Back to results

Efficacy, Safety and Tolerability Study of SHAPE in IA, IB or IIA Cutaneous T-cell Lymphoma

Primary Purpose

Cutaneous T-Cell Lymphoma (CTCL)

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

SHAPE

About this trial

This is an interventional treatment trial for Cutaneous T-Cell Lymphoma (CTCL) focused on measuring CTCL, Cutaneous T-Cell Lymphoma, Early-stage, SHAPE, SHP-141, topical, Histone deacetylase inhibitor, CAILS, mSWAT, mycosis fungoides

Eligibility Criteria

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

Inclusion Criteria:

Histological confirmation of CTCL; a documented verifiable biopsy report is required
Documented clinical stage IA, IB or IIA CTCL
Skin lesion involvement of at least 2% of BSA accessible for topical application of study drug
ECOG performance status of 0-2

Exclusion Criteria:

CTCL with histologic evidence of folliculotropic variant or large cell transformed CTCL
Palpable lymph node ≥1.5 cm in diameter (unless the lymph node has been biopsied and designated as Stage IA-IIA disease)
Co-existent second malignancy or history of prior solid organ malignancy within previous 5 years (excluding basal or squamous cell carcinoma, in situ carcinoma of the cervix (CIN3), papillary or follicular thyroid cancer or prostate cancer that has been treated curatively
Any prior history of hematologic malignancy (other than CTCL) within past 5 years
CTCL disease that is known to be refractory to systemic histone deacetylase inhibitors
Prior or concurrent central nervous system (CNS) metastases
History of or current major gastrointestinal, pulmonary, cardiovascular, genitourinary or hematologic 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 of clinical significance

Sites / Locations

Stanford Cancer Center
Northwestern Medical Group
Dana-Farber Cancer Institute
The Ohio State University Wexner Medical Center
The University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

1.0% SHAPE Gelled Solution once daily

0.5% SHAPE Gelled Solution twice daily

1.0% SHAPE Gelled Solution twice daily

Arm Description

Outcomes

Primary Outcome Measures

Lesion severity using CAILS (Composite Assessment of Index Lesion Severity)

Secondary Outcome Measures

modified Severity Weighted Assessment Tool (mSWAT)

Patient assessment of pruritis using a Visual Analog Scale (VAS)

Skindex-29 Quality of Life Tool

modified Composite Assessment of Index Lesion Severity (CAILS)

Full Information

NCT ID

NCT02213861

First Posted

August 6, 2014

Last Updated

October 18, 2016

Sponsor

TetraLogic Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02213861

Brief Title

Efficacy, Safety and Tolerability Study of SHAPE in IA, IB or IIA Cutaneous T-cell Lymphoma

Official Title

A Randomized Phase 2 Study to Evaluate Three Treatment Regimens of SHAPE, a Histone Deacetylase Inhibitor, in Patients With Stage IA, IB or IIA Cutaneous T-Cell Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Unknown status

Study Start Date

November 2014 (undefined)

Primary Completion Date

October 2016 (Anticipated)

Study Completion Date

October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

TetraLogic Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of SHAPE administered topically to skin lesions in patients with early-stage cutaneous T-cell lymphoma (CTCL).

Detailed Description

This is a Phase 2, multicenter, open-label, randomized study to evaluate the efficacy and safety of SHAPE Gelled Solution applied topically daily or twice daily for 26 consecutive weeks to specified skin lesions in patients with Stage IA, IB or IIA CTCL. Patients responding to treatment will be allowed to continue on study for a maximum of 52 weeks.

6. Conditions and Keywords

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

Cutaneous T-Cell Lymphoma (CTCL)

Keywords

CTCL, Cutaneous T-Cell Lymphoma, Early-stage, SHAPE, SHP-141, topical, Histone deacetylase inhibitor, CAILS, mSWAT, mycosis fungoides

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

1.0% SHAPE Gelled Solution once daily

Arm Type

Experimental

Arm Title

0.5% SHAPE Gelled Solution twice daily

Arm Type

Experimental

Arm Title

1.0% SHAPE Gelled Solution twice daily

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

SHAPE

Other Intervention Name(s)

SHP-141

Intervention Description

topical gel

Primary Outcome Measure Information:

Title

Lesion severity using CAILS (Composite Assessment of Index Lesion Severity)

Time Frame

Every 4 weeks for 26 weeks and every 4 weeks thereafter for patients who continue on study (up to 52 weeks).

Secondary Outcome Measure Information:

Title

modified Severity Weighted Assessment Tool (mSWAT)

Time Frame

Every 4 weeks for 26 weeks and every 4 weeks therafter for patients who continue on study (up to 52 weeks).

Title

Patient assessment of pruritis using a Visual Analog Scale (VAS)

Time Frame

Every 4 weeks for 26 weeks and every 4 weeks thereafter for patients who continue on study (up to 52 weeks).

Title

Skindex-29 Quality of Life Tool

Time Frame

Every 4 weeks for 26 weeks

Title

modified Composite Assessment of Index Lesion Severity (CAILS)

Time Frame

Every 4 weeks for 26 weeks and every 4 weeks therafter for patients who continue on study (up to 52 weeks).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histological confirmation of CTCL; a documented verifiable biopsy report is required Documented clinical stage IA, IB or IIA CTCL Skin lesion involvement of at least 2% of BSA accessible for topical application of study drug ECOG performance status of 0-2 Exclusion Criteria: CTCL with histologic evidence of folliculotropic variant or large cell transformed CTCL Palpable lymph node ≥1.5 cm in diameter (unless the lymph node has been biopsied and designated as Stage IA-IIA disease) Co-existent second malignancy or history of prior solid organ malignancy within previous 5 years (excluding basal or squamous cell carcinoma, in situ carcinoma of the cervix (CIN3), papillary or follicular thyroid cancer or prostate cancer that has been treated curatively Any prior history of hematologic malignancy (other than CTCL) within past 5 years CTCL disease that is known to be refractory to systemic histone deacetylase inhibitors Prior or concurrent central nervous system (CNS) metastases History of or current major gastrointestinal, pulmonary, cardiovascular, genitourinary or hematologic 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 of clinical significance

Facility Information:

Facility Name

Stanford Cancer Center

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

Northwestern Medical Group

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Dana-Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

The Ohio State University Wexner Medical Center

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

The University of Texas MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

32632956

Citation

Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.

Results Reference

derived

Learn more about this trial

Efficacy, Safety and Tolerability Study of SHAPE in IA, IB or IIA Cutaneous T-cell Lymphoma

We'll reach out to this number within 24 hrs