Overview

This trial is active, not recruiting.

Condition hodgkin's lymphoma
Treatment tgr-1202 + brentuximab vedotin
Phase phase 1
Targets PI3K, CD30
Sponsor TG Therapeutics, Inc.
Start date June 2014
End date December 2016
Trial size 14 participants
Trial identifier NCT02164006, TGR-BV-107

Summary

The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in combination with brentuximab vedotin in patients with hodgkin's lymphoma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
TGR-1202 oral daily dose in combination with a fixed IV infusion of brentuximab vedotin
tgr-1202 + brentuximab vedotin brentuximab vedotin: Adcetris
TGR-1202 an oral daily dose with an IV infusion of brentuximab vedotin

Primary Outcomes

Measure
Maximum Tolerated Dose acceptable for participants
time frame: 21 days (1 cycle of therapy)

Secondary Outcomes

Measure
Overall Response Rate
time frame: Up to 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Confirmed diagnosis of Hodgkin's Lymphoma - Relapsed or refractory after an autologous stem cell transplant (ASCT) or at least two prior multi-agent chemotherapy regimens in patients not candidates for ASCT - Eastern Cooperative Oncology Group (ECOG) score of 0 to 2 Exclusion Criteria: - Any major surgery, chemotherapy or immunotherapy within the last 21 days - Known hepatitis B virus, hepatitis C virus or HIV infection - Autologous hematologic stem cell transplant within 3 months of study entry. Patients who had prior Allogeneic hematologic stem cell transplant are excluded

Additional Information

Official title A Multi-center Phase I/Ib Study Evaluating the Efficacy and Safety of Brentuximab Vedotin in Combination With TGR-1202, a Novel PI3K Delta Inhibitor, in Patients With Hodgkins Lymphoma
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by TG Therapeutics, Inc..