Mantle Cell LymphomaPhase 1/2NCT02356458
Combination of Ibrutinib and Bortezomib to Treat Patients With Mantle Cell Lymphoma
A Phase 1/2 study testing Ibrutinib and bortezomib in people with Mantle Cell Lymphoma, run by Swiss Cancer Institute at 19 sites in 3 countries.
Trial summary
Mantle cell lymphoma (MCL) remains an incurable disease with frequent relapses and no standard therapeutic options in case of relapse. Prolongation of remissions or induction of longer remissions is therefore crucial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mantle Cell Lymphoma
- What is being tested?
- Ibrutinib and bortezomib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 19 sitesin 3 countries
- Study dates
- 31 Aug 2015to 30 Mar 2021
- Phase
- Phase 1/2
- 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
- Patient must give written informed consent before registration indicating that the patient understands the purpose of the procedures required for the trial and is willing to participate in the trial.
- Histologically confirmed mantle cell lymphoma with either overexpression of cyclin D1 protein or evidence of t(11;14)(q13;q32) assessed by cytogenetics, by fluorescence, in situ hybridization (FISH) or by polymerase chain reaction (PCR).
- Refractory or relapsed disease in need of systemic therapy after pretreatment with non-bortezomib-containing chemotherapy (including high-dose therapy)
- At least one measurable lesion ≥11 mm in its greatest transverse diameter measured with CT scan (contrast enhanced) or MRI (in case of the disease cannot be adequately imaged using CT and if contrast is not appropriate for patients according to the treating physician)
- WHO performance status 0-2
- Age ≥ 18 years
Show all 18Show fewer
- Adequate hematological values:
- Absolute neutrophil count (ANC) > 1.0 x 109/L independent of growth factor support
- Platelets ≥ 100 x 109/L or ≥ 50 x 109/L if bone marrow involvement independent of transfusion support in either situation,
- Hb ≥ 80 g/L
- Adequate hepatic function:
- Total bilirubin ≤1.5xupper limit of normal (ULN) unless bilirubin is due to Gilbert's syndrome ≤ 5.0 x ULN
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3xULN
- Adequate renal function: Body surface area (BSA) corrected creatinine clearance >40mL/min/1.73m2 (calculated according to the formula of Cockcroft-Gault)
- Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the trial (see below) consistent with local regulations regarding the use of birth control methods for patients participating in clinical trials (see section 9.12). Men must agree to not donate sperm during and after the trial. These restrictions apply for
- Ibrutinib: 3 month after the last dose of trial drug for males and 1 month for females.
- Bortezomib: during trial treatment (for males and females): no restrictions of birth control after last dose of trial drug. Donation of sperm: 6 month after the last dose of trial drug.
- Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [β-hCG]) or urine pregnancy test at baseline. Women who are pregnant or breastfeeding are ineligible for this trial.
Who cannot join
- Prior therapy with ibrutinib or bortezomib
- Adverse event neuropathy of prior therapy grade ≥2 (according to CTCAE criteria) at registration
- Previous malignancy within 5 years with the exception of adequately treated in situ cervical cancer or localized non-melanoma skin cancer.
- Presence or history of CNS disease (either CNS lymphoma or lymphomatous meningeosis)
- Evidence of ongoing systemic infections of all kind
- Exclusion of the following prior treatments prior to trial registration
Show all 26Show fewer
- major surgery within 4 weeks
- concurrent treatment with other experimental drugs or treatment in a clinical trial within 30 days.
- treatment with chemotherapy and radiotherapy within ≥ 3 weeks
- vaccinated with live, attenuated vaccines within 4 weeks
- History of stroke or intracranial hemorrhage within 6 months prior to trial registration.
- Requires anticoagulation with warfarin or equivalent vitamin K antagonists (e.g. phenprocoumon)
- Requires treatment with strong or moderate CYP3A inhibitors (see http://medicine.iupui.edu/)
- Clinically significant cardiovascular disease such as congestive heart failure NYHA III or IV (as defined by the New York Heart Association Functional Classification), uncontrolled or symptomatic arrhythmias, significant QT-prolongation, unstable angina pectoris myocardial infarction within 6 months of prior to registration,
- Known history of human immunodeficiency virus (HIV) or active Hepatitis C virus or active Hepatitis B virus infection or any uncontrolled active systemic infection requiring treatment.
- Prior allogeneic bone marrow or solid organ transplantation
- Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion,
- could impair the ability of the patient to participate in the trial
- could compromise the patient's safety,
- could interfere with the absorption or metabolism of ibrutinib capsules, or
- could put the trial outcomes at undue risk
- could prevent compliance with trial treatment.
- Psychiatric disorder precluding understanding of trial information, giving informed consent, or interfering with compliance for oral drug intake.
- Known hypersensitivity to trial drug(s) or hypersensitivity to any other component of the trial drugs.
- Any concomitant drugs contraindicated for use with the trial drugs according to the approved product information.
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the trial protocol and follow-up.
Trial locations and contacts
19 sites in 3 countries.
19 sites in 3 countries
Switzerland13 sites
Kantonsspital Aarau
Aarau, CH-5001
Kantonsspital Baden
Baden, 5404
Inselspital, Bern
Bern, CH-3010
Kantonsspital Graubünden
Chur, 7000
Hopitaux Universitaires de Geneve
Geneva, 1211
Centre Pluridisciplinaire d'Oncologie CHUV
Lausanne, 1011
Kantonsspital Baselland
Liestal, 4410
Istituto Oncologico della Svizzera Italiana
Lugano, CH-6900
Kantonsspital Luzern
Luzerne, CH-6000
Kantonsspital - St. Gallen
Sankt Gallen, CH-9007
Onkozentrum - Klinik Im Park
Zurich, 8038
UniversitätsSpital Zürich
Zurich, 8091
Klinik Hirslanden
Zurich, CH-8032
Germany3 sites
Universitätsmedizin Mainz
Mainz, 55131
Klinikum der Universität München
München, 81377
Universitätsmedizin Rostock
Rostock, 18057
Italy3 sites
Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo
Alessandria, 15100
European Institute of Oncology
Milan, 20141
Università di Torino
Torino, 10126
About this study
Official title: Combination of Ibrutinib and Bortezomib Followed by Ibrutinib Maintenance to Treat Patients With Relapsed and Refractory Mantle Cell Lymphoma; a Multicenter Phase I/II Trial.
Mantle cell lymphoma (MCL) remains an incurable disease with frequent relapses and no standard therapeutic options in case of relapse. Prolongation of remissions or induction of longer remissions is therefore crucial. Recently, a synergistic increase in the proteasomal inhibition of ibrutinib in both bortezomib-sensitive and refractory MCL cells was shown. These findings, along with the reported single agent activities of both drugs and the non-overlapping toxicities, are the rationale to combine ibrutinib and bortezomib in MCL in this trial
Read the detailed description
Disease background, therapy background and aim
Mantle cell lymphoma (MCL) is a distinct subtype of B-cell lymphoma. It represents ~5% of all lymphomas and typically is present in advanced stages, a median age of 60-65 years and a dismal prognosis with a median survival of ~3 years. Currently, it remains incurable, as the patients will relapse after first line treatment and require subsequent therapy. The disease-free survival is progressively shorter with each subsequent relapse.
Currently, there is no standard therapy for relapsed MCL patients. MCL is predominantly a disease of the elderly who are not suitable for aggressive chemotherapy. Allogeneic transplants are preferred in young and fit patients, whereas (preferably single agent) chemotherapy is used to treat older patients, but usually with short duration of responses. Recently, the therapeutic armamentarium has been expanded with the availability of novel agents targeting crucial and deregulated pathways in MCL. These include the Bruton's Kinase (BTK) inhibitor ibrutinib with excellent single agent activities. New therapeutic options in the targeted patient population are clearly needed to prolong remissions especially for elderly patients where aggressive chemotherapy and allogeneic transplants are no suitable treatment options. Recently, a synergistic increase in the proteasomal inhibition of ibrutinib in both bortezomib-sensitive and refractory MCL cells was shown.
This trial is targeting patients with diagnosis of refractory or relapsed MCL disease after pretreatment with ≤2 lines of non-bortezomib-containing chemotherapy. The proposed treatment of ibrutinib in combination with bortezomib might lead to an improvement of the therapy in the targeted relapsed/refractory patient population. Given the absence of a dose-limiting toxicity also when applied long-term, ibrutinib is well suited in this patient population as a maintenance therapy. Therefore, the combination treatment of the trial is followed by a maintenance therapy part for patients that had no disease progression. New treatment options should control the disease as best and long as possible.
Treatment
Treatment consists of 6 cycles of 21 days each of ibrutinib in combination with bortezomib, followed by a maintenance therapy with ibrutinib monotherapy. In the maintenance therapy courses repeat every 28-days in the absence of disease progression or unacceptable toxicity.
Objectives Phase I The primary object of the trial is to establish the recommended phase II dose (RP2D) of ibrutinib in combination with bortezomib in patients with relapsed or refractory MCL.
The secondary objectives are
- to determine the safety and tolerability of ibrutinib in combination with bortezomib and
- to assess the preliminary antitumor activity of ibrutinib in combination with bortezomib Phase II The main object of the trial is to define the efficacy of the combination treatment of ibrutinib with bortezomib in patients with relapsed or refractory MCL.
The secondary objectives are
- to determine the safety and tolerability of the RP2D and
- to assess the efficacy of ibrutinib in combination with bortezomib in patients with relapsed MCL followed by an ibrutinib maintenance therapy.
- Conditions
- Mantle Cell Lymphoma
- Being tested
- Ibrutinib, bortezomib
- Keywords
- Mantle cell lymphoma, Relapsed, Refractory, Cancer, Lymphoma, Ibrutinib Imbruvica, Bortezomib Velcade
- Medical subject headings
- Lymphoma, Mantle-Cell, Recurrence, Neoplasms, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbrutinibDrug
Also called Imbruvica
Combination therapy:
Trial treatment of ibrutinib in combination with bortezomib Cycles 1-6 (1 cycle = 21 days) Ibrutinib: p.o daily; Phase I: according to DL; Phase II: RP2D established in phase I
Maintenance therapy:
p.o daily: 560 mg
bortezomibDrug
Also called Velcade®
Combination therapy:
Trial treatment of ibrutinib in combination with bortezomib Cycles 1-6 (1 cycle = 21 days) Injection of Bortezomib (s.c.), dose of 1.3 mg/m2 on day 1, 4, 8, 11
| Study group | Role | What they receive |
|---|---|---|
| Ibrutinib & Bortezomib | Experimental | Combination therapy (trial treatment of ibrutinib in combination with bortezomib) followed by ibrutinib maintenance therapy Receives: Drug: Ibrutinib; Drug: bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Dose limiting toxicity (DLT) observed during the first cycle of trial treatment
DLTs are defined based on adverse events observed in cycle 1 that are possibly, probably or definitively related to ibrutinib and/or bortezomib.
Measured: At day 8, 14, 21 during cycle 1 (1 cycle = 21 days)
Phase II: Overall response (OR) (combination therapy)
OR is defined as the proportion of patients whose best overall response, is either complete response (CR), complete response unconfirmed (CRu) or partial response (PR) according to the International Working group criteria for NHL. The primary endpoint of phase II is OR observed during the combination therapy.
Measured: 4 1/2 months after registration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2015 (estimated)
- Study start31 Aug 2015
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Why it stopped: SAKK Board decision of 14th November 2020 due to financial reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mantle Cell LymphomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- European Mantle Cell Lymphoma Network
- Responsible party
- Sponsor
- Investigators
- Urban Novak, PD Dr. med., Study chair, University Hospital Bern - Inselspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02356458
- Sponsor's protocol ID
- SAKK 36/13
- Other IDs
- 2014-003893-17, SNCTP000001235, 2014
- Status last verified
- Feb 2022
- First submitted
- 2 Feb 2015
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Novak U, Fehr M, Schar S, Dreyling M, Schmidt C, Derenzini E, Zander T, Hess G, Mey U, Ferrero S, Mach N, Boccomini C, Bottcher S, Voegeli M, Cairoli A, Ivanova VS, Menter T, Dirnhofer S, Scheibe B, Gadient S, Eckhardt K, Zucca E, Driessen C, Renner C. Combined therapy with ibrutinib and bortezomib followed by ibrutinib maintenance in relapsed or refractory mantle cell lymphoma and high-risk features: a phase 1/2 trial of the European MCL network (SAKK 36/13). EClinicalMedicine. 2023 Sep 22;64:102221. doi: 10.1016/j.eclinm.2023.102221. eCollection 2023 Oct.
PubMed 37781158
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Ibrutinib and Bortezomib Followed by Ibrutinib Maintenance to Treat Patients With Relapsed and Refractory Mantle Cell Lymphoma; a Multicenter Phase I/II Trial.
- ClinicalTrials.gov ID
- NCT02356458
- Acronym / sponsor ID
- SAKK 36/13
- Conditions
- Mantle Cell Lymphoma
- Keywords
- Mantle cell lymphoma, Relapsed, Refractory, Cancer, Lymphoma, Ibrutinib Imbruvica, Bortezomib Velcade
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: SAKK Board decision of 14th November 2020 due to financial reasons.
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Swiss Cancer InstituteUniversity, hospital or other
- Collaborators
- European Mantle Cell Lymphoma Network
- Study start
- 31 Aug 2015 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 5 Feb 2015 (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.
Mantle cell lymphoma (MCL) remains an incurable disease with frequent relapses and no standard therapeutic options in case of relapse. Prolongation of remissions or induction of longer remissions is therefore crucial. Recently, a synergistic increase in the proteasomal inhibition of ibrutinib in both bortezomib-sensitive and refractory MCL cells was shown. These findings, along with the reported single agent activities of both drugs and the non-overlapping toxicities, are the rationale to combine ibrutinib and bortezomib in MCL in this trial
Detailed description
Disease background, therapy background and aim
Mantle cell lymphoma (MCL) is a distinct subtype of B-cell lymphoma. It represents ~5% of all lymphomas and typically is present in advanced stages, a median age of 60-65 years and a dismal prognosis with a median survival of ~3 years. Currently, it remains incurable, as the patients will relapse after first line treatment and require subsequent therapy. The disease-free survival is progressively shorter with each subsequent relapse.
Currently, there is no standard therapy for relapsed MCL patients. MCL is predominantly a disease of the elderly who are not suitable for aggressive chemotherapy. Allogeneic transplants are preferred in young and fit patients, whereas (preferably single agent) chemotherapy is used to treat older patients, but usually with short duration of responses. Recently, the therapeutic armamentarium has been expanded with the availability of novel agents targeting crucial and deregulated pathways in MCL. These include the Bruton's Kinase (BTK) inhibitor ibrutinib with excellent single agent activities. New therapeutic options in the targeted patient population are clearly needed to prolong remissions especially for elderly patients where aggressive chemotherapy and allogeneic transplants are no suitable treatment options. Recently, a synergistic increase in the proteasomal inhibition of ibrutinib in both bortezomib-sensitive and refractory MCL cells was shown.
This trial is targeting patients with diagnosis of refractory or relapsed MCL disease after pretreatment with ≤2 lines of non-bortezomib-containing chemotherapy. The proposed treatment of ibrutinib in combination with bortezomib might lead to an improvement of the therapy in the targeted relapsed/refractory patient population. Given the absence of a dose-limiting toxicity also when applied long-term, ibrutinib is well suited in this patient population as a maintenance therapy. Therefore, the combination treatment of the trial is followed by a maintenance therapy part for patients that had no disease progression. New treatment options should control the disease as best and long as possible.
Treatment
Treatment consists of 6 cycles of 21 days each of ibrutinib in combination with bortezomib, followed by a maintenance therapy with ibrutinib monotherapy. In the maintenance therapy courses repeat every 28-days in the absence of disease progression or unacceptable toxicity.
Objectives Phase I The primary object of the trial is to establish the recommended phase II dose (RP2D) of ibrutinib in combination with bortezomib in patients with relapsed or refractory MCL.
The secondary objectives are
- to determine the safety and tolerability of ibrutinib in combination with bortezomib and
- to assess the preliminary antitumor activity of ibrutinib in combination with bortezomib Phase II The main object of the trial is to define the efficacy of the combination treatment of ibrutinib with bortezomib in patients with relapsed or refractory MCL.
The secondary objectives are
- to determine the safety and tolerability of the RP2D and
- to assess the efficacy of ibrutinib in combination with bortezomib in patients with relapsed MCL followed by an ibrutinib maintenance therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ibrutinib & Bortezomib | Experimental | Drug: Ibrutinib, Drug: bortezomibCombination therapy (trial treatment of ibrutinib in combination with bortezomib) followed by ibrutinib maintenance therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patient must give written informed consent before registration indicating that the patient understands the purpose of the procedures required for the trial and is willing to participate in the trial.
- Histologically confirmed mantle cell lymphoma with either overexpression of cyclin D1 protein or evidence of t(11;14)(q13;q32) assessed by cytogenetics, by fluorescence, in situ hybridization (FISH) or by polymerase chain reaction (PCR).
- Refractory or relapsed disease in need of systemic therapy after pretreatment with non-bortezomib-containing chemotherapy (including high-dose therapy)
- At least one measurable lesion ≥11 mm in its greatest transverse diameter measured with CT scan (contrast enhanced) or MRI (in case of the disease cannot be adequately imaged using CT and if contrast is not appropriate for patients according to the treating physician)
- WHO performance status 0-2
Key exclusion criteria (26 listed)
- Prior therapy with ibrutinib or bortezomib
- Adverse event neuropathy of prior therapy grade ≥2 (according to CTCAE criteria) at registration
- Previous malignancy within 5 years with the exception of adequately treated in situ cervical cancer or localized non-melanoma skin cancer.
- Presence or history of CNS disease (either CNS lymphoma or lymphomatous meningeosis)
- Evidence of ongoing systemic infections of all kind
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 |
|---|---|---|
| IbrutinibAlso: ImbruvicaCombination therapy: Trial treatment of ibrutinib in combination with bortezomib Cycles 1-6 (1 cycle = 21 days) Ibrutinib: p.o daily; Phase I: according to DL; Phase II: RP2D established in phase I Maintenance therapy: p.o daily: 560 mg | Drug | Ibrutinib & Bortezomib |
| bortezomibAlso: Velcade®Combination therapy: Trial treatment of ibrutinib in combination with bortezomib Cycles 1-6 (1 cycle = 21 days) Injection of Bortezomib (s.c.), dose of 1.3 mg/m2 on day 1, 4, 8, 11 | Drug | Ibrutinib & Bortezomib |
Primary outcome
Phase I: Dose limiting toxicity (DLT) observed during the first cycle of trial treatment
Time frame: At day 8, 14, 21 during cycle 1 (1 cycle = 21 days)
DLTs are defined based on adverse events observed in cycle 1 that are possibly, probably or definitively related to ibrutinib and/or bortezomib.
Phase II: Overall response (OR) (combination therapy)
Time frame: 4 1/2 months after registration.
OR is defined as the proportion of patients whose best overall response, is either complete response (CR), complete response unconfirmed (CRu) or partial response (PR) according to the International Working group criteria for NHL. The primary endpoint of phase II is OR observed during the combination therapy.
Results and safety
The study was stopped early (reason given: SAKK Board decision of 14th November 2020 due to financial reasons.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Derived from this study: PubMed 37781158Novak U, Fehr M, Schar S, Dreyling M, Schmidt C, Derenzini E, Zander T, Hess G, Mey U, Ferrero S, Mach N, Boccomini C, Bottcher S, Voegeli M, Cairoli A, Ivanova VS, Menter T, Dirnhofer S, Scheibe B, Gadient S, Eckhardt K, Zucca E, Driessen C, Renner C. Combined therapy with ibrutinib and bortezomib followed by ibrutinib maintenance in relapsed or refractory mantle cell lymphoma and high-risk features: a phase 1/2 trial of the European MCL network (SAKK 36/13). EClinicalMedicine. 2023 Sep 22;64:102221. doi: 10.1016/j.eclinm.2023.102221. eCollection 2023 Oct.
- 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. This study is not recruiting at the moment.
Urban Novak, PD Dr. med. study chair
University Hospital Bern - Inselspital
19 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ibrutinib and bortezomib in people with Mantle Cell Lymphoma, run by Swiss Cancer Institute at 19 sites in 3 countries.
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 18 inclusion and 26 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: stopped early, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Switzerland, Germany, Italy. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: SAKK Board decision of 14th November 2020 due to financial reasons.). Results are not available in the source record.
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?
Phase I: Dose limiting toxicity (DLT) observed during the first cycle of trial treatment (time frame: At day 8, 14, 21 during cycle 1 (1 cycle = 21 days)). The study lists 2 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 NCT02356458, which also lists 1 linked publication.
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 11 Mar 2022.