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Safety, Pharmacodynamics (PD), Pharmacokinetics (PK) Study of SHP141 in 1A, 1B, or 2A Cutaneous T-Cell Lymphoma (CTCL)
Trial ID: NCT01433731
The purpose of this study is to investigate the safety and tolerability of topical SHP141 applied directly to skin lesions in patients with Stage IA, IB, or IIA Cutaneous T-cell Lymphoma. This study will also investigate the effect of SHP141 on skin lesions in patients with Stage IA, IB, or IIA CTCL.
A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Phase 1b Study to Assess the Safety, Pharmacodynamics and Pharmacokinetics of SHP 141, A Histone Deacetylase Inhibitor, Administered Topically Up to 28 Days to Patients With Stage IA, IB or IIA Cutaneous T-Cell Lymphoma
- Histopathologically confirmed CTCL; a documented verifiable biopsy report is required.
- Documented clinical Stage IA, IB, or IIA CTCL.
- Skin lesion involvement of at least 3% of BSA accessible for topical application of
study drug and biopsy.
- ECOG performance status of 0-2.
- CTCL with histologic evidence of folliculotropic variant or large cell transformed
- Severe pruritus requiring systemic or topical treatment.
- Palpable lymph node ≥1.5 cm in diameter (unless the lymph node has been biopsied and
has been designated as Stage IA-IIA disease).
- Coexistent second malignancy or history of prior solid organ malignancy within
previous 5 years (excluding basal or squamous cell carcinoma of the skin, in situ
carcinoma of the cervix (CIN 3), papillary or follicular thyroid cancer that has been
treated curatively, or prostate cancer that has been treated curatively).
- Any prior history of a hematologic malignancy (other than CTCL).
- History of or current major renal, hepatic, gastrointestinal, pulmonary,
cardiovascular, genito-urinary or hematological 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 >5%
drug: placebo for SHAPE (SHP-141)
drug: SHAPE (SHP-141) 0.1% BID
drug: SHAPE (SHP-141) 0.5% BID
drug: SHAPE (SHP-141) 1.0% BID
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