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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01433731
Other study ID # SHP-141-001
Secondary ID
Status Completed
Phase Phase 1
First received September 9, 2011
Last updated August 7, 2014
Start date November 2011
Est. completion date September 2013

Study information

Verified date August 2014
Source TetraLogic Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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 will also investigate the effect of SHP141 on skin lesions in patients with Stage IA, IB, or IIA CTCL.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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 Criteria:

- 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%

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
SHAPE (SHP-141)
topical gel
placebo for SHAPE (SHP-141)
topical gel

Locations

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

Sponsors (5)

Lead Sponsor Collaborator
TetraLogic Pharmaceuticals PPD, The Leukemia and Lymphoma Society, Therapeutics, Inc., Veristat, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lesion severity using CAILS (Composite Assessment of Index Lesion Severity) Weekly through day 28 (days 1, 7, 14, 21, 28) and again day 42 Yes
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