NCT01433731

Safety, Pharmacodynamics (PD), Pharmacokinetics (PK) Study of SHP141 in 1A, 1B, or 2A Cutaneous T-Cell Lymphoma (CTCL)

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 Topically Up to 28 Days to Patients With Stage IA, IB or IIA Cutaneous T-Cell Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: TetraLogic Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoma, T-Cell, Cutaneous

Interventions

Type	Name	Description
DRUG	placebo for SHAPE (SHP-141)	topical gelled solution
DRUG	SHAPE (SHP-141) 0.1% BID	topical gelled solution
DRUG	SHAPE (SHP-141) 0.5% BID	topical gelled solution
DRUG	SHAPE (SHP-141) 1.0% BID	topical gelled solution

Timeline

• Start date: 2011-11-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2011-09-14
• Last updated: 2016-03-24
• Results posted: 2016-03-24

Locations

6 sites across 1 country: United States