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
All patients entered in the study will receive treatment with JNJ-26481585. This study will
have three phases: a Screening Phase (from signing of informed consent until immediately
before dosing), a Treatment Phase (from the first dose of study drug until the
End-of-Treatment Visit), and a Follow-up Phase (after the End-of-Treatment Visit until
clinical cut-off). Clinical cut-off is defined as when the last patient in the study has
been assessed with progressive disease or died, or 6 months after the last patient is
randomly assigned to treatment, whichever occurs first. However, if any patients are still
receiving study treatment at the time of clinical cut-off, these patients will enter a
Long-term Extension Phase and continue to receive study treatment until a reason for
discontinuation is met (ie, disease progression, toxicity, availability of other effective
drugs that the patient 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. Patients will be closely monitored for adverse events (AEs), laboratory
abnormalities, and clinical response, according to the scheduled assessments. The patients
will receive JNJ-26481585, 12 mg, orally on Days 1, 3, and 5 of each week in a 21-day
treatment cycle. JNJ-26481585 is to be taken with approximately 200 mL of water once a day.
Treatment will continue until disease progression or unacceptable toxicity occurs.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine overall cutaneous response (RR) rate, based on modified Severity Weighted Assessment Tool (mSWAT) criteria
The RR is defined as the proportion of evaluable subjects who achieve a CR (complete disappearance of all cutaneous disease) or PR (≥ 50% reduction in mSWAT score compared with baseline). mSWAT score : The skin tumor burden will be assessed according to mSWAT evaluation. The investigator will determine the percentage of total body surface area (TBSA) affected in 12 body regions, using the subject's palm and fingers representing 1% of TBSA.
Up to two years
No
Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC
United States: Food and Drug Administration
CR018640
NCT01486277
November 2011
November 2014
Name | Location |
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Philadelphia, Pennsylvania 19104 |