Phase IIa Study of Copanlisib in Relapsed or Refractory Mantle Cell Lymphoma (MCL)
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
1 other identifier
interventional
4
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2015
Shorter than P25 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2015
CompletedFirst Posted
Study publicly available on registry
May 27, 2015
CompletedStudy Start
First participant enrolled
August 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 8, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2016
CompletedOctober 2, 2017
September 1, 2017
8 months
May 23, 2015
September 29, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Objective response rate (ORR)
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.
24 weeks
Secondary Outcomes (6)
Complete response rate (CRR)
24 weeks
Disease control rate (DCR)
24 weeks
Progression-free survival (PFS)
24 weeks
Duration of response (DOR)
24 weeks
Overall survival (OS)
24 weeks
- +1 more secondary outcomes
Study Arms (1)
Copanlisib
EXPERIMENTALCopanlisib (BAY80-6946) solution for IV infusion
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (5)
Unknown Facility
Baltimore, Maryland, 21287, United States
Unknown Facility
Hackensack, New Jersey, 07601, United States
Unknown Facility
New York, New York, 10021, United States
Unknown Facility
New York, New York, 10029, United States
Unknown Facility
Burlington, Vermont, 05401, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2015
First Posted
May 27, 2015
Study Start
August 24, 2015
Primary Completion
April 8, 2016
Study Completion
August 31, 2016
Last Updated
October 2, 2017
Record last verified: 2017-09