- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02455297
Phase IIa Study of Copanlisib in Relapsed or Refractory Mantle Cell Lymphoma (MCL)
September 29, 2017 updated by: Bayer
A Single-arm, Open-label Phase IIa Study to Evaluate the Efficacy and Safety of Copanlisib Monotherapy in Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL), Who Failed Ibrutinib Treatment or Were Unable to Tolerate Ibrutinib
The primary objective of this study is to assess objective response rate (ORR) in patients with relapsed or refractory MCL who failed ibrutinib treatment or were unable to tolerate ibrutinib.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21287
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New Jersey
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Hackensack, New Jersey, United States, 07601
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New York
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New York, New York, United States, 10021
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New York, New York, United States, 10029
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Vermont
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Burlington, Vermont, United States, 05401
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically confirmed MCL
Patients who have previously received treatment with ibrutinib (modified by amendment 1), including:
- Completion of at least 1 cycle of treatment with ibrutinib and confirmed evidence of disease progression or refractoriness to treatment or
- Discontinuation of ibrutinib treatment at an earlier time due to toxicity
- Measurable disease according to the Lugano Classification
- At least 28 days or 5 half-lives, whichever is shorter, from the completion of anti-cancer treatment (including, but not limited to, immunotherapy, chemotherapy, targeted therapy and biologic therapy) to the start of study treatment, excluding ibrutinib where the window may be less and at minimum 3 days (modified by amendment 1)
- Availability of fresh tumor tissue at screening
- Male or female patients ≥ 18 years old
- ECOG (Eastern Cooperative Oncology Group) performance status of ≤ 2
- Left ventricular ejection fraction (LVEF) by echocardiogram or multiple gated acquisition (MUGA) scan ≥ the lower limit of normal (LLN) for the Institution
- Adequate bone marrow, liver and renal function
Exclusion Criteria:
- Any of the following as the only site(s) of disease: palpable lymph nodes not visible on imaging studies, skin lesions, or bone marrow involvement only
- Current central nervous system (CNS) involvement by lymphoma
- New York Heart Association (NYHA) class III or IV heart disease
- Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months). Myocardial infarction less than 6 months before start of study treatment
- Uncontrolled arterial hypertension despite optimal medical management (per investigator's assessment) (modified by amendment 1)
- Type I or II diabetes mellitus with HbA1c > 8.5% at screening (modified by amendment 1)
- Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before start of study treatment. However, if a patient has recovered to ECOG performance status of ≤ 2 he/she may be enrolled provided that other eligibility criteria are met
- Ongoing or active infection of Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 3
- Known history of human immunodeficiency virus (HIV) infection
- Acute or chronic hepatitis B (HBV) or hepatitis C (HCV) infection requiring concomitant treatment prohibited by this protocol (i.e.immunosuppressive therapy)
- History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function (as judged by the investigator)
- Prior treatment with PI3K inhibitor(s)
- Cytomegalovirus (CMV) PCR positive at baseline
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Copanlisib
Copanlisib (BAY80-6946) solution for IV infusion
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Starting dose 60 mg (dose reduction due to toxicities to 45 mg allowed).
Administered in slow IV bolus on days 1, 8 and 15 of each 28 day cycle until disease progression or until another criterion is met for withdrawal from study treatment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate (ORR)
Time Frame: 24 weeks
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ORR is defined as the proportion of patients who have a best overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano response criteria in NHL 2014.
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24 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete response rate (CRR)
Time Frame: 24 weeks
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Defined as the proportion of patients who have a best overall response of CR during study conduct according to the criteria defined by the Lugano response criteria in NHL 2014
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24 weeks
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Disease control rate (DCR)
Time Frame: 24 weeks
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Defined as the proportion of patients who have a best response of CR, PR, or stable disease (SD)
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24 weeks
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Progression-free survival (PFS)
Time Frame: 24 weeks
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Defined as the time (in days) from the date of first administration of study treatment to radiological disease progression or death from any cause (if death occurs before radiological progression is documented).
PFS for patients without radiological progression or death at the time of analysis will be censored at the last date of evaluable tumor assessment.
PFS for alive patients who have no tumor assessments after baseline will be censored at day 1.
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24 weeks
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Duration of response (DOR)
Time Frame: 24 weeks
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Defined as the time (in days) from the date of first observed tumor response of CR or PR, whichever was noted earlier, to radiological disease progression or death from any cause (if death occurs before radiological progression is documented)
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24 weeks
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Overall survival (OS)
Time Frame: 24 weeks
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Defined as the time (in days) from the date of first administration of study treatment to death from any cause.
The OS time for patients alive at the time of analysis will be censored at their last known alive date.
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24 weeks
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Number of participants with treatment emergent adverse events (TEAEs) as a measure of safety and tolerability
Time Frame: Approximately 7 months
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Approximately 7 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 24, 2015
Primary Completion (Actual)
April 8, 2016
Study Completion (Actual)
August 31, 2016
Study Registration Dates
First Submitted
May 23, 2015
First Submitted That Met QC Criteria
May 26, 2015
First Posted (Estimate)
May 27, 2015
Study Record Updates
Last Update Posted (Actual)
October 2, 2017
Last Update Submitted That Met QC Criteria
September 29, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17120
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lymphoma, Mantle-Cell
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Northwestern UniversityNational Cancer Institute (NCI); Janssen Scientific Affairs, LLCActive, not recruitingStage III Mantle Cell Lymphoma | Stage IV Mantle Cell Lymphoma | Contiguous Stage II Mantle Cell Lymphoma | Noncontiguous Stage II Mantle Cell Lymphoma | Stage I Mantle Cell LymphomaUnited States
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City of Hope Medical CenterNational Cancer Institute (NCI)CompletedRecurrent Mantle Cell Lymphoma | Stage III Mantle Cell Lymphoma | Stage IV Mantle Cell Lymphoma | Contiguous Stage II Mantle Cell Lymphoma | Noncontiguous Stage II Mantle Cell Lymphoma | Stage I Mantle Cell LymphomaUnited States
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National Cancer Institute (NCI)CompletedStage III Mantle Cell Lymphoma | Stage IV Mantle Cell Lymphoma | Contiguous Stage II Mantle Cell Lymphoma | Noncontiguous Stage II Mantle Cell Lymphoma | Stage I Mantle Cell LymphomaUnited States
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Roswell Park Cancer InstituteNational Comprehensive Cancer NetworkCompletedStage III Mantle Cell Lymphoma | Stage IV Mantle Cell Lymphoma | Stage I Mantle Cell Lymphoma | Stage II Contiguous Mantle Cell Lymphoma | Stage II Non-Contiguous Mantle Cell LymphomaUnited States
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University of WashingtonNational Cancer Institute (NCI); National Comprehensive Cancer NetworkTerminatedRecurrent Mantle Cell Lymphoma | Refractory Mantle Cell Lymphoma | Ann Arbor Stage I Mantle Cell Lymphoma | Ann Arbor Stage II Mantle Cell Lymphoma | Ann Arbor Stage III Mantle Cell Lymphoma | Ann Arbor Stage IV Mantle Cell LymphomaUnited States
-
Burzynski Research InstituteWithdrawnRecurrent Mantle Cell Lymphoma | Stage III Mantle Cell Lymphoma | Stage IV Mantle Cell Lymphoma | Contiguous Stage II Mantle Cell Lymphoma | Noncontiguous Stage II Mantle Cell LymphomaUnited States
-
BeiGeneRecruitingMantle Cell Lymphoma | Relapsed Mantle Cell Lymphoma | Refractory Mantle Cell Lymphoma (MCL)United States, China, Israel, Belgium, Poland, Spain, Turkey, Brazil, Italy, Canada, United Kingdom, France, Germany, Argentina, Puerto Rico
-
BeiGeneCompletedRefractory Mantle Cell Lymphoma | Relapsed Mantle Cell LymphomaChina
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Fondazione Italiana Linfomi - ETSRecruitingRefractory Mantle Cell Lymphoma | Relapsed Mantle Cell LymphomaItaly
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingMantle Cell Lymphoma | Blastoid Variant Mantle Cell Lymphoma | Pleomorphic Variant Mantle Cell LymphomaUnited States
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BayerCompleted
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BayerCompleted
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BayerNo longer availableCancerBrazil, Hong Kong, Hungary, Malaysia, Poland, Romania, Russian Federation, Taiwan, Ukraine, Ireland, Chile
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BayerCompleted
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BayerCompletedHepatic Insufficiency, Renal InsufficiencyGermany, Romania
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BayerCompletedAdvanced or Metastatic Solid TumorUnited States, Spain, Korea, Republic of, Belgium, Singapore, Germany
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BayerCompletedDiffuse, Large B-Cell, LymphomaBelgium, France, Canada, Korea, Republic of, Australia, Germany, United Kingdom, Italy, Denmark, Singapore