stop_circleTerminated/Withdrawn
Lymphoma, Mantle-Cell
Bayer Identifier:
17120
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Phase IIa study of copanlisib in relapsed or refractory mantle cell lymphoma (MCL)
Trial purpose
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.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
4Trial Dates
August 2015 - August 2016Phase
Phase 2Could I Receive a placebo
NoProducts
Aliqopa (Copanlisib, BAY80-6946)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Terminated | New York, 10021, United States | |
Terminated | New York, 10029, United States | |
Terminated | Hackensack, 07601, United States | |
Terminated | Baltimore, 21287, United States | |
Terminated | Burlington, 05401, United States |
Primary Outcome
- Objective response rate (ORR)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.date_rangeTime Frame:24 weeksenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Complete response rate (CRR)Defined as the proportion of patients who have a best overall response of CR during study conduct according to the criteria defined by the Lugano response criteria in NHL 2014date_rangeTime Frame:24 weeksenhanced_encryptionNoSafety Issue:
- Disease control rate (DCR)Defined as the proportion of patients who have a best response of CR, PR, or stable disease (SD)date_rangeTime Frame:24 weeksenhanced_encryptionNoSafety Issue:
- Progression-free survival (PFS)Defined as the time (in days) from the date of first administration of study treatment to radiological disease progression or death from any cause (if death occurs before radiological progression is documented). PFS for patients without radiological progression or death at the time of analysis will be censored at the last date of evaluable tumor assessment. PFS for alive patients who have no tumor assessments after baseline will be censored at day 1.date_rangeTime Frame:24 weeksenhanced_encryptionNoSafety Issue:
- Duration of response (DOR)Defined as the time (in days) from the date of first observed tumor response of CR or PR, whichever was noted earlier, to radiological disease progression or death from any cause (if death occurs before radiological progression is documented)date_rangeTime Frame:24 weeksenhanced_encryptionNoSafety Issue:
- Overall survival (OS)Defined as the time (in days) from the date of first administration of study treatment to death from any cause. The OS time for patients alive at the time of analysis will be censored at their last known alive date.date_rangeTime Frame:24 weeksenhanced_encryptionNoSafety Issue:
- Number of participants with treatment emergent adverse events (TEAEs) as a measure of safety and tolerabilitydate_rangeTime Frame:Approximately 7 monthsenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1