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

Bayer0 sites4 target enrollmentAugust 24, 2015

ConditionsLymphoma, Mantle-Cell

InterventionsCopanlisib (BAY80-6946)

DrugsCopanlisib (BAY80-6946)

Overview

Phase: Phase 2
Intervention: Copanlisib (BAY80-6946)
Conditions: Lymphoma, Mantle-Cell
Sponsor: Bayer
Enrollment: 4
Primary Endpoint: Objective response rate (ORR)
Status: Terminated
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 24, 2015

End Date

August 31, 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility Criteria

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

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)

Arms & Interventions

Copanlisib

Copanlisib (BAY80-6946) solution for IV infusion

Intervention: Copanlisib (BAY80-6946)

Outcomes

Primary Outcomes

Objective response rate (ORR)

Time Frame: 24 weeks

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.

Secondary Outcomes

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)
Number of participants with treatment emergent adverse events (TEAEs) as a measure of safety and tolerability(Approximately 7 months)