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CO-338-085: A Phase 2, Open-Label Study of Rucaparib in Patients with Locally Advanced or Metastatic Urothelial Carcinoma

This research is being done to find out more about the drug called rucaparib (also known as CO-338) and Rubraca. Rucaparib is being developed by Clovis Oncology, Inc. (“Sponsor”), a biopharmaceutical company with headquarters in the United States (US). Rucaparib is approved (trade name: Rubraca) in the US as treatment for patients with advanced ovarian cancer who have been treated with two or more chemotherapies and who have a certain type of abnormal BRCA gene.
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Be ≥ 18 years of age at the time the Informed Consent Form (ICF) is signed.
Received 1 or 2 prior standard of care treatment regimens
Mandatory tumor tissue must be collected
Have measurable disease
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 14 days prior to first dose of rucaparib.
Exclusion Criteria:
Prior treatment with a PARP inhibitor.
Pre-existing duodenal stent and/or any gastrointestinal disorder or defect that would, in the opinion of the investigator, interfere with absorption of rucaparib.
Non-study related minor surgical procedure ≤ 5 days, or major surgical procedure ≤ 21 days, prior to first dose of rucaparib; in all cases, the patient must be sufficiently recovered and stable before treatment administration.
Pregnant or breast feeding.
Refusal to use highly effective method of contraception or to practice true abstinence during treatment and for 6 months after the last dose of rucaparib
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Hershey, PA