Efficacy, Safety and Tolerability Study of SHAPE in IA, IB or IIA Cutaneous T-cell Lymphoma

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy, safety and tolerability of SHAPE administered topically to skin lesions in patients with early-stage cutaneous T-cell lymphoma (CTCL).

Detailed Description
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This is a Phase 2, multicenter, open-label, randomized study to evaluate the efficacy and safety of SHAPE Gelled Solution applied topically daily or twice daily for 26 consecutive weeks to specified skin lesions in patients with Stage IA, IB or IIA CTCL. Patients responding to treatment will be allowed to continue on study for a maximum of 52 weeks.

Official Title
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A Randomized Phase 2 Study to Evaluate Three Treatment Regimens of SHAPE, a Histone Deacetylase Inhibitor, in Patients With Stage IA, IB or IIA Cutaneous T-Cell Lymphoma

Conditions
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Cutaneous T-Cell Lymphoma (CTCL)

Intervention / Treatment
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* Drug: SHAPE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological confirmation of CTCL; a documented verifiable biopsy report is required 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: CTCL with histologic evidence of folliculotropic variant or large cell transformed CTCL 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1.0% SHAPE Gelled Solution once daily<br> | Drug: SHAPE<br>* topical gel<br>* Other names: SHP-141;|
| Experimental: 0.5% SHAPE Gelled Solution twice daily<br> | Drug: SHAPE<br>* topical gel<br>* Other names: SHP-141;|
| Experimental: 1.0% SHAPE Gelled Solution twice daily<br> | Drug: SHAPE<br>* topical gel<br>* Other names: SHP-141;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesion severity using CAILS (Composite Assessment of Index Lesion Severity) |  | Every 4 weeks for 26 weeks and every 4 weeks thereafter for patients who continue on study (up to 52 weeks). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified Severity Weighted Assessment Tool (mSWAT) |  | Every 4 weeks for 26 weeks and every 4 weeks therafter for patients who continue on study (up to 52 weeks). | 
| Patient assessment of pruritis using a Visual Analog Scale (VAS) |  | Every 4 weeks for 26 weeks and every 4 weeks thereafter for patients who continue on study (up to 52 weeks). | 
| Skindex-29 Quality of Life Tool |  | Every 4 weeks for 26 weeks | 
| modified Composite Assessment of Index Lesion Severity (CAILS) |  | Every 4 weeks for 26 weeks and every 4 weeks therafter for patients who continue on study (up to 52 weeks). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CTCL, Cutaneous T-Cell Lymphoma, Early-stage, SHAPE, SHP-141, topical, Histone deacetylase inhibitor, CAILS, mSWAT, mycosis fungoides