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

Trial ID or NCT#

NCT02213861

Status

not recruiting iconNOT RECRUITING

Purpose

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).

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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
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Investigator(s)

Sunil Arani Reddy
Sunil Arani Reddy
Medical oncologist, Cutaneous oncology specialist
Clinical Associate Professor, Medicine - Oncology

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Contact

CCO
650-498-7061

View on ClinicalTrials.gov