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

TetraLogic Pharmaceuticals

Status and phase

Unknown

Phase 2

Conditions

Cutaneous T-Cell Lymphoma (CTCL)

Treatments

Drug: SHAPE

Study type

Interventional

Funder types

Industry

Identifiers

NCT02213861

SHP-141-003

Details and patient eligibility

About

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).

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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