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

September 9, 2011
February 23, 2016
November 2011
September 2013   (final data collection date for primary outcome measure)
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.
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 ]
Complete list of historical versions of study NCT01433731 on ClinicalTrials.gov Archive Site
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Safety, Pharmacodynamics (PD), Pharmacokinetics (PK) Study of SHP141 in 1A, 1B, or 2A Cutaneous T-Cell Lymphoma (CTCL)
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Lymphoma, T-Cell, Cutaneous
  • Drug: placebo for SHAPE (SHP-141)
    topical gelled solution
  • Drug: SHAPE (SHP-141) 0.1% BID
    topical gelled solution
  • Drug: SHAPE (SHP-141) 0.5% BID
    topical gelled solution
  • Drug: SHAPE (SHP-141) 1.0% BID
    topical gelled solution
  • Placebo Comparator: placebo for SHAPE (SHP-141)
    placebo for SHAPE (SHHP-141) topical gelled solution
    Intervention: Drug: placebo for SHAPE (SHP-141)
  • Experimental: SHAPE (SHP-141) 0.1%BID
    SHAPE (SHP-141) topical gelled solution at 0.1% concentration twice weekly
    Intervention: Drug: SHAPE (SHP-141) 0.1% BID
  • Experimental: SHAPE (SHP-141) 0.5% BID
    SHAPE (SHP-141) topical gelled solution at 0.5% concentration twice weekly
    Intervention: Drug: SHAPE (SHP-141) 0.5% BID
  • Experimental: SHAPE (SHP-141) 1.0% BID
    SHAPE (SHP-141) topical gelled solution at 1.0% concentration twice weekly
    Intervention: Drug: SHAPE (SHP-141) 1.0% BID
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
September 2013
September 2013   (final data collection date for primary outcome measure)

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%
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01433731
SHP-141-001
Yes
Not Provided
Not Provided
TetraLogic Pharmaceuticals
TetraLogic Pharmaceuticals
  • The Leukemia and Lymphoma Society
  • Therapeutics, Inc.
  • Veristat, Inc.
  • PPD
Principal Investigator: Joan Guitart, MD Northwestern University
TetraLogic Pharmaceuticals
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP