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NCT03459846 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Urinary Bladder Neoplasms, sponsored by AstraZeneca.

Active
Registry status
Phase 2
Development phase
154
Enrollment target
20
Study locations

NCT03459846 is a Phase 2 study of Urinary Bladder Neoplasms that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 154 participants, below the 305-participant average among 19 other Urinary Bladder Neoplasms trials with a reported enrollment target (50% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT03459846, a Phase 2 study of Urinary Bladder Neoplasms, is active but no longer recruiting, sponsored by AstraZeneca.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
154 participants
Enrollment target
20
Study locations

Study 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

Conditions Studied

Urinary Bladder Neoplasms

Interventions

  • DRUG Placebo
  • DRUG Olaparib
  • DRUG Durvalumab

Study Locations (20)

Ontario

  • Research Site - Greater Sudbury
  • Research Site - Hamilton
  • Research Site - Newmarket
  • Research Site - Toronto

Florida

  • Research Site - Fort Myers
  • Research Site - St. Petersburg
  • Research Site - Tampa

New York

  • Research Site - New Hyde Park
  • Research Site - New York
  • Research Site - The Bronx

Other

  • Research Site - Moscow
  • Research Site - Moscow
  • Research Site - Novosibirsk

Alabama

  • Research Site - Birmingham

Arizona

  • Research Site - Goodyear

Kentucky

  • Research Site - Louisville

Pennsylvania

  • Research Site - Philadelphia

Trial Details

FieldValue
Enrollment Target 154 participants
Start Date 2018-03-16
Est. Completion 2026-12-31
Phase Phase 2

Sponsor

AstraZeneca

1,285 total trials

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What the Registry Record Tells You About NCT03459846

The ClinicalTrials.gov registry entry for NCT03459846 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 154 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 305-participant average among 19 other Urinary Bladder Neoplasms trials with a reported enrollment target (50% lower). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Urinary Bladder Neoplasms appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT03459846 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Ontario, Florida, New York.

Frequently Asked Questions

What is clinical trial NCT03459846 about?

NCT03459846 is a clinical study titled "A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU)". 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

What is the current status of trial NCT03459846?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 154 participants. The study started on 2018-03-16. Estimated completion is 2026-12-31.

What conditions does trial NCT03459846 study?

This clinical trial studies the following conditions: Urinary Bladder Neoplasms.

What interventions are being tested in trial NCT03459846?

The interventions under investigation include: Placebo (DRUG), Olaparib (DRUG), Durvalumab (DRUG).

Who is sponsoring clinical trial NCT03459846?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03459846 being conducted?

This trial has 20 study locations across Alabama, Arizona, Florida, Kentucky, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.