Novel PI3K Delta Inhibitor TGR-1202, in Combination With Brentuximab Vedotin for Hodgkin's Lymphoma Patients
Phase 1
Completed
- Conditions
- Hodgkin's Lymphoma
- Interventions
- Drug: TGR-1202 + brentuximab vedotin
- Registration Number
- NCT02164006
- Lead Sponsor
- TG Therapeutics, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TGR-1202 + brentuximab vedotin TGR-1202 + brentuximab vedotin TGR-1202 oral daily dose in combination with a fixed IV infusion of brentuximab vedotin
- Primary Outcome Measures
Name Time Method Maximum Tolerated Dose acceptable for participants 21 days (1 cycle of therapy) To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities
- Secondary Outcome Measures
Name Time Method Overall Response Rate Up to 1 year To assess the overall response rate (ORR) of TGR-1202 in combination with brentuximab vedotin in patients with Hodgkin's lymphoma
Trial Locations
- Locations (1)
TG Therapeutics Investigational Trial Site
🇺🇸Detroit, Michigan, United States