Overview

This trial is active, not recruiting.

Condition cutaneous t-cell lymphoma (ctcl)
Treatment shape
Phase phase 2
Sponsor TetraLogic Pharmaceuticals
Start date November 2014
End date October 2016
Trial size 60 participants
Trial identifier NCT02213861, SHP-141-003

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
shape SHP-141
topical gel
(Experimental)
shape SHP-141
topical gel
(Experimental)
shape SHP-141
topical gel

Primary Outcomes

Measure
Lesion severity using CAILS (Composite Assessment of Index Lesion Severity)
time frame: Every 4 weeks for 26 weeks and every 4 weeks thereafter for patients who continue on study (up to 52 weeks).

Secondary Outcomes

Measure
modified Severity Weighted Assessment Tool (mSWAT)
time frame: Every 4 weeks for 26 weeks and every 4 weeks therafter for patients who continue on study (up to 52 weeks).
Patient assessment of pruritis using a Visual Analog Scale (VAS)
time frame: Every 4 weeks for 26 weeks and every 4 weeks thereafter for patients who continue on study (up to 52 weeks).
Skindex-29 Quality of Life Tool
time frame: Every 4 weeks for 26 weeks
modified Composite Assessment of Index Lesion Severity (CAILS)
time frame: Every 4 weeks for 26 weeks and every 4 weeks therafter for patients who continue on study (up to 52 weeks).

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by TetraLogic Pharmaceuticals.