Overview

This trial is active, not recruiting.

Condition diffuse large-cell lymphoma
Treatment copanlisib (bay80-6946)
Phase phase 2
Target PI3K
Sponsor Bayer
Start date May 2015
End date July 2016
Trial size 67 participants
Trial identifier NCT02391116, 17119, 2014-004848-36

Summary

To assess the potential efficacy (in terms of objective response) of single agent copanlisib in patients with relapsed or refractory Diffuse large B-cell lymphoma (DLBCL) and assess the relationship between efficacy and a potentially predictive biomarker

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Copanlisib (BAY80-6946) solution for IV infusion (test drug/investigational medicinal product0
copanlisib (bay80-6946)
Starting dose: 60 mg (Dose reduction due to toxicities to 45 mg is allowed.), will be administered as a slow bolus IV injection on Days 1, 8 and 15 of each 28-day treatment cycle till patient disease progression is observed or patient withdraw treatment for any reason

Primary Outcomes

Measure
Objective Response
time frame: 24 weeks after the last patient fully evaluable for the primary endpoint started treatment.
Objective response in CD79B mutant patient population
time frame: 24 weeks after the last patient fully evaluable for the primary endpoint started treatment
Objective response in CD79B wild-type patient population
time frame: 24 weeks after the last patient fully evaluable for the primary endpoint started treatment.
Objective response in cell-of-origin ABC patient population
time frame: 24 weeks after the last patient fully evaluable for the primary endpoint started treatment
Objective response in cell-of-origin GCB patient population
time frame: 24 weeks after the last patient fully evaluable for the primary endpoint started treatment
Objective response in unclassifiable cell-of-origin patient population
time frame: 24 weeks after the last patient fully evaluable for the primary endpoint started treatment

Secondary Outcomes

Measure
Duration of response (DOR)
time frame: Up to 24 weeks after the last patient fully evaluable for the primary endpoint started treatment
Progression-free survival (PFS)
time frame: Up to 24 weeks after the last patient fully evaluable for the primary endpoint started treatment
Overall survival (OS)
time frame: Up to 24 weeks after the last patient fully evaluable for the primary endpoint started treatment
Disease control rate (DCR)
time frame: Up to 24 weeks after the last patient fully evaluable for the primary endpoint started treatment.
Duration of stable disease (DOSD)
time frame: Up to 24 weeks after the last patient fully evaluable for the primary endpoint started treatment
Number of participants with adverse events as a measure of safety and tolerability
time frame: Up to 24 weeks after the last patient fully evaluable for the primary endpoint started treatment

Eligibility Criteria

Male or female participants from 18 years up to 120 years old.

Inclusion Criteria: - Diagnosis of Diffuse large B-cell lymphoma (DLBCL) (de novo or DLBCL transformed from follicular lymphoma on the basis of a tissue biopsy). - Received at least one prior therapy for aggressive Non-Hodgkin's Lymphoma (NHL) (DLBCL) - Patients must have measurable disease. - ECOG (Eastern Cooperative Oncology Group) performance status (PS) ≤ 2 - Left ventricular ejection fraction (LVEF) ≥ the lower limit of normal (LLN) for the Institution (as per local standard of care) as measured by echocardiogram (ECHO) or Multiple gated acquisition (MUGA) scan - 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 - Active CTCAE (Common Terminology Criteria for Adverse Events) Grade 3/4 infection - Known history of human immunodeficiency virus (HIV) infection - Current central nervous system (CNS) involvement by lymphoma - Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months). Myocardial infarction within the past 6 months before start of study treatment - Type I or II diabetes mellitus with HbA1c > 8.5% or fasting plasma glucose > 160 mg/dL at Screening. - New York Heart Association (NYHA) class III or IV heart disease - Concurrent participation in other clinical studies. - Patients who previously received therapy with copanlisib or other PI3K inhibitors are not eligible for enrollment.

Additional Information

Official title An Open-label, Single-arm Phase II Study in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) to Evaluate Efficacy and Safety of Treatment With Single Agent Copanlisib and the Impact of Biomarkers Thereupon.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Bayer.