Status:
UNKNOWN
Efficacy, Safety and Tolerability Study of SHAPE in IA, IB or IIA Cutaneous T-cell Lymphoma
Lead Sponsor:
TetraLogic Pharmaceuticals
Conditions:
Cutaneous T-Cell Lymphoma (CTCL)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2016
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02213861
Start Date
November 1 2014
End Date
October 1 2016
Last Update
October 20 2016
Active Locations (5)
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1
Stanford Cancer Center
Stanford, California, United States, 94305
2
Northwestern Medical Group
Chicago, Illinois, United States, 60611
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
4
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210