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

NCT ID: NCT01486277

Last Updated: 2016-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2016-07-31

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.

Detailed Description

This is a single-arm (group), open-label (all people know the identity of the intervention), and multicenter study. The study consists of 3 phases including, the screening phase (within 28 days prior to the start of study medication), treatment phase (participants will receive quisinostat) and follow-up phase (30 days after the last dose of study medication until death or clinical cutoff). Clinical cut-off is defined as when the last participant will be assessed with progressive disease or died, or 6 months after the last participant enrolled, whichever occurs first. However, if any participants are still receiving study treatment at the time of clinical cut-off, these participants will enter a long-term extension phase and will continue to receive study medication 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). The long-term extension phase will continue for a maximum of 2 years beyond the clinical cut-off for primary analysis. Safety will be evaluated by the assessment of adverse events, vital signs, physical examination, 12-lead electrocardiogram, and clinical laboratory tests which will be monitored in this study. Any participants responding to treatment at the end of the 2-year long-term extension phase will be able to continue to receive quisinostat as long as they are assessed by the investigator as not meeting treatment discontinuation criteria; during this time, only information related to serious adverse events will be collected.

Conditions

Lymphoma, T-Cell, Cutaneous

Keywords

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Quisinostat

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).

Group Type: EXPERIMENTAL

Quisinostat, 12 mg

Intervention Type: 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).

Interventions

Quisinostat, 12 mg

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).

Intervention Type: DRUG

Other Intervention Names

JNJ 26481585

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Pittsburgh, Pennsylvania, United States

Nantes, , France

Paris, , France

Pessac, , France

Kiel, , Germany

Minden, , Germany

Lisbon, , Portugal

Porto, , Portugal

Madrid, , Spain

Málaga, , Spain

Valencia, , Spain

London, , United Kingdom

Manchester, , United Kingdom

Countries

United States; France; Germany; Portugal; Spain; United Kingdom

Other Identifiers

2011-001076-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

26481585LYM2001

Identifier Type: OTHER

Identifier Source: secondary_id

CR018640

Identifier Type: -

Identifier Source: org_study_id

NCT01389960

Identifier Type: -

Identifier Source: nct_alias