CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 67 enrolled
Drug / intervention
Copanlisib (Aliqopa, BAY80-6946)drug
Likely dose
Copanlisib (Aliqopa, BAY80-6946) 60 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02391116
NCT02391116Phase 2Completed
CompareCT.gov

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.

Bayer·interventional·Posted Mar 18, 2015·Updated Jan 4, 2019

In Brief

A Phase 2 clinical trial evaluating Copanlisib (Aliqopa, BAY80-6946) for Diffuse, Large B-Cell, Lymphoma. Completed, enrolled 67 participants across 32 sites in 10 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiffuse, Large B-Cell, Lymphoma
CountriesAustralia, Belgium, Canada, Denmark, France, Germany, Italy, Singapore, South Korea, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 18, 2015
Enrollment StartMay 8, 2015
Primary CompletionJul 5, 2016
Study CompletionJan 19, 2018
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 11.3 years ago

Interventions

Copanlisib (Aliqopa, BAY80-6946)drug

Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment