NCT02164006 (Clinical Trial/ Brentuximab vedotin/ SGN-035)

Study Title
Novel PI3K Delta Inhibitor TGR-1202, in Combination With Brentuximab Vedotin for Hodgkin’s Lymphoma Patients (NCT02164006)

Trial Description
The purpose of this study is to evaluate the safety and effectiveness of the orally available PI3K delta (PI3Kδ) inhibitor TGR-1202 (formerly known as RP5264) in combination with the anti-CD30 antibody-drug conjugate or ADC brentuximab vedotin in patients with Hodgkin lymphoma.

TGR-1202 targets the delta isoform with nanomolar potency and several fold selectivity over the alpha, beta, and gamma isoforms of PI3K. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B-cell lymphocytes. To date, inhibition of PI3K delta signaling with TGR-1202 has demonstrated robust activity in numerous pre-clinical models and primary cells from patients with hematologic malignancies.

Combination therapies aimed at enhancing the anti-tumor activity of brentuximab vedotin and reducing its side effects may offer a significant clinical impact in the treatment of relapsed/refractory Hodgkin lymphoma.

This trial is sponsored by TG Therapeutics. [1]

Study Data

  • Condition: Lymphoma
  • Interventions:
  • Phase: I
  • Estimated Enrollment: 14
  • Start: June 2014
  • Estimated Completion: March 2016
  • Last verified: February 2016

Study Schematic 

NCT02164006 Clinical Trial

Last Editorial review: July 16, 2016
Information based on (NIH/NCI) and other sources.

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