Safety, Pharmacodynamics (PD), Pharmacokinetics (PK) Study of SHP141 in 1A, 1B, or 2A Cutaneous T-Cell Lymphoma (CTCL)

This study has been completed.
Sponsor:
Collaborators:
The Leukemia and Lymphoma Society
Therapeutics, Inc.
Veristat, Inc.
PPD
Information provided by (Responsible Party):
TetraLogic Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01433731
First received: September 9, 2011
Last updated: February 23, 2016
Last verified: January 2016
  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: placebo for SHAPE (SHP-141)
Drug: SHAPE (SHP-141) 0.1% BID
Drug: SHAPE (SHP-141) 0.5% BID
Drug: SHAPE (SHP-141) 1.0% BID
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 TetraLogic Pharmaceuticals:

Primary Outcome Measures:
  • Percentage of Patients With Complete or Partial Response as Measured by Change in 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 ]
    Response assessed by change in lesion severity using Composite Assessment of Index Lesion Severity (CAILS) Assessment Tool which measures clinical signs of CTCL by erythema; scaling; plaque elevation; hypo- or hyperpigmentation, each on a scale of 0-8; and lesion size (cm2), on a scale of 0 (no lesion; 0 cm2) to 18 (300 cm2). Up to five index lesions are each scored, and a subtotal CAILS score is provided for each index lesion. A total score is calculated by summing these subtotals. Response criteria measure the change in CAILS score from baseline to follow-up as follows: Complete Response (CR): 100% decrease in CAILS score; Partial Response (PR): 50% - 99% decrease in CAILS score; Stable Disease (SD): < 25% increase to < 50% decrease in CAILS score; Progressive Disease (PD) ≥ 25% increase in CAILS score.


Enrollment: 18
Study Start Date: November 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo for SHAPE (SHP-141)
placebo for SHAPE (SHHP-141) topical gelled solution
Drug: placebo for SHAPE (SHP-141)
topical gelled solution
Experimental: SHAPE (SHP-141) 0.1%BID
SHAPE (SHP-141) topical gelled solution at 0.1% concentration twice weekly
Drug: SHAPE (SHP-141) 0.1% BID
topical gelled solution
Experimental: SHAPE (SHP-141) 0.5% BID
SHAPE (SHP-141) topical gelled solution at 0.5% concentration twice weekly
Drug: SHAPE (SHP-141) 0.5% BID
topical gelled solution
Experimental: SHAPE (SHP-141) 1.0% BID
SHAPE (SHP-141) topical gelled solution at 1.0% concentration twice weekly
Drug: SHAPE (SHP-141) 1.0% BID
topical gelled solution

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01433731

Locations
United States, California
Stanford University
Stanford, California, United States, 94305
United States, Illinois
Northwestern University Dept of Dermatology
Chicago, Illinois, United States, 60611
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Ohio State University
Gahanna, Ohio, United States, 43230
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
TetraLogic Pharmaceuticals
The Leukemia and Lymphoma Society
Therapeutics, Inc.
Veristat, Inc.
PPD
Investigators
Principal Investigator: Joan Guitart, MD Northwestern University
  More Information

Responsible Party: TetraLogic Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01433731     History of Changes
Other Study ID Numbers: SHP-141-001 
Study First Received: September 9, 2011
Results First Received: December 15, 2015
Last Updated: February 23, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by TetraLogic Pharmaceuticals:
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

ClinicalTrials.gov processed this record on July 27, 2016