Status:
COMPLETED
Safety, Pharmacodynamics (PD), Pharmacokinetics (PK) Study of SHP141 in 1A, 1B, or 2A Cutaneous T-Cell Lymphoma (CTCL)
Lead Sponsor:
TetraLogic Pharmaceuticals
Collaborating Sponsors:
The Leukemia and Lymphoma Society
Therapeutics, Inc.
Conditions:
Lymphoma, T-Cell, Cutaneous
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 w...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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%
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01433731
Start Date
November 1 2011
End Date
September 1 2013
Last Update
March 24 2016
Active Locations (6)
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1
Stanford University
Stanford, California, United States, 94305
2
Northwestern University Dept of Dermatology
Chicago, Illinois, United States, 60611
3
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
4
Cleveland Clinic
Cleveland, Ohio, United States, 44195