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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
TetraLogic Pharmaceuticals

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Cutaneous T-Cell Lymphoma (CTCL) Drug: SHAPE Phase 2

Detailed Description:
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.
Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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). ]

Secondary Outcome Measures :
  1. 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). ]
  2. 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). ]
  3. Skindex-29 Quality of Life Tool [ Time Frame: Every 4 weeks for 26 weeks ]
  4. 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). ]

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

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
TetraLogic Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by TetraLogic Pharmaceuticals:
CTCL
Cutaneous T-Cell Lymphoma
Early-stage
SHAPE
SHP-141
 topical
Histone deacetylase inhibitor
CAILS
mSWAT
mycosis fungoides
Additional relevant MeSH terms:
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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