Clinical Trial: Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multicenter, Open-Label Trial of Belinostat in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma

Brief Summary: The purpose of this study is to assess efficacy and safety of belinostat in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), who failed at least one prior systemic therapy.

Detailed Summary:

This is an open-label, multicenter, single arm efficacy and safety study in patients with relapsed or refractory peripheral T-cell lymphoma, who have failed at least one prior systemic therapy.

Approximately 120 patients will be enrolled. Patients will be treated with 1000 mg/m² belinostat administered as a 30-minute IV infusion on days 1-5 of every 3-week cycle until there is disease progression or unmanageable treatment-related toxicities.

The primary study endpoint is objective response rate (ORR) based on the IHP revision IWG criteria. Safety will be evaluated during the study and for 30 days after the last administration of study drug. Adverse events and laboratory studies will be graded according to NCI-CTCAE v. 3.0.

Sponsor: Spectrum Pharmaceuticals, Inc

Current Primary Outcome: Primary - Objective response rate [ Time Frame: December 2010 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Safety, further efficacy parameters (e.g. time to response, duration of response, time to progression, and survival), and population pharmacokinetics [ Time Frame: December 2010 ]

Original Secondary Outcome: Same as current

Information By: Spectrum Pharmaceuticals, Inc

Dates:
Date Received: March 19, 2009
Date Started: December 2008
Date Completion:
Last Updated: December 4, 2014
Last Verified: December 2014