NCT02213861

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 12, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 20, 2016

Status Verified

October 1, 2016

Enrollment Period

1.9 years

First QC Date

August 6, 2014

Last Update Submit

October 18, 2016

Conditions

Cutaneous T-Cell Lymphoma (CTCL)

Keywords

CTCLCutaneous T-Cell LymphomaEarly-stageSHAPESHP-141topicalHistone deacetylase inhibitorCAILSmSWATmycosis fungoides

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (4)

  • modified Severity Weighted Assessment Tool (mSWAT)

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

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

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

  • Skindex-29 Quality of Life Tool

    Every 4 weeks for 26 weeks

  • modified Composite Assessment of Index Lesion Severity (CAILS)

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

Study Arms (3)

1.0% SHAPE Gelled Solution once daily

EXPERIMENTAL
Drug: SHAPE

0.5% SHAPE Gelled Solution twice daily

EXPERIMENTAL
Drug: SHAPE

1.0% SHAPE Gelled Solution twice daily

EXPERIMENTAL
Drug: SHAPE

Interventions

SHAPEDRUG

topical gel

Also known as: SHP-141
0.5% SHAPE Gelled Solution twice daily1.0% SHAPE Gelled Solution once daily1.0% SHAPE Gelled Solution twice daily

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Stanford Cancer Center

Stanford, California, 94305, United States

Location

Northwestern Medical Group

Chicago, Illinois, 60611, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 32632956DERIVED

MeSH Terms

Conditions

Lymphoma, T-Cell, CutaneousMycosis Fungoides

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2014

First Posted

August 12, 2014

Study Start

November 1, 2014

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

October 20, 2016

Record last verified: 2016-10

Locations

US(5)