular tumor profile that can potentially be targeted by Palbociclib. |
| Crizotinib | Experimental | Drug: CrizotinibCrizotinib for patients with a molecular tumor profile that can potentially be targeted by Crizotinib. |
| Sunitinib | Experimental | Drug: SunitinibSunitinib for patients with a molecular tumor profile that can potentially be targeted by Sunitinib. |
| Cabozantinib | Experimental | Drug: CabozantinibCabozantinib for patients with a molecular tumor profile that can potentially be targeted by Cabozantinib. |
| Abemaciclib | Experimental | Drug: AbemaciclibAbemaciclib for patients with a molecular tumor profile that can potentially be targeted by Abemaciclib. |
| Alectinib | Experimental | Drug: AlectinibAlectinib for patients with a molecular tumor profile that can potentially be targeted by Alectinib. |
| Atezolizumab/bevacizumab | Experimental | Drug: Atezolizumab and BevacizumabAtezolizumab and bevacizumab (combination treatment) for patients with a molecular tumor profile that can potentially be targeted by Atezolizumab and bevacizumab. |
| Ipilimumab/nivolumab | Experimental | Drug: Ipilimumab and nivolumabIpilimumab and nivolumab (combination treatment) for patients with a molecular tumor profile that can potentially be targeted by Ipilimumab and nivolumab. |
| Entrectinib | Experimental | Drug: EntrectinibEntrectinib for patients with a molecular tumor profile that can potentially be targeted by entrectinib. |
| Talazoparib | Experimental | Drug: TalazoparibTalazoparib for patients with a molecular tumor profile that can potentially be targeted by talazoparib. |
| dacomitinib | Experimental | Drug: DacomitinibDacomitinib for patients with a molecular tumor profile that can potentially be targeted by dacomitinib. |
| Lorlatinib | Experimental | Drug: LorlatinibLorlatinib for patients with a molecular tumor profile that can potentially be targeted by lorlatinib. |
| Erdafitinib | Experimental | Drug: ErdafitinibErdafitinib for patients with a molecular tumor profile that can potentially be targeted by erdafitinib. |
| Alpelisib | Experimental | Drug: AlpelisibAlpelisib for patients with a molecular tumor profile that can potentially be targeted by alpelisib. |
| Niraparib | Experimental | Drug: NiraparibNiraparib for patients with a molecular tumor profile that can potentially be targeted by niraparib. |
| Pemigatinib | Experimental | Drug: PemigatinibPemigatinib for patients with a molecular tumor profile that can potentially be targeted by pemigatinib. |
| Selpercatinib | Experimental | Drug: SelpercatinibSelpercatinib for patients with a molecular tumor profile that can potentially be targeted by selpercatinib. |
| Tepotinib | Experimental | Drug: TepotinibTepotinib for patients with a molecular tumor profile that can potentially be targeted by tepotinib. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Adult (age >18 years) patient with a histologically-proven locally advanced or metastatic solid tumor, multiple myeloma or B cell non-Hodgkin lymphomawith symptomatic disease progression or progression according to RECIST-criteria after standard anti-cancer treatment or for whom no such treatment is available or indicated.
- ECOG performance status 0-2
- Patients must have acceptable organ function as defined below. However, specific inclusion/exclusion criteria specified in the drug-specific study manual will take precedence:
- Patients must have objectively measurable disease (by physical or radiographic examination, according to RECIST v1.1 for patients with solid tumors, or according to IMWG, Lugano, RANO or GCIG criteria, resp., for patients with multiple myeloma, non-Hodgkin lymphoma, glioblastoma or ovarian cancer in case of CA125-based evaluation (please refer to appendices for further details).
- Results must be available from a tumor genomic or protein expression test. Eligible tests may include any of the following technologies: fluorescence in situ hybridization (FISH), polymerase chain reaction (PCR), comparative genomic hybridization (CGH), next generation sequencing (NGS) or immunohistochemistry (IHC). The test may have been performed on the primary tumor or a metastatic deposit, in a diagnostic laboratory or within the context of another CPCT study, and must reveal a potentially actionable variant as defined in Section 5. The test results (full pathology or molecular diagnostics report) must be uploaded in the eCRF.
Key exclusion criteria (15 listed)
- Ongoing toxicity > grade 2, other than alopecia.
- Patient is receiving any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement). Required wash out period prior to starting study treatment is at least two weeks. An exception is made for:
- Patient is pregnant or nursing.
- Patients with known active progressive brain metastases. Patients with previously treated brain metastases are eligible, provided that the patient has not experienced a seizure or had a clinically significant change in neurological status within the 3 months prior to registration. All patients with previously treated brain metastases must be stable for at least 1 month after completion of treatment and off steroid treatment prior to study enrollment.
- Patients with clinically significant preexisting cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or symptomatic congestive heart failure are not eligible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PanitumumabAlso: VectibixPanitumumab treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of panitumumab might be expected based on their molecular tumor profile. | Drug | Panitumumab |
| OlaparibAlso: LynparzaOlaparib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of olaparib might be expected based on their molecular tumor profile. | Drug | Olaparib |
| DabrafenibAlso: TafinlarDabrafenib treatment for patients with an mutated advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of dabrafenib might be expected based on their molecular tumor profile. | Drug | Dabrafenib |
| NilotinibAlso: TasignaNilotinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of nilotinib might be expected based on their molecular tumor profile. | Drug | Nilotinib |
| TrametinibAlso: MekinistTrametinib treatment for patients with an mutated advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of trametinib might be expected based on their molecular tumor profile. | Drug | Trametinib |
| ErlotinibAlso: TarcevaErlotinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of erlotinib might be expected based on their molecular tumor profile. | Drug | Erlotinib |
| Trastuzumab and Pertuzumab (combination treatment)Also: Herceptin + PerjetaTrastuzumab and Pertuzumab treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of trastuzumab + pertuzumab might be expected based on their molecular tumor profile. | Drug | Trastuzumab & Pertuzumab (combination) |
| Vemurafenib and Cobimetinib (combination treatment)Also: Zelboraf + CotellicVemurafenib + Cobimetinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Vemurafenib + Cobimetinib might be expected based on their molecular tumor profile. | Drug | Vemurafenib & Cobimetinib (combination) |
| VismodegibAlso: ErivedgeVismodegib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of vismodegib might be expected based on their molecular tumor profile. | Drug | Vismodegib |
| RegorafenibAlso: StivargaRegorafenib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of vismodegib might be expected based on their molecular tumor profile. | Drug | Regorafenib |
| NivolumabAlso: OpdivoNivolumab treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of nivolumab might be expected based on their molecular tumor profile. | Drug | Nivolumab |
| AfatinibAlso: GiotrifAfatinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Afatinib might be expected based on their molecular tumor profile. | Drug | Afatinib |
| Dabrafenib and trametinibAlso: Tafinlar and MekinistDabrafenib + trametinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Dabrafenib + Trametinib might be expected based on their molecular tumor profile. | Drug | Dabrafenib & trametinib (combination) |
| RibociclibAlso: KisqaliRibociclib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Ribociclib might be expected based on their molecular tumor profile. | Drug | Ribociclib |
| LenvatinibAlso: LenvimaLenvatinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Lenvatinib might be expected based on their molecular tumor profile. | Drug | Lenvatinib |
| PembrolizumabAlso: KeytrudaPembrolizumab treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Pembrolizumab might be expected based on their molecular tumor profile. | Drug | Pembrolizumab |
| DurvalumabAlso: MEDI4736Durvalumab treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Durvalumab might be expected based on their molecular tumor profile. | Drug | Durvalumab |
| RucaparibAlso: RubracaRucaparib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Rucaparib might be expected based on their molecular tumor profile. | Drug | Rucaparib |
| AxitinibAlso: InlytaAxitinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Axitinib might be expected based on their molecular tumor profile. | Drug | Axitinib |
| PalbociclibAlso: IbrancePalbociclib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Palbociclib might be expected based on their molecular tumor profile. | Drug | Palbociclib |
| CrizotinibAlso: XalkoriCrizotinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Crizotinib might be expected based on their molecular tumor profile. | Drug | Crizotinib |
| SunitinibAlso: SutentSunitinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Sunitinib might be expected based on their molecular tumor profile. | Drug | Sunitinib |
| CabozantinibAlso: CabometyxCabozantinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Cabozantinib might be expected based on their molecular tumor profile. | Drug | Cabozantinib |
| AbemaciclibAlso: VerzeniosAbemaciclib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Abemaciclib might be expected based on their molecular tumor profile. | Drug | Abemaciclib |
| AlectinibAlso: AlecensaAlectinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Alectinib might be expected based on their molecular tumor profile. | Drug | Alectinib |
| Atezolizumab and BevacizumabAlso: Tecentriq and AvastinAtezolizumab + Bevacizumab treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Atezolizumab + Bevacizumab might be expected based on their molecular tumor profile. | Drug | Atezolizumab/bevacizumab |
| Ipilimumab and nivolumabAlso: Yervoy and OpdivoIpilimumab+nivolumab treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of ipilimimab + nivolumab might be expected based on their molecular tumor profile. | Drug | Ipilimumab/nivolumab |
| EntrectinibAlso: RozlytrekEntrectinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of entrectinib might be expected based on their molecular tumor profile. | Drug | Entrectinib |
| TalazoparibAlso: TalzennaTalazoparib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of talazoparib might be expected based on their molecular tumor profile. | Drug | Talazoparib |
| DacomitinibAlso: VizimproDacomitinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of dacomitinib might be expected based on their molecular tumor profile. | Drug | dacomitinib |
| LorlatinibAlso: LorviquaLorlatinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of lorlatinib might be expected based on their molecular tumor profile. | Drug | Lorlatinib |
| ErdafitinibAlso: BalversaErdafitinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of erdafitinib might be expected based on their molecular tumor profile. | Drug | Erdafitinib |
| AlpelisibAlso: PiqrayAlpelisib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of alpelisib might be expected based on their molecular tumor profile. | Drug | Alpelisib |
| NiraparibAlso: ZejulaNiraparib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of niraparib might be expected based on their molecular tumor profile. | Drug | Niraparib |
| PemigatinibAlso: PemazyrePemigatinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of pemigatinib might be expected based on their molecular tumor profile. | Drug | Pemigatinib |
| SelpercatinibAlso: RetsevmoSelpercatinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of selpercatinib might be expected based on their molecular tumor profile. | Drug | Selpercatinib |
| TepotinibAlso: TepmetkoTepotinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of tepotinib might be expected based on their molecular tumor profile. | Drug | Tepotinib |
Primary outcome
Percentage of patients that are treated based on their molecular tumor profile
Time frame: 6 months after treatment initiation (estimated average)
Primary outcome measure 1 is the percentage of submitted patients, that can be treated based on their molecular tumor profile within the context of this protocol.
Objective tumor response
Time frame: 6 months after treatment initiation (estimated average)
Primary outcome measure 2 is the proportion of study participants with an objective tumor response upon study treatment..
Stable disease
Time frame: 6 months after treatment initiation (estimated average)
Primary outcome measure 3 is the proportion of study participants that has stable disease (SD) during study treatment.
Treatment-related grade≥3 and serious adverse events
Time frame: 6 months after treatment initiation (estimated average)
Primary outcome measure 4 is the proportion of patients that experience treatment-related grade≥3 and /or serious adverse events.
3 secondary outcomes
Progression-free survival
Time frame: Up to 1 year after study completion
Overall survival
Time frame: Up to 1 year after study completion
Duration of treatment on study (time on drug)
Time frame: 6 months after treatment initiation (estimated average)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Derived from this study: PubMed 41986720Verkerk K, Spiekman AC, Haj Mohammad SF, Verbeek FAJ, Timmer H, van Maren MA, Zeverijn LJ, Geurts BS, van der Noort V, Roepman P, Jansen AML, de Leng WWJ, Gelderblom H, Verheul HMW, Voest EE; DRUP Trial Investigators. Prospective evaluation of genomics-guided off-label treatment. Nature. 2026 May;653(8114):558-566. doi: 10.1038/s41586-026-10405-x. Epub 2026 Apr 15.
- Derived from this study: PubMed 38630551Geurts BS, Zeverijn LJ, Leek LVM, van Berge Henegouwen JM, Hoes LR, van der Wijngaart H, van der Noort V, van de Haar J, van Ommen-Nijhof A, Kok M, Roepman P, Jansen AML, de Leng WWJ, de Jonge MJA, Hoeben A, van Herpen CML, Westgeest HM, Wessels LFA, Verheul HMW, Gelderblom H, Voest EE. Efficacy of Pembrolizumab and Biomarker Analysis in Patients with WGS-Based Intermediate to High Tumor Mutational Load: Results from the Drug Rediscovery Protocol. Clin Cancer Res. 2024 Sep 3;30(17):3735-3746. doi: 10.1158/1078-0432.CCR-24-0011.
- Derived from this study: PubMed 37424386Zeverijn LJ, Looze EJ, Thavaneswaran S, van Berge Henegouwen JM, Simes RJ, Hoes LR, Sjoquist KM, van der Wijngaart H, Sebastian L, Geurts BS, Lee CK, de Wit GF, Espinoza D, Roepman P, Lin FP, Jansen AML, de Leng WWJ, van der Noort V, Leek LVM, de Vos FYFL, van Herpen CML, Gelderblom H, Verheul HMW, Thomas DM, Voest EE. Limited clinical activity of palbociclib and ribociclib monotherapy in advanced cancers with cyclin D-CDK4/6 pathway alterations in the Dutch DRUP and Australian MoST trials. Int J Cancer. 2023 Oct 1;153(7):1413-1422. doi: 10.1002/ijc.34649. Epub 2023 Jul 10.
- Derived from this study: PubMed 36870947Geurts BS, Battaglia TW, van Berge Henegouwen JM, Zeverijn LJ, de Wit GF, Hoes LR, van der Wijngaart H, van der Noort V, Roepman P, de Leng WWJ, Jansen AML, Opdam FL, de Jonge MJA, Cirkel GA, Labots M, Hoeben A, Kerver ED, Bins AD, Erdkamp FGL, van Rooijen JM, Houtsma D, Hendriks MP, de Groot JB, Verheul HMW, Gelderblom H, Voest EE. Efficacy, safety and biomarker analysis of durvalumab in patients with mismatch-repair deficient or microsatellite instability-high solid tumours. BMC Cancer. 2023 Mar 4;23(1):205. doi: 10.1186/s12885-023-10663-2.
- Derived from this study: PubMed 35598186van Berge Henegouwen JM, van der Wijngaart H, Zeverijn LJ, Hoes LR, Meertens M, Huitema ADR, Devriese LA, Labots M, Verheul HMW, Voest EE, Gelderblom H. Efficacy and toxicity of vemurafenib and cobimetinib in relation to plasma concentrations, after administration via feeding tube in patients with BRAF-mutated thyroid cancer: a case series and review of literature. Cancer Chemother Pharmacol. 2022 Jul;90(1):97-104. doi: 10.1007/s00280-022-04437-z. Epub 2022 May 22.
- Derived from this study: PubMed 35086719Nakauma-Gonzalez JA, Rijnders M, van Riet J, van der Heijden MS, Voortman J, Cuppen E, Mehra N, van Wilpe S, Oosting SF, Rijstenberg LL, Westgeest HM, Zwarthoff EC, de Wit R, van der Veldt AAM, van de Werken HJG, Lolkema MPJ, Boormans JL. Comprehensive Molecular Characterization Reveals Genomic and Transcriptomic Subtypes of Metastatic Urothelial Carcinoma. Eur Urol. 2022 Apr;81(4):331-336. doi: 10.1016/j.eururo.2022.01.026. Epub 2022 Jan 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
E.E. Voest, prof. principal investigator
The Netherlands Cancer Institute
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Panitumumab, Olaparib and Dabrafenib in people with Cancer and Tumors, run by The Netherlands Cancer Institute at 36 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact E.E. Voest, prof. (0031205129111, DRUP@nki.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients that are treated based on their molecular tumor profile (time frame: 6 months after treatment initiation (estimated average)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02925234, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024; AzTrials last refreshed its copy on 29 Oct 2026.