Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Lymphoma, T-Cell, Cutaneous

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Peripheral T-cell Lymphoma

Cutaneous T-cell Lymphoma

Pharmaceutical Solutions

All Drugs and Chemicals

Histone Deacetylase Inhibitors

placebo for SHAPE (SHHP-141) topical gelled solution

SHAPE (SHP-141) topical gelled solution at 0.1% concentration twice weekly

SHAPE (SHP-141) topical gelled solution at 0.5% concentration twice weekly

SHAPE (SHP-141) topical gelled solution at 1.0% concentration twice weekly

placebo for SHAPE (SHP-141)

SHAPE (SHP-141) 0.1% BID

SHAPE (SHP-141) 0.5% BID

SHAPE (SHP-141) 1.0% BID

Joan Guitart, MD

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.

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

Response assessed by change in lesion severity using Composite Assessment of Index Lesion Severity (CAILS) Assessment Tool which measures clinical signs of CTCL by erythema; scaling; plaque elevation; hypo- or hyperpigmentation, each on a scale of 0-8; and lesion size (cm2), on a scale of 0 (no lesion; 0 cm2) to 18 (300 cm2). Up to five index lesions are each scored, and a subtotal CAILS score is provided for each index lesion. A total score is calculated by summing these subtotals. Response criteria measure the change in CAILS score from baseline to follow-up as follows: Complete Response (CR): 100% decrease in CAILS score; Partial Response (PR): 50% - 99% decrease in CAILS score; Stable Disease (SD): \< 25% increase to \< 50% decrease in CAILS score; Progressive Disease (PD) ≥ 25% increase in CAILS score.

The Leukemia and Lymphoma Society

Therapeutics, Inc.

Veristat, Inc.

TetraLogic Pharmaceuticals

placebo for SHAPE (SHP-141): topical gelled solution

Placebo for SHAPE (SHP-141)

SHAPE (SHP-141): topical gelled solution at 0.1% concentration twice daily

SHAPE (SHP-141): topical gelled solution at 0.5% concentration twice daily

SHAPE (SHP-141): topical gelled solution at 1.0% concentration twice daily

Total

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Vice President, Clinical Research

Histone deacetylase inhibitor

SHAPE (SHP-141): topical gel

SHAPE (SHP-141)

Percentage of Patients With Complete or Partial Response as Measured by Change in Lesion Severity Using CAILS (Composite Assessment of Index Lesion Severity)

Spots Global Cancer Trial Database for Safety, Pharmacodynamics (PD), Pharmacokinetics (PK) Study of SHP141 in 1A, 1B, or 2A Cutaneous T-Cell Lymphoma (CTCL)

Trial Identification

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Interventions

Study Description

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