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NCT02546661 · ClinicalTrials.gov registry record · Phase 1

Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Phase 1b Study in Pts w/ Muscle Invasive Bladder Cancer

A Phase 1 study of Muscle-invasive Bladder Cancer, sponsored by AstraZeneca.

Active
Registry status
Phase 1
Development phase
117
Enrollment target
20
Study locations

NCT02546661 is a Phase 1 study of Muscle-invasive Bladder Cancer that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 117 participants, below the 1,324-participant average among 10 other Muscle-invasive Bladder Cancer trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT02546661, a Phase 1 study of Muscle-invasive Bladder Cancer, is active but no longer recruiting, sponsored by AstraZeneca.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
117 participants
Enrollment target
20
Study locations

Study Summary

This is an open label, multi-drug, biomarker-directed, multi-centre, multi-arm, Phase 1b study in patients with muscle invasive bladder cancer (MIBC) (urothelial) who have progressed on prior treatment. This study is modular in design, allowing evaluation of the safety, tolerability, pharmacokinetics and anti-tumour activity of multiple agents as monotherapy and as combinations of different novel anti-cancer agents. The study will consist of a number of study modules (sub-studies), each evaluating the safety and tolerability of a specific agent or combination.

Conditions Studied

Muscle-invasive Bladder Cancer

Interventions

  • DRUG Olaparib
  • DRUG AZD1775
  • DRUG AZD4547
  • DRUG MEDI4736
  • DRUG Vistusertib

Study Locations (20)

Other

  • Research Site - Bordeaux
  • Research Site - Caen
  • Research Site - Lyon
  • Research Site - Marseille
  • Research Site - Saint-Herblain
  • Research Site - Toulouse
  • Research Site - Badalona
  • Research Site - Barcelona

New York

  • Research Site - New York
  • Research Site - New York
  • Research Site - New York

California

  • Research Site - Los Angeles

Connecticut

  • Research Site - New Haven

Florida

  • Research Site - Fort Myers

Ohio

  • Research Site - Cleveland

Tennessee

  • Research Site - Nashville

Alberta

  • Research Site - Edmonton

Trial Details

FieldValue
Enrollment Target 117 participants
Start Date 2016-12-28
Est. Completion 2026-01-30
Phase Phase 1

Sponsor

AstraZeneca

1,285 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02546661

The ClinicalTrials.gov registry entry for NCT02546661 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 117 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,324-participant average among 10 other Muscle-invasive Bladder Cancer trials with a reported enrollment target (91% lower). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Muscle-invasive Bladder Cancer appearing as the primary indexed condition, and to 5 interventions - of which Olaparib is the first listed.

NCT02546661 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Other, New York, California.

Frequently Asked Questions

What is clinical trial NCT02546661 about?

NCT02546661 is a clinical study titled "Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Phase 1b Study in Pts w/ Muscle Invasive Bladder Cancer". This is an open label, multi-drug, biomarker-directed, multi-centre, multi-arm, Phase 1b study in patients with muscle invasive bladder cancer (MIBC) (urothelial) who have progressed on prior treatment. This study is modular in design, allowing evaluation of the safety, tolerability, pharmacokinetic...

What is the current status of trial NCT02546661?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 117 participants. The study started on 2016-12-28. Estimated completion is 2026-01-30.

What conditions does trial NCT02546661 study?

This clinical trial studies the following conditions: Muscle-invasive Bladder Cancer.

What interventions are being tested in trial NCT02546661?

The interventions under investigation include: Olaparib (DRUG), AZD1775 (DRUG), AZD4547 (DRUG), MEDI4736 (DRUG), Vistusertib (DRUG).

Who is sponsoring clinical trial NCT02546661?

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

Where is trial NCT02546661 being conducted?

This trial has 20 study locations across California, Connecticut, Florida, New York, Ohio. 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.