Efficacy, Safety and Tolerability Study of SHAPE in IA, IB or IIA Cutaneous T-cell Lymphoma

Cutaneous T-Cell Lymphoma (CTCL) Clinical Trial

Official title:

A Randomized Phase 2 Study to Evaluate Three Treatment Regimens of SHAPE, a Histone Deacetylase Inhibitor, in Patients With Stage IA, IB or IIA Cutaneous T-Cell Lymphoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02213861
• Other study ID #: SHP-141-003
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 6, 2014
• Last updated: October 18, 2016
• Start date: November 2014
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• 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 evaluate the efficacy, safety and tolerability of SHAPE administered topically to skin lesions in patients with early-stage cutaneous T-cell lymphoma (CTCL).

Description:

This is a Phase 2, multicenter, open-label, randomized study to evaluate the efficacy and safety of SHAPE Gelled Solution applied topically daily or twice daily for 26 consecutive weeks to specified skin lesions in patients with Stage IA, IB or IIA CTCL. Patients responding to treatment will be allowed to continue on study for a maximum of 52 weeks.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histological confirmation of CTCL; a documented verifiable biopsy report is required

• Documented clinical stage IA, IB or IIA CTCL

• Skin lesion involvement of at least 2% of BSA accessible for topical application of study drug

• ECOG performance status of 0-2

Exclusion Criteria:

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

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

• Co-existent second malignancy or history of prior solid organ malignancy within previous 5 years (excluding basal or squamous cell carcinoma, in situ carcinoma of the cervix (CIN3), papillary or follicular thyroid cancer or prostate cancer that has been treated curatively

• Any prior history of hematologic malignancy (other than CTCL) within past 5 years

• CTCL disease that is known to be refractory to systemic histone deacetylase inhibitors

• Prior or concurrent central nervous system (CNS) metastases

• History of or current major gastrointestinal, pulmonary, cardiovascular, genitourinary or hematologic 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 of clinical significance

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cutaneous T-Cell Lymphoma (CTCL)
• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous

Intervention

Drug:
• SHAPE
topical gel

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Northwestern Medical Group	Chicago	Illinois
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Stanford Cancer Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
TetraLogic Pharmaceuticals

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)		Every 4 weeks for 26 weeks and every 4 weeks thereafter for patients who continue on study (up to 52 weeks).	No
Secondary	modified Severity Weighted Assessment Tool (mSWAT)		Every 4 weeks for 26 weeks and every 4 weeks therafter for patients who continue on study (up to 52 weeks).	No
Secondary	Patient assessment of pruritis using a Visual Analog Scale (VAS)		Every 4 weeks for 26 weeks and every 4 weeks thereafter for patients who continue on study (up to 52 weeks).	No
Secondary	Skindex-29 Quality of Life Tool		Every 4 weeks for 26 weeks	No
Secondary	modified Composite Assessment of Index Lesion Severity (CAILS)		Every 4 weeks for 26 weeks and every 4 weeks therafter for patients who continue on study (up to 52 weeks).	No