A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AstraZeneca
Study ID
NCT03459846
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Urinary Bladder Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Durvalumab 1500 mg IV q4w
  • Olaparib — DRUG
    Olaparib PO 300 mg BID adjusted based on patient's creatinine clearance.
  • Placebo — DRUG
    Matching placebo for oral tablet BID

Study Details

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

Key Dates

Start date
Mar 16, 2018
Status verified
May 2026
Primary completion
Oct 15, 2020
Completion
Dec 31, 2026

Study Design

Enrollment
154 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Durvalumab/Placebo
    Durvalumab 1500 mg intravenous (IV) every 4 weeks (q4w) starting on week 1 day 1/Placebo orally (PO) twice a day (BID) starting on week 1 day 1.
  • Experimental: Arm 2: Durvalumab/Olaparib
    Durvalumab 1500 mg IV q4w starting on week 1 day 1/Olaparib PO 300 mg BID adjusted based on patient's creatinine clearance.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Assessments performed at baseline and every 8 weeks from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), assessed up to the data cut-off date (15 Oct 2020), up to a max. of 31 months ]

Locations (12)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama35294-
Research SiteGoodyearArizona85338-
Research SiteFort MyersFlorida33901-
Research SiteSt. PetersburgFlorida33705-
Research SiteTampaFlorida33612-
Research SiteLouisvilleKentucky40202-
Research SiteNew Hyde ParkNew York11042-
Research SiteNew YorkNew York10065-
Research SiteThe BronxNew York10461-
Research SitePhiladelphiaPennsylvania19124-
Research SiteNashvilleTennessee37232-
Research SiteTacomaWashington98405-

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By research site
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