Clinical Trial: Safety, Pharmacodynamics (PD), Pharmacokinetics (PK) Study of SHP141 in 1A, 1B, or 2A Cutaneous T-Cell Lymphoma (CTCL)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Phase 1b Study to Assess the Safety, Pharmacodynamics and Pharmacokinetics of SHP 141, A Histone Deacetylase Inhibitor, Administered Top
Brief Summary: The purpose of this study is to investigate the safety and tolerability of topical SHP141 applied directly to skin lesions in patients with Stage IA, IB, or IIA Cutaneous T-cell Lymphoma. This study will also investigate the effect of SHP141 on skin lesions in patients with Stage IA, IB, or IIA CTCL.
Detailed Summary:
Sponsor: TetraLogic Pharmaceuticals
Current Primary Outcome: Percentage of Patients With Complete or Partial Response as Measured by Change in Lesion Severity Using CAILS (Composite Assessment of Index Lesion Severity) [ Time Frame: Weekly through day 28 (days 1, 7, 14, 21, 28) and again day 42 ]
Original Primary Outcome: Lesion severity using CAILS (Composite Assessment of Index Lesion Severity) [ Time Frame: Weekly through day 28 (days 1, 7, 14, 21, 28) and again day 42 ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: TetraLogic Pharmaceuticals
Dates:
Date Received: September 9, 2011
Date Started: November 2011
Date Completion:
Last Updated: February 23, 2016
Last Verified: January 2016