Btk inhibitor PCI-32765, phase 2 study in relapsed or refractory MCL

• Research type

  Research Study

• Full title

  Multicenter phase 2 study of Bruton’s tyrosine kinase (Btk) inhibitor, PCI-32765, in relapsed or refractory mantle cell lymphoma

• IRAS ID

  72003

• Contact name

  Simon Rule

• Sponsor organisation

  Pharmacyclics, Incorporated

• Eudract number

  2010-022939-11

• Clinicaltrials.gov Identifier

  NCT01236391

• Research summary

  This is a proof-of-concept, Phase 2, multi-centre study designed to assess the safety and efficacy of PCI-32765 in subjects with relapsed/refractory MCL (Mantle Cell Lymphoma). Approximately 100 participants will be enrolled in this trial, stratified into 2 equal sample sized groups of subjects based on prior bortezomib exposure (one of only two drugs licenced for this disease, but not licensed in Europe for MCL). Participants must have received between 1 and 5 prior treatments for MCL. PCI-32765 is a ??kinase inhibitor?. ??Kinases? are proteins inside cells that help cells live and grow. By inhibiting the activity of this specific kinase (protein), the study drug is expected to kill the cancer cells or stop them from growing.All participants meeting eligibility criteria will receive PCI 32765 capsules at a dosage of 560 mg/day once daily for a 28 day cycle. Participants may continue on the study drug indefinitely as long as: a) the subject is deriving clinical benefit and b) the subject is not experiencing any unacceptable toxicity. Participants with disease progression will be removed from the study.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  11/SW/0031

• Date of REC Opinion

  17 May 2011

• REC opinion

  Further Information Favourable Opinion