Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the global ARIEL2 (Assessment of Rucaparib in Ovarian Cancer Phase 2 Trial) study of rucaparib has commenced with the dosing of the first patient at a U.S. study site. Rucaparib is the Company’s oral, potent, small molecule poly (ADP-ribose) polymerase (PARP) inhibitor being developed for the treatment of platinum sensitive, relapsed ovarian cancer.
“I am delighted to be starting this important and timely trial,” said Professor Iain Mcneish, Professor of Gynecological Oncology, Institute of Cancer Sciences, University of Glasgow and one of the two chief investigators of the ARIEL2 study. “We have found there are many ovarian cancer patients who do not carry germline BRCA mutations yet still benefit from PARP inhibitor therapy. This study is designed specifically to help identify these women using tumor DNA sequencing, which is a viable approach since nearly all ovarian cancer patients have plentiful tumor tissue samples following de-bulking surgery. Platinum sensitivity alone may not be the best predictor of PARP inhibitor outcome and I am confident we can do much better for patients using tumor genetic analysis.”
“We are pleased to move forward with the international ARIEL clinical program, beginning with ARIEL2 today, and followed closely by our ARIEL3 pivotal study which will initiate by the end of this year,” said Patrick J. Mahaffy, president and CEO of Clovis Oncology. “PARP inhibitors have the potential to provide meaningful clinical benefit to many women with ovarian cancer, and ARIEL2 is designed to identify the broader population of patients who likely benefit from rucaparib therapy, beyond the germline BRCA mutation carrier population.”
ARIEL2 is a single-arm, open-label, Phase 2 study designed to identify tumor characteristics that predict sensitivity to rucaparib using DNA sequencing to evaluate each patient’s tumor. Tumor samples from study participants will be tested for BRCA1 and BRCA2 mutations (genes that are linked to hereditary breast and ovarian cancers), as well as other biomarkers that are expected to confer sensitivity to PARP inhibitor therapy. All patients in the study will receive both rucaparib and their molecular test results (including tumor BRCA status), and be treated until their disease progresses or until they withdraw from the study.
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