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

NCT01433731 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2016-03-24

Study results available
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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

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

Sponsors & Collaborators

  • The Leukemia and Lymphoma Society

    collaborator OTHER

  • Therapeutics, Inc.

    collaborator INDUSTRY

  • Veristat, Inc.

    collaborator OTHER

  • PPD Development, LP

    collaborator INDUSTRY

  • TetraLogic Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Joan Guitart, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01433731 on ClinicalTrials.gov