Phase 2 study of HDACi JNJ-26481585 in subjects with CTCL

• Research type

  Research Study

• Full title

  A Phase 2, Single-Arm, Open-label, Multicenter Study of the Histone Deacetylase Inhibitor (HDACi) JNJ-26481585 on Subjects with Previously Treated Stage Ib-IVa Cutaneous T-cell Lymphoma

• IRAS ID

  83095

• Contact name

  Sean Whittaker

• Sponsor organisation

  Janssen Cilag International

• Eudract number

  2011-001076-18

• ISRCTN Number

  NA

• Research summary

  This study is being conducted on behalf of Johnson & Johnson Pharmaceutical Research & Development and is being performed on patients at least 18 years of age with Stage Ib to IVa cutaneous T-cell lymphoma (CTCL).JNJ-26481585 is an experimental drug that has not been approved by any regulatory authority for the treatment of patients with lymphoma, including CTCL. JNJ-26481585 is a type of oral drug known as an HDAC inhibitor (histone deacetylase inhibitor). The purpose of this study is to determine the efficacy and safety of JNJ-26481585 administered at doses of 8 mg or 12 mg on 3 days a week on alternate days to patients with CTCL. This is a study in which treatment will be assigned randomly (by chance) and all participants will know the identity of the treatment. 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.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  11/SC/0339

• Date of REC Opinion

  8 Sep 2011

• REC opinion

  Further Information Favourable Opinion