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

Primary Purpose

Lymphoma, T-Cell, Cutaneous

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

placebo for SHAPE (SHP-141)

SHAPE (SHP-141) 0.1% BID

SHAPE (SHP-141) 0.5% BID

SHAPE (SHP-141) 1.0% BID

About this trial

This is an interventional treatment trial for Lymphoma, T-Cell, Cutaneous focused on measuring CTCL, Cutaneous T-Cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%

Sites / Locations

Stanford University
Northwestern University Dept of Dermatology
University Hospitals Case Medical Center
Cleveland Clinic
Ohio State University
MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

placebo for SHAPE (SHP-141)

SHAPE (SHP-141) 0.1%BID

SHAPE (SHP-141) 0.5% BID

SHAPE (SHP-141) 1.0% BID

Arm Description

placebo for SHAPE (SHHP-141) topical gelled solution

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

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

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

Outcomes

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)

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01433731

First Posted

September 9, 2011

Last Updated

February 23, 2016

Sponsor

TetraLogic Pharmaceuticals

Collaborators

The Leukemia and Lymphoma Society, Therapeutics, Inc., Veristat, Inc., PPD

1. Study Identification

Unique Protocol Identification Number

NCT01433731

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

November 2011 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

TetraLogic Pharmaceuticals

Collaborators

The Leukemia and Lymphoma Society, Therapeutics, Inc., Veristat, Inc., PPD

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma, T-Cell, Cutaneous

Keywords

CTCL, Cutaneous T-Cell Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

placebo for SHAPE (SHP-141)

Arm Type

Placebo Comparator

Arm Description

placebo for SHAPE (SHHP-141) topical gelled solution

Arm Title

SHAPE (SHP-141) 0.1%BID

Arm Type

Experimental

Arm Description

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

Arm Title

SHAPE (SHP-141) 0.5% BID

Arm Type

Experimental

Arm Description

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

Arm Title

SHAPE (SHP-141) 1.0% BID

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

placebo for SHAPE (SHP-141)

Intervention Description

topical gelled solution

Intervention Type

Drug

Intervention Name(s)

SHAPE (SHP-141) 0.1% BID

Intervention Description

topical gelled solution

Intervention Type

Drug

Intervention Name(s)

SHAPE (SHP-141) 0.5% BID

Intervention Description

topical gelled solution

Intervention Type

Drug

Intervention Name(s)

SHAPE (SHP-141) 1.0% BID

Intervention Description

topical gelled solution

Primary Outcome Measure Information:

Title

Percentage of Patients With Complete or Partial Response as Measured by Change in Lesion Severity Using CAILS (Composite Assessment of Index Lesion Severity)

Description

Time Frame

Weekly through day 28 (days 1, 7, 14, 21, 28) and again day 42

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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%

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joan Guitart, MD

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

Northwestern University Dept of Dermatology

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

University Hospitals Case Medical Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

Cleveland Clinic

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Ohio State University

City

Gahanna

State/Province

Ohio

ZIP/Postal Code

43230

Country

United States

Facility Name

MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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