Safety, Pharmacodynamics (PD), Pharmacokinetics (PK) Study of SHP141 in 1A, 1B, or 2A Cutaneous T-Cell Lymphoma (CTCL)

Completed · Phase 1 · Has a placebo group

Conditions studied: Lymphoma, T-Cell, Cutaneous

In brief

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.

Key facts

Study ID

NCT01433731

Run by

TetraLogic Pharmaceuticals

People needed

18

Starts

2011-11-01

Expected to finish

2013-09-01

Last updated by the study team

2016-03-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• CTCL with histologic evidence of folliculotropic variant or large cell transformed CTCL.
• 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%

Where it is running

• Stanford University — Stanford, California, United States
• Northwestern University Dept of Dermatology — Chicago, Illinois, United States
• University Hospitals Case Medical Center — Cleveland, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Ohio State University — Gahanna, Ohio, United States
• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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