Trials / Terminated
TerminatedNCT02455297
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
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2015-08-24
- Primary completion
- 2016-04-08
- Completion
- 2016-08-31
- First posted
- 2015-05-27
- Last updated
- 2017-10-02
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02455297. Inclusion in this directory is not an endorsement.