Novel PI3K Delta Inhibitor TGR-1202, in Combination With Brentuximab Vedotin for Hodgkin’s Lymphoma Patients

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2016

Interventions

  • Drug: TGR-1202 + brentuximab vedotin
    • TGR-1202 an oral daily dose with an IV infusion of brentuximab vedotin

Arms, Groups and Cohorts

  • Experimental: TGR-1202 + brentuximab vedotin
    • TGR-1202 oral daily dose in combination with a fixed IV infusion of brentuximab vedotin

Clinical Trial Outcome Measures

Primary Measures

  • Maximum Tolerated Dose acceptable for participants
    • Time Frame: 21 days (1 cycle of therapy)
    • To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities

Secondary Measures

  • Overall Response Rate
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • TG Therapeutics, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor

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