Clinical Trial: Study Evaluating Two Dose Levels of Targretin Capsules in Patients With Refractory Cutaneous T-cell Lymphoma (CTCL)

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

Official Title: Phase IV Randomized Study Of Two Dose Levels Of Targretin~ Capsules In Patients With Refractory Cutaneous T-Cell Lymphoma

Brief Summary: This is a multicenter, randomized, open-label, Phase IV study to assess the efficacy, tolerability and safety of two initial dose levels of bexarotene capsules in patients with refractory cutaneous T-cell lymphoma (CTCL).

Detailed Summary:
Sponsor: Valeant Pharmaceuticals International, Inc.

Current Primary Outcome: Tumor responses (clinical complete and partial): Composite Assessment of Index Lesion Disease Severity (CA); Physician's Global Assessment of Clinical Condition (PGA); Percent Body Surface Area Involvement (BSA) [ Time Frame: 24 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Time to cutaneous tumor response; Response duration; Time to cutaneous tumor progression [ Time Frame: 24 weeks ]

Original Secondary Outcome: Same as current

Information By: Valeant Pharmaceuticals International, Inc.

Dates:
Date Received: November 3, 2009
Date Started: December 2009
Date Completion:
Last Updated: June 1, 2015
Last Verified: June 2015