Carfilzomib and TGR-1202 in Treatment of R/R Lymphoma
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|ClinicalTrials.gov Identifier: NCT02867618|
Recruitment Status : Recruiting
First Posted : August 16, 2016
Last Update Posted : July 26, 2019
This is an open label, phase I/II, dose-escalation study in the initial phase I followed by a phase II.
The primary objective of the phase I is to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of the combinations of TGR-1202 and carfilzomib in participants with relapsed and refractory (R/R) non-Hodgkin lymphoma (NHL) and Hodgkin lymphoma (HL). The safety and toxicity of this combination will be evaluated throughout the entire study.
If the combination of TGR-1202 and carfilzomib is found to be feasible and an MTD is established, the phase II part of the study will be initiated.
Phase II will consist of a 2-stage design of the combination of TGR-1202 and carfilzomib for participants with R/R NHL.
|Condition or disease||Intervention/treatment||Phase|
|Hodgkin Disease Lymphoma, Non-hodgkin||Drug: Carfilzomib Drug: TGR-1202||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Carfilzomib and a PI3Kdelta Inhibitor TGR-1202 in the Treatment of Patients With Relapsed or Refractory Lymphoma|
|Actual Study Start Date :||October 16, 2016|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2019|
Experimental: Carfilzomib + TGR-1202
Oral TGR-1202 will be given PO once daily on Days 1-28 and carfilzomib given intravenously twice a week for 3 consecutive weeks, on days 1, 2, 8, 9, 15, and 16 on the 28-day cycle.
Carfilzomib given intravenously twice a week for 3 consecutive weeks, on days 1, 2, 8, 9, 15, and 16 on the 28-day cycle. This will be in combination with the oral TGR-1202
Other Name: Kyprolis
Oral TGR-1202 will be given PO once daily on Days 1-28 . This will be given in combination with the intravenous Carfilzomib
Other Name: (formerly) RP-5264
- Maximum Tolerated Dose (MTD) (Phase 1) [ Time Frame: 9 months ]The highest dose of the study treatment that does not cause unacceptable side effects.
- Objective Response Rate (ORR) (Phase 2) [ Time Frame: 9 months ]Defined as best response (complete response and partial response) by 4 cycles.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867618
|Contact: Changchun Deng, MD, PhD||(212) firstname.lastname@example.org|
|United States, New York|
|Columbia University Irving Medical Center - Center for Lymphoid Malignancies||Recruiting|
|New York, New York, United States, 10019|
|Contact: Freddy Loffredo 212-326-5720 email@example.com|
|Principal Investigator: Changchun Deng, M.D., PhD|
|Principal Investigator:||Changchun Deng, MD||Assistant Professor of Clinical Medicine and Experimental Therapeutics|