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.

Study Overview

• Status: Completed
• Conditions: Lymphoma, T-Cell, Cutaneous
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Dept of Dermatology
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Case Medical Center
    • Gahanna, Ohio, United States, 43230
      • Ohio State University
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients With Complete or Partial Response as Measured by Change in Lesion Severity Using CAILS (Composite Assessment of Index Lesion Severity)	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.	Weekly through day 28 (days 1, 7, 14, 21, 28) and again day 42

Collaborators and Investigators

• Sponsor: TetraLogic Pharmaceuticals
• Collaborators: PPD; The Leukemia and Lymphoma Society; Veristat, Inc.; Therapeutics, Inc.
• Investigators: Principal Investigator: Joan Guitart, MD, Northwestern University

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: September 9, 2011
• First Submitted That Met QC Criteria: September 12, 2011
• First Posted (Estimate): September 14, 2011

Study Record Updates

• Last Update Posted (Estimate): March 24, 2016
• Last Update Submitted That Met QC Criteria: February 23, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: CTCL; Cutaneous T-Cell Lymphoma
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell, Cutaneous
• Other Study ID Numbers: SHP-141-001