Safety, Pharmacodynamics (PD), Pharmacokinetics (PK) Study of SHP141 in 1A, 1B, or 2A Cutaneous T-Cell Lymphoma (CTCL)
This study is currently recruiting participants.
Verified February 2012 by Shape Pharmaceuticals, Inc.
Sponsor:
Shape Pharmaceuticals, Inc.
Collaborators:
The Leukemia and Lymphoma Society
Therapeutics, Inc.
Veristat, Inc.
PPD
Information provided by (Responsible Party):
Shape Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01433731
First received: September 9, 2011
Last updated: February 6, 2012
Last verified: February 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma, T-Cell, Cutaneous |
Drug: SHP-141 Drug: placebo fo SHP-141 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Phase 1b Study to Assess the Safety, Pharmacodynamics and Pharmacokinetics of SHP 141, A Histone Deacetylase Inhibitor, Administered Topically Up to 28 Days to Patients With Stage IA, IB or IIA Cutaneous T-Cell Lymphoma |
Resource links provided by NLM:
Further study details as provided by Shape Pharmaceuticals, Inc.:
Primary Outcome Measures:
- Lesion severity using CAILS (Composite Assessment of Index Lesion Severity) [ Time Frame: Weekly through day 28 (days 1, 7, 14, 21, 28) and again day 42 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 48 |
| Study Start Date: | September 2011 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SHP-141
Histone deacetylase inhibitor
|
Drug: SHP-141
topical gel
|
| Placebo Comparator: placebo |
Drug: placebo fo SHP-141
topical gel
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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%
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01433731
Locations
| United States, California | |
| Stanford University | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Katie Turner 650-725-1202 | |
| United States, Illinois | |
| Northwestern University Dept of Dermatology | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Nazila Barahmani, MD 312-695-6786 | |
| United States, Ohio | |
| Cleveland Clinic | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Amanda Maggiotto 866-223-8100 | |
| United States, Texas | |
| MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Carol Wilson 713-563-4655 | |
Sponsors and Collaborators
Shape Pharmaceuticals, Inc.
The Leukemia and Lymphoma Society
Therapeutics, Inc.
Veristat, Inc.
PPD
Investigators
| Principal Investigator: | Joan Guitart, MD | Northwestern University |
More Information
No publications provided
| Responsible Party: | Shape Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01433731 History of Changes |
| Other Study ID Numbers: | SHP-141-001 |
| Study First Received: | September 9, 2011 |
| Last Updated: | February 6, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Shape Pharmaceuticals, Inc.:
|
CTCL Cutaneous T-Cell Lymphoma |
Additional relevant MeSH terms:
|
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 Histone Deacetylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013