A Study of the Histone Deacetylase Inhibitor (HDACi) Quisinostat (JNJ-26481585) in Patients With Previously Treated Stage Ib-IVa Cutaneous T-cell Lymphoma

NCT01486277 | Completed Phase 2

• 3 other identifiers: CR0186402011-001076-1826481585LYM2001
• Study Type: interventional
• Target: 26
• Locations: 6 countries
• Sites: 13

Brief Summary

The purpose of this study is to determine the overall cutaneous response rate (participants who achieve a complete response or partial response) based on the modified severity weighted assessment tool criteria.

Conditions

Lymphoma, T-Cell, Cutaneous

Keywords

Lymphoma, T-Cell, Cutaneous; T-cell lymphoma; Lymphoma; Histone Deacetylase Inhibitor; JNJ-26481585

Outcome Measures

Primary Outcomes (1)

• Number of participants who will achieve overall cutaneous Response Rate (RR) based on modified Severity Weighted Assessment Tool (mSWAT) criteria

  The RR is defined as the number of participants who will achieve a complete response (CR) or partial response (PR). mSWAT criteria is used to evaluate the skin tumor burden. The investigator will determine the percentage of total body surface area (TBSA) affected by patches, plaques or tumors in 12 body regions, using the participant's palm and fingers representing 1% of TBSA. CR is defined as 100% clearance of skin lesions and PR is defined as 50% to 99 % clearance of skin lesions from baseline without occurrence of a new tumor.

  From screening until progressive disease or confirmed lost to follow-up or death or start of alternate therapy, or withdrawal from the study; as assessed for approximately 6 months after the enrollment of the last participant

Secondary Outcomes (7)

• Number of participants who will achieve global Response Rate (RR) based on based on consensus global response score

  From screening until progressive disease or confirmed lost to follow-up or death from any cause or start of alternate therapy, or withdrawal from the study; as assessed for approximately 6 months after the enrollment of the last participant

• Progression-Free Survival (PFS)

  From the date of administration of the first dose of study medication until progressive disease or death from any cause, whichever occurs first; as assessed for approximately 6 months after the enrollment of the last participant

• Kaplan-Meier Estimates of 1-year overall survival (OS) rate

  From the date of administration of the first dose of study medication up to the date of progressive disease or death, whichever occurs first; as assessed up to 1 year

• Duration of response (DOR) for participants achieving Complete Response (CR) or Partial Response (PR)

  First documentation of CR or PR until the date of first documentation of progressive disease, or death from any cause; as assessed for approximately 6 months after the enrollment of the last participant

• The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

  From screening until progressive disease or confirmed lost to follow-up or death from any cause or start of alternate therapy, or withdrawal from the study; as assessed for approximately 6 months after the enrollment of the last participant

Study Arms (1)

Quisinostat

EXPERIMENTAL

Participants will receive quisinostat 12 mg capsule orally (by mouth) on Days 1, 3, and 5 of each week in a 21-day treatment cycle, until a reason for discontinuation is met (ie, disease progression, toxicity, availability of other effective medications that the participant may receive, or treating physician advice).

Drug: Quisinostat, 12 mg

Interventions

Quisinostat, 12 mg DRUG

Participants will receive quisinostat 12 mg capsule orally (by mouth) on Days 1, 3, and 5 of each week in a 21-day treatment cycle, until a reason for discontinuation is met (ie, disease progression, toxicity, availability of other effective medications that the participant may receive, or treating physician advice).

Also known as: JNJ 26481585

Quisinostat

Eligibility Criteria

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

You may qualify if:

• Histopathologically confirmed cutaneous T-cell lymphoma (CTCL), either mycosis fungoides or sezary syndrome Stage Ib-IVa
• Relapsed or refractory (unresponsive) disease following at least 1 prior systemic therapy for CTCL, except psoralen and long-wave ultraviolet radiation (it is considered skin-directed therapy and not systemic therapy)
• Stable anti-pruritus regimen (topical corticosteroids or antihistamine) in the preceding 28 days
• Measurable disease with at least 1 skin lesion (patch, plaque, or tumor) 1 cm or greater than 1 cm in the longest diameter laboratory function tests and bone marrow test
• Agrees to protocol defined use of effective contraception
• Adequate laboratory function tests and bone marrow test

You may not qualify if:

• Prior histone-deacetylase inhibitor therapy for CTCL
• Concurrent systemic corticosteroid dose greater than 10 mg per day of prednisone or equivalent (stable use of 10 mg or less than 10 mg per day of prednisone for 1 month or more before study entry is allowed)
• Major surgery or radiotherapy within 3 weeks before the start of the study medication
• Unstable angina or heart attack within the preceding 12 months, congestive heart failure New York Heart Association Class II-IV, known presence of dilated, hypertrophic, or restrictive cardiomyopathy
• Inadequate gastrointestinal absorption status
• Use of potent inhibitors of CYP3A4/A5
• Positive human immunodeficiency virus

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (13)

Unknown Facility

Pittsburgh, Pennsylvania, United States

Location

Unknown Facility

Nantes, France

Location

Unknown Facility

Paris, France

Location

Unknown Facility

Pessac, France

Location

Unknown Facility

Kiel, Germany

Location

Unknown Facility

Minden, Germany

Location

Unknown Facility

Lisbon, Portugal

Location

Unknown Facility

Porto, Portugal

Location

Unknown Facility

Madrid, Spain

Location

Unknown Facility

Málaga, Spain

Location

Unknown Facility

Valencia, Spain

Location

Unknown Facility

London, United Kingdom

Location

Unknown Facility

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous; Lymphoma, T-Cell; Lymphoma

Interventions

quisinostat

Condition Hierarchy (Ancestors)

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

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2011
• First Posted: December 6, 2011
• Study Start: November 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: July 1, 2016
• Last Updated: November 3, 2016

Record last verified: 2016-11

Locations

ES (3); GB (2); DE (2); PT (2); FR (3); US (1)