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

NCT01433731 | Completed Phase 1 Results DMC

• 1 other identifier: SHP-141-001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Lymphoma, T-Cell, Cutaneous

Keywords

CTCL; Cutaneous T-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

placebo for SHAPE (SHP-141)

PLACEBO COMPARATOR

placebo for SHAPE (SHHP-141) topical gelled solution

Drug: placebo for SHAPE (SHP-141)

SHAPE (SHP-141) 0.1%BID

EXPERIMENTAL

SHAPE (SHP-141) topical gelled solution at 0.1% concentration twice weekly

Drug: SHAPE (SHP-141) 0.1% BID

SHAPE (SHP-141) 0.5% BID

EXPERIMENTAL

SHAPE (SHP-141) topical gelled solution at 0.5% concentration twice weekly

Drug: SHAPE (SHP-141) 0.5% BID

SHAPE (SHP-141) 1.0% BID

EXPERIMENTAL

SHAPE (SHP-141) topical gelled solution at 1.0% concentration twice weekly

Drug: SHAPE (SHP-141) 1.0% BID

Interventions

placebo for SHAPE (SHP-141) DRUG

topical gelled solution

placebo for SHAPE (SHP-141)

SHAPE (SHP-141) 0.1% BID DRUG

topical gelled solution

SHAPE (SHP-141) 0.1%BID

SHAPE (SHP-141) 0.5% BID DRUG

topical gelled solution

SHAPE (SHP-141) 0.5% BID

SHAPE (SHP-141) 1.0% BID DRUG

topical gelled solution

SHAPE (SHP-141) 1.0% BID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%

Sponsors & Collaborators

• TetraLogic Pharmaceuticals: lead
• The Leukemia and Lymphoma Society: collaborator
• Therapeutics, Inc.: collaborator
• Veristat, Inc.: collaborator
• PPD Development, LP: collaborator

Study Sites (6)

Stanford University

Stanford, California, 94305, United States

Location

Northwestern University Dept of Dermatology

Chicago, Illinois, 60611, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Ohio State University

Gahanna, Ohio, 43230, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous

Interventions

BID protein, human

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Vice President, Clinical Research
• Organization: TetraLogic Pharmaceuticals

jeffrey.skolnik@tetralogicpharma.com

610-889-9900

Study Officials

• Joan Guitart, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2011
• First Posted: September 14, 2011
• Study Start: November 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: March 24, 2016
• Results First Posted: March 24, 2016

Record last verified: 2016-01

Locations

US (6)