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Pharmacyclics Reports Third Quarter 2013 Results
Date:11/7/2013

single-arm, multi-center trial of ibrutinib as a monotherapy in R/R MCL patients who received at least one prior rituximab-containing chemotherapy regimen and who progressed after bortezomib therapy. The primary endpoint of the study is ORR. Enrollment in MCL2001 was completed in April of 2013 with 120 patients enrolled.
  • RAY (MCL3001): Phase III study of ibrutinib versus temsirolimus in R/R MCL patients started in the fourth quarter of 2012. This is a randomized, multi-center, open-label trial of ibrutinib as a monotherapy versus temsirolimus in R/R MCL patients who received at least one prior rituximab-containing chemotherapy regimen. The primary endpoint of the study is PFS. The enrollment target of this global study is 280 patients.
  • SHINE (MCL3002): Phase III study of ibrutinib in combination with bendamustine and rituximab in elderly patients with newly diagnosed MCL started in the second quarter of 2013. This is a randomized, multi-center, double-blinded, placebo-controlled trial of ibrutinib plus bendamustine and rituximab versus placebo plus bendamustine and rituximab in patients 65 years or older with newly diagnosed MCL. The primary endpoint of the study is PFS. The enrollment target of this global study is 520 patients.
  • MCL4001: A multicenter, open label Expanded Access Program for ibrutinib as a monotherapy in relapsed/refractory (R/R) MCL patients was initiated in the US in the second quarter of 2013. EAPs are clinical studies allowed under certain circumstances by the FDA. They are designed to provide a mechanism for access to an investigational drug to treat patients with a serious or immediately life-threatening diseases or conditions until the time of an anticipated U.S. marketing approval. Further information about this program can be found on www.clinicaltrials.gov.
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  • PCYC-1106: Phase II study of ibrutinib in patients with relapsed or refractory d
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  • SOURCE Pharmacyclics, Inc.
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