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Active Not Recruiting
NCT03459846
A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU)
Conditions: Urinary Bladder Neoplasms
Sex: All
Ages: 18 Years – 130 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 154
Sponsor: AstraZeneca
Location: Research Site Birmingham Alabama
Summary
A Phase II, Randomized, Multi-Center, Double-Blind, Comparative Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With Olaparib for First-Line Treatment in Platinum-Ineligible Patients With Unresectable Stage IV Urothelial Cancer
Eligibility Criteria
Inclusion criteria:
1. Provision of signed and dated, written ICF
2. Histologically or cytologically documented TCC/UC of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra) also meeting the following: Unresectable, Stage IV disease; No prior systemic therapy for unresectable, Stage IV disease.
3. Ineligible for platinum-based chemotherapy defined as (i) in the opinion of the Investigator, unfit for carboplatin-based chemotherapy and (ii) meeting one of the following criteria: CrCl \
Source: ClinicalTrials.gov (NCT03459846). StuddyBuddy aggregates publicly available trial information.
