Efficacy, Safety and Tolerability Study of SHAPE in IA, IB or IIA Cutaneous T-cell Lymphoma
NCT ID: NCT02213861
Last Updated: 2016-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2014-11-30
2016-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1.0% SHAPE Gelled Solution once daily
SHAPE
topical gel
0.5% SHAPE Gelled Solution twice daily
SHAPE
topical gel
1.0% SHAPE Gelled Solution twice daily
SHAPE
topical gel
Interventions
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SHAPE
topical gel
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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TetraLogic Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Stanford Cancer Center
Stanford, California, United States
Northwestern Medical Group
Chicago, Illinois, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
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References
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Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.
Other Identifiers
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SHP-141-003
Identifier Type: -
Identifier Source: org_study_id
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