Efficacy, Safety and Tolerability Study of SHAPE in IA, IB or IIA Cutaneous T-cell Lymphoma
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ClinicalTrials.gov Identifier: NCT02213861 |
Recruitment Status : Unknown
Verified October 2016 by TetraLogic Pharmaceuticals.
Recruitment status was: Active, not recruiting
First Posted : August 12, 2014
Last Update Posted : October 20, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cutaneous T-Cell Lymphoma (CTCL) | Drug: SHAPE | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | November 2014 |
Estimated Primary Completion Date : | October 2016 |
Estimated Study Completion Date : | October 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: 1.0% SHAPE Gelled Solution once daily |
Drug: SHAPE
topical gel
Other Name: SHP-141 |
Experimental: 0.5% SHAPE Gelled Solution twice daily |
Drug: SHAPE
topical gel
Other Name: SHP-141 |
Experimental: 1.0% SHAPE Gelled Solution twice daily |
Drug: SHAPE
topical gel
Other Name: SHP-141 |
- Lesion severity using CAILS (Composite Assessment of Index Lesion Severity) [ Time Frame: Every 4 weeks for 26 weeks and every 4 weeks thereafter for patients who continue on study (up to 52 weeks). ]
- modified Severity Weighted Assessment Tool (mSWAT) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Every 4 weeks for 26 weeks ]
- modified Composite Assessment of Index Lesion Severity (CAILS) [ Time Frame: Every 4 weeks for 26 weeks and every 4 weeks therafter for patients who continue on study (up to 52 weeks). ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213861
United States, California | |
Stanford Cancer Center | |
Stanford, California, United States, 94305 | |
United States, Illinois | |
Northwestern Medical Group | |
Chicago, Illinois, United States, 60611 | |
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02215 | |
United States, Ohio | |
The Ohio State University Wexner Medical Center | |
Columbus, Ohio, United States, 43210 | |
United States, Texas | |
The University of Texas MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Responsible Party: | TetraLogic Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT02213861 |
Other Study ID Numbers: |
SHP-141-003 |
First Posted: | August 12, 2014 Key Record Dates |
Last Update Posted: | October 20, 2016 |
Last Verified: | October 2016 |
CTCL Cutaneous T-Cell Lymphoma Early-stage SHAPE SHP-141 |
topical Histone deacetylase inhibitor CAILS mSWAT mycosis fungoides |
Lymphoma Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |