Efficacy, Safety and Tolerability Study of SHAPE in IA, IB or IIA Cutaneous T-cell Lymphoma
- Registration Number
- NCT02213861
- Lead Sponsor
- TetraLogic Pharmaceuticals
- Brief 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).
- Detailed 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 & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1.0% SHAPE Gelled Solution once daily SHAPE - 0.5% SHAPE Gelled Solution twice daily SHAPE - 1.0% SHAPE Gelled Solution twice daily SHAPE -
- Primary Outcome Measures
Name Time Method 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).
- Secondary Outcome Measures
Name Time Method 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). 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). Skindex-29 Quality of Life Tool Every 4 weeks for 26 weeks 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).
Trial Locations
- Locations (5)
Stanford Cancer Center
🇺🇸Stanford, California, United States
Northwestern Medical Group
🇺🇸Chicago, Illinois, United States
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States