Metastatic CancerPhase 2MetActionNCT02142036
N-of-1 Trial: Actionable Target Identification in Metastatic Cancer for Palliative Systemic Therapy
A Phase 2 study testing EMA-approved ATI based targeted therapy in people with Metastatic Cancer, run by Oslo University Hospital at 2 sites in Norway.
Trial summary
The metastatic lesions may be very different from the primary tumor because of intrinsic tumor heterogenity, clonal selection through metastatic process and following previous cytotoxic treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer
- What is being tested?
- EMA-approved ATI based targeted therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesNorway
- Study dates
- May 2014to Aug 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Metastatic cancer and progression by RECIST 1.0 evaluated by internal review on at least one prior regimen of established palliative systemic therapies for advanced disease and eligibility for repeat biopsy sampling. The patient must have received ≥6 weeks of the previous treatment. Only patients who have no other standard treatment option or were the treatment option is considered to offer the patients only minor benefit may be included in the study.
- Radiological evaluation intervals on last prior therapy (period A) must have been 6 to 12 weeks.
- At least one measurable lesions (>10mm on CT-scan) according to RECIST 1.0.
- Age ≥ 18 years. Eastern Cooperative Oncology Group (ECOG) performance status 1 or lower.
- Life expectancy of more than 3 months.
- Adequate bone marrow function without current use of colony-stimulating factors: Neutrophils ≥1.5 x109/l; Platelets ≥100 x109/l; Hb >10 g/dl, INR within normal level.
Show all 12Show fewer
- Adequate liver function: AST/ALT ≤5x ULN; Bilirubin ≤2x ULN, albumin >30 g/l.
- Adequate renal function: Creatinine ≤1.5x ULN.
- Be able to use recommended dose of the selected targeted therapy as described in the drug specific SPC.
- Be able to comply with the protocol.
- Fertile men and women must be willing to use effective contraceptives.
- Provide written (signed) informed consent to participate in the trial prior to any trial specific screening procedures.
Who cannot join
- Metastatic disease from more than one malignancy.
- Untreated or symptomatic brain metastasis (patients must be symptom-free without the use of corticosteroids).
- Any reason why, in the opinion of the investigator, the patient should not participate.
- Pregnancy.
- Breastfeeding
- Anticoagulation with coumarin derivatives.
- Radiation therapy within 4 weeks of start of treatment.
- Need to use medications contraindicated according to SPC of the different drugs.
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Akershus University Hospital
Lillestrøm, 1478
The Norwegian Radium Hospital
Oslo, 0379
About this study
Official title: N-of-1 Trial of Actionable Target Identification in Metastatic Cancer for Palliative Systemic Therapy
The metastatic lesions may be very different from the primary tumor because of intrinsic tumor heterogenity, clonal selection through metastatic process and following previous cytotoxic treatments. Metastatic tumor harboring actionable targets or signaling pathways may respond to inhibitory agents directed against specific aberrations irrespective of tumor origin. In the MetAction study, patients will receive therapy based on molecular aberrations in the metastatic lesions, actionable target identification (ATI), rather than on histological tumor type.
The ATI rate in an unselected metastatic patient population is uncertain, and response rates associated with ATI based targeted therapy have hardly been reported. In this perspective, The MetAction study is essentially a feasibility study aiming to tailor metastatic cancer therapy based on genomic profiles.
Read the detailed description
Recognizing the rapidly increasing number of drugs targeting specific molecular aberrations in cancer, it is necessary to define rational strategies to make such treatment available to Norwegian cancer patients.These targeted drugs are extremely costly and have significant side effects, although presumably to a lesser extent than many of the classic cytotoxic drugs available. Thus, in the interest of the patient in question and the society in general, it is important to give the right drug to the right patient and to the presumably right time in the disease course.
Hitherto, most of the drugs in question are given in the palliative setting, i.e. to patients with disseminated metastatic disease. The metastatic lesion may be very different from the primary tumor, and hence, it is rational to analyze the tumor to be treated, the metastatic lesion(s), for the presence of molecular aberrations, rather than basing treatment decisions on molecular features known to be present in a particular tumor type or in the primary tumor.
- Conditions
- Metastatic Cancer
- Being tested
- EMA-approved ATI based targeted therapy
- Keywords
- Metastatic disease, Metastasis, Targeted therapy, Solid tumor, Personalized medicine, N-of-1 trial
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMA-approved ATI based targeted therapyDrug
Also called Cetuximab, Panitumumab, Gefitinib, Erlotinib
All drugs that may be used in the study are approved by EMA for treatment of disseminated cancer in the palliative setting, but not for the particular tumor type in question.
| Study group | Role | What they receive |
|---|---|---|
| ATI based targeted therapy. | Experimental | EMA-approved ATI based targeted therapy. Patients will receive therapy based on molecular aberrations identified in the metastatic lesion. Receives: Drug: EMA-approved ATI based targeted therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Comparing the PFS using therapy selected by ATI in a patient's tumor (period B) with the PFS for the most recent therapy on which the patient had just experienced progression (period A). The ATI-selected therapy is defined as having benefit for the patient if PFS period B/PFS in period A ratio is ≥ 1.3.
Measured: From date of initiation of study treatment until the date of first documented progression or date of death, from any cause, whichever came first, assessed up to 24 months.
Secondary outcomes (2)
Overall response rate (ORR)
The sum of partial responses (PS) plus complete responses (CR).
Measured: From date of initiation of study treatment until the date of first documented progression, assessed up to 24 months.
Overall survival (OS)
Measured: From date of initiation of study treatment until date of death, from any cause, assessed up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startMay 2014
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway
- Responsible party
- Principal investigator, Kjersti Flatmark, Oslo University Hospital
- Investigators
- Kjersti Flatmark, MD PhD, Study chair, Oslo University HospitalSvein Dueland, MD, Principal investigator, Oslo University HospitalAnne Hansen Ree, Prof. MD PhD, Principal investigator, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142036
- Sponsor's protocol ID
- MetAction
- Acronym
- MetAction
- Status last verified
- Mar 2019
- First submitted
- 13 Apr 2014
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Ree AH, Maelandsmo GM, Flatmark K, Russnes HG, Gomez Castaneda M, Aas E. Cost-effectiveness of molecularly matched off-label therapies for end-stage cancer - the MetAction precision medicine study. Acta Oncol. 2022 Aug;61(8):955-962. doi: 10.1080/0284186X.2022.2098053. Epub 2022 Aug 9.
PubMed 35943168Ree AH, Nygaard V, Boye K, Heinrich D, Dueland S, Bergheim IR, Johansen C, Beiske K, Negard A, Lund-Iversen M, Nygaard V, Hovig E, Nakken S, Nasser S, Julsrud L, Reisse CH, Ruud EA, Kristensen VN, Florenes VA, Geitvik GA, Lingjaerde OC, Borresen-Dale AL, Russnes HG, Maelandsmo GM, Flatmark K. Molecularly matched therapy in the context of sensitivity, resistance, and safety; patient outcomes in end-stage cancer - the MetAction study. Acta Oncol. 2020 Jul;59(7):733-740. doi: 10.1080/0284186X.2020.1742377. Epub 2020 Mar 25.
PubMed 32208873
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- N-of-1 Trial of Actionable Target Identification in Metastatic Cancer for Palliative Systemic Therapy
- ClinicalTrials.gov ID
- NCT02142036
- Acronym / sponsor ID
- MetAction / MetAction
- Conditions
- Metastatic Cancer
- Keywords
- Metastatic disease, Metastasis, Targeted therapy, Solid tumor, Personalized medicine, N-of-1 trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- The Research Council of Norway
- Study start
- May 2014 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 20 May 2014 (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.
The metastatic lesions may be very different from the primary tumor because of intrinsic tumor heterogenity, clonal selection through metastatic process and following previous cytotoxic treatments. Metastatic tumor harboring actionable targets or signaling pathways may respond to inhibitory agents directed against specific aberrations irrespective of tumor origin. In the MetAction study, patients will receive therapy based on molecular aberrations in the metastatic lesions, actionable target identification (ATI), rather than on histological tumor type.
The ATI rate in an unselected metastatic patient population is uncertain, and response rates associated with ATI based targeted therapy have hardly been reported. In this perspective, The MetAction study is essentially a feasibility study aiming to tailor metastatic cancer therapy based on genomic profiles.
Detailed description
Recognizing the rapidly increasing number of drugs targeting specific molecular aberrations in cancer, it is necessary to define rational strategies to make such treatment available to Norwegian cancer patients.These targeted drugs are extremely costly and have significant side effects, although presumably to a lesser extent than many of the classic cytotoxic drugs available. Thus, in the interest of the patient in question and the society in general, it is important to give the right drug to the right patient and to the presumably right time in the disease course.
Hitherto, most of the drugs in question are given in the palliative setting, i.e. to patients with disseminated metastatic disease. The metastatic lesion may be very different from the primary tumor, and hence, it is rational to analyze the tumor to be treated, the metastatic lesion(s), for the presence of molecular aberrations, rather than basing treatment decisions on molecular features known to be present in a particular tumor type or in the primary tumor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ATI based targeted therapy. | Experimental | Drug: EMA-approved ATI based targeted therapyEMA-approved ATI based targeted therapy. Patients will receive therapy based on molecular aberrations identified in the metastatic lesion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Metastatic cancer and progression by RECIST 1.0 evaluated by internal review on at least one prior regimen of established palliative systemic therapies for advanced disease and eligibility for repeat biopsy sampling. The patient must have received ≥6 weeks of the previous treatment. Only patients who have no other standard treatment option or were the treatment option is considered to offer the patients only minor benefit may be included in the study.
- Radiological evaluation intervals on last prior therapy (period A) must have been 6 to 12 weeks.
- At least one measurable lesions (>10mm on CT-scan) according to RECIST 1.0.
- Age ≥ 18 years. Eastern Cooperative Oncology Group (ECOG) performance status 1 or lower.
- Life expectancy of more than 3 months.
Key exclusion criteria (8 listed)
- Metastatic disease from more than one malignancy.
- Untreated or symptomatic brain metastasis (patients must be symptom-free without the use of corticosteroids).
- Any reason why, in the opinion of the investigator, the patient should not participate.
- Pregnancy.
- Breastfeeding
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 |
|---|---|---|
| EMA-approved ATI based targeted therapyAlso: Cetuximab, Panitumumab, Gefitinib, ErlotinibAll drugs that may be used in the study are approved by EMA for treatment of disseminated cancer in the palliative setting, but not for the particular tumor type in question. | Drug | ATI based targeted therapy. |
Primary outcome
Progression-free survival (PFS)
Time frame: From date of initiation of study treatment until the date of first documented progression or date of death, from any cause, whichever came first, assessed up to 24 months.
Comparing the PFS using therapy selected by ATI in a patient's tumor (period B) with the PFS for the most recent therapy on which the patient had just experienced progression (period A). The ATI-selected therapy is defined as having benefit for the patient if PFS period B/PFS in period A ratio is ≥ 1.3.
2 secondary outcomes
Overall response rate (ORR)
Time frame: From date of initiation of study treatment until the date of first documented progression, assessed up to 24 months.
Overall survival (OS)
Time frame: From date of initiation of study treatment until date of death, from any cause, assessed up to 24 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Derived from this study: PubMed 35943168Ree AH, Maelandsmo GM, Flatmark K, Russnes HG, Gomez Castaneda M, Aas E. Cost-effectiveness of molecularly matched off-label therapies for end-stage cancer - the MetAction precision medicine study. Acta Oncol. 2022 Aug;61(8):955-962. doi: 10.1080/0284186X.2022.2098053. Epub 2022 Aug 9.
- Derived from this study: PubMed 32208873Ree AH, Nygaard V, Boye K, Heinrich D, Dueland S, Bergheim IR, Johansen C, Beiske K, Negard A, Lund-Iversen M, Nygaard V, Hovig E, Nakken S, Nasser S, Julsrud L, Reisse CH, Ruud EA, Kristensen VN, Florenes VA, Geitvik GA, Lingjaerde OC, Borresen-Dale AL, Russnes HG, Maelandsmo GM, Flatmark K. Molecularly matched therapy in the context of sensitivity, resistance, and safety; patient outcomes in end-stage cancer - the MetAction study. Acta Oncol. 2020 Jul;59(7):733-740. doi: 10.1080/0284186X.2020.1742377. Epub 2020 Mar 25.
- Individual participant dataSharing planned: Undecided
Related trials for Metastatic Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingObservational study
A Non-Interventional Study PASS to Characterize Secondary Malignancies of Tcell Origin Following Tisagenlecleucel Therapy
Secondary Malignancies of T-cell Origin
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. This study is not recruiting at the moment.
Kjersti Flatmark, MD PhD study chair
Oslo University Hospital
Svein Dueland, MD principal investigator
Oslo University Hospital
Anne Hansen Ree, Prof. MD PhD principal investigator
University Hospital, Akershus
2 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 EMA-approved ATI based targeted therapy in people with Metastatic Cancer, run by Oslo University Hospital at 2 sites in Norway.
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 12 inclusion and 8 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: finished, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: From date of initiation of study treatment until the date of first documented progression or date of death, from any cause, whichever came first, assessed up to 24 months.). 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 NCT02142036, which also lists 2 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 13 Mar 2019.