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Phase IIa Study of Copanlisib in Relapsed or Refractory Mantle Cell Lymphoma (MCL)

NCT02455297 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2017-10-02

No results posted yet for this study

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.

Conditions

  • Lymphoma, Mantle-Cell

Interventions

DRUG

Copanlisib (BAY80-6946)

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.

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-24
Primary Completion
2016-04-08
Completion
2016-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02455297 on ClinicalTrials.gov