Edition:
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Clovis Oncology Says Discontinuing Phase 2 Monotherapy Clinical Trial Evaluating Rucaparib In Bladder Cancer


Saturday, 13 Apr 2019 

April 12 (Reuters) - Clovis Oncology Inc ::CLOVIS ONCOLOGY - DISCONTINUING SPONSORED PHASE 2 OPEN-LABEL MONOTHERAPY CLINICAL TRIAL EVALUATING RUCAPARIB IN RECURRENT, METASTATIC BLADDER CANCER.CLOVIS - DISCONTINUATION DECISION BASED ON RECOMMENDATIONS BY INDEPENDENT DMC AFTER REVIEW OF PRELIMINARY EFFICACY DATA FOR 62 PATIENTS IN STUDY.CLOVIS- PRELIM DATA IN STUDY DEMONSTRATED OBJECTIVE RESPONSE RATE IN INTENT-TO-TREAT POPULATION DOES NOT MEET PROTOCOL-DEFINED CONTINUANCE CRITERIA.CLOVIS - PRELIMINARY DATA IN STUDY SUGGESTS TREATMENT WITH MONOTHERAPY RUCAPARIB MAY NOT PROVIDE MEANINGFUL CLINICAL BENEFIT TO PATIENTS.CLOVIS ONCOLOGY INC - DMC RECOMMENDED TO STOP ENROLLMENT TO STUDY, AND CLOVIS HAS DECIDED TO TERMINATE ATLAS TRIAL EARLY.CLOVIS ONCOLOGY INC - RECOMMENDATION OF DMC WAS NOT BASED ON SAFETY PROFILE OF RUCAPARIB IN THIS STUDY POPULATION.CLOVIS ONCOLOGY INC - CONTINUING TO EVALUATE POTENTIAL FOR RUCAPARIB IN COMBINATION WITH OTHER AGENTS FOR TREATMENT OF ADVANCED BLADDER CANCER.CLOVIS - TO ENROLL PATIENTS WITH ADVANCED BLADDER CANCER & SELECTED GENETIC MUTATIONS IN PLANNED PAN-TUMOR TRIAL OF RUCAPARIB EXPECTED TO START H2 2019.