Clinical Trial:

Phase I/II Study of Carfilzomib and a PI3K Delta Inhibitor TGR-1202 for the Treatment of Patients with Relapsed or Refractory Lymphoma

This is an open label, phase I/II, dose-escalation study in the initial phase I followed by a phase II.

The purpose of this research study is to assess the safety and efficacy (capacity for beneficial change or therapeutic effect) of the study drug, TGR-1202 in combination with Carfilzomib.

TGR-1202 is given by mouth (orally) and in experiments when given to research subjects research subjects with lymphoid malignancies has been well tolerated and was shown to be safe. TGR-1202 is an experimental drug that has been shown to stop the growth and metabolism of tumors. Carfilzomib is an FDA approved drug used to treat people who have multiple myeloma.
Carfilzomib is similar to a drug called bortezomib that is used to treat lymphoma.  Carfilzomib is given intravenously (in your vein). 

 

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.