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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

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.

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : placebo for SHAPE (SHP-141)
  • drug : SHAPE (SHP-141) 1.0% BID
  • drug : SHAPE (SHP-141) 0.5% BID
  • drug : SHAPE (SHP-141) 0.1% BID

Phase: Phase 1

Eligibility

Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

- Histopathologically confirmed CTCL; a documented verifiable biopsy report is required. - Documented clinical Stage IA, IB, or IIA CTCL. - Skin lesion involvement of at least 3% of BSA accessible for topical application of study drug and biopsy. - ECOG performance status of 0-2.

External Links

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Contact information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

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