A Study of the Histone Deacetylase Inhibitor (HDACi) JNJ-26481585 in Patients With Previously Treated Stage Ib-IVa Cutaneous T-cell Lymphoma
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2011 |
| End Date: | July 2016 |
A Phase 2, Single-arm, Open-label, Multicenter Study of the Histone Deacetylase Inhibitor (HDACi) JNJ-26481585 in Subjects With Previously Treated Stage Ib-IVa Cutaneous T-cell Lymphoma
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.
who achieve a complete response or partial response) based on the modified severity weighted
assessment tool criteria.
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
JNJ-26481585) 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.
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
JNJ-26481585) 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.
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
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