At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 18 enrolled
Drug / intervention
placebo for SHAPE (SHP-141) +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating placebo for SHAPE (SHP-141), SHAPE (SHP-141) 0.1% BID, and 2 other interventions for Lymphoma, T-Cell, Cutaneous. Completed, enrolled 18 participants across 6 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma, T-Cell, Cutaneous
CountriesUnited States
Timeline
Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 2011
Enrollment StartNov 2011
Primary CompletionSep 2013
TodayJul 2026
First PostedSep 14, 2011
Enrollment StartNov 1, 2011
Primary CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.8 years ago
Interventions
placebo for SHAPE (SHP-141)drug
topical gelled solution
SHAPE (SHP-141) 0.1% BIDdrug
topical gelled solution
SHAPE (SHP-141) 0.5% BIDdrug
topical gelled solution
SHAPE (SHP-141) 1.0% BIDdrug
topical gelled solution