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

Lymphoma, T-Cell, Cutaneous Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01433731
• Other study ID #: SHP-141-001
• Status: Completed
• Phase: Phase 1
• First received: September 9, 2011
• Last updated: August 7, 2014
• Start date: November 2011
• Est. completion date: September 2013

Study information

• Verified date: August 2014
• Source: TetraLogic Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Exclusion Criteria:

• CTCL with histologic evidence of folliculotropic variant or large cell transformed CTCL.

• Severe pruritus requiring systemic or topical treatment.

• Palpable lymph node =1.5 cm in diameter (unless the lymph node has been biopsied and has been designated as Stage IA-IIA disease).

• Coexistent second malignancy or history of prior solid organ malignancy within previous 5 years (excluding basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix (CIN 3), papillary or follicular thyroid cancer that has been treated curatively, or prostate cancer that has been treated curatively).

• Any prior history of a hematologic malignancy (other than CTCL).

• History of or current major renal, hepatic, gastrointestinal, pulmonary, cardiovascular, genito-urinary or hematological disease, CNS disorders, infectious disease or coagulation disorders as determined by the Investigator.

• Evidence of active Hepatitis B or C or HIV.

• Circulating atypical cells >5%

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous

Intervention

Drug:
• SHAPE (SHP-141)
topical gel
• placebo for SHAPE (SHP-141)
topical gel

Locations

Country	Name	City	State
United States	Northwestern University Dept of Dermatology	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	Ohio State University	Gahanna	Ohio
United States	MD Anderson Cancer Center	Houston	Texas
United States	Stanford University	Stanford	California

Sponsors (5)

Lead Sponsor	Collaborator
TetraLogic Pharmaceuticals	PPD, The Leukemia and Lymphoma Society, Therapeutics, Inc., Veristat, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lesion severity using CAILS (Composite Assessment of Index Lesion Severity)		Weekly through day 28 (days 1, 7, 14, 21, 28) and again day 42	Yes