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

• Status: Unknown status
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TetraLogic Pharmaceuticals
• Treatments: Histone Deacetylase Inhibitors

Criteria

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