Carfilzomib and TGR-1202 in Treatment of R/R Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02867618|
Recruitment Status : Recruiting
First Posted : August 16, 2016
Last Update Posted : January 18, 2020
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 2020|
|Estimated Study Completion Date :||October 2020|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|