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NCT03875235 · ClinicalTrials.gov registry record · Phase 3

Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)

A Phase 3 study of Biliary Tract Neoplasms, sponsored by AstraZeneca.

Active
Registry status
Phase 3
Development phase
810
Enrollment target
20
Study locations

NCT03875235 is a Phase 3 study of Biliary Tract Neoplasms that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 810 participants, above the 316-participant average among 6 other Biliary Tract Neoplasms trials with a reported enrollment target (156% higher). The trial reports 20 study locations across 13 states.

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The verdict

NCT03875235, a Phase 3 study of Biliary Tract Neoplasms, is active but no longer recruiting, sponsored by AstraZeneca.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
810 participants
Enrollment target
20
Study locations

Study Summary

Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1).

Conditions Studied

Biliary Tract Neoplasms

Interventions

  • DRUG Placebo
  • DRUG Durvalumab

Study Locations (20)

Other

  • Research Site - Buenos Aires
  • Research Site - CABA
  • Research Site - CABA
  • Research Site - Ciudad de Buenos Aires
  • Research Site - Ciudad de Buenos Aires

California

  • Research Site - Los Angeles
  • Research Site - Orange

Florida

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

Tennessee

  • Research Site - Chattanooga
  • Research Site - Nashville

District of Columbia

  • Research Site - Washington D.C.

Kansas

  • Research Site - Westwood

Kentucky

  • Research Site - Louisville

Massachusetts

  • Research Site - Burlington

Trial Details

FieldValue
Enrollment Target 810 participants
Start Date 2019-04-16
Est. Completion 2027-05-16
Phase Phase 3

Sponsor

AstraZeneca

1,285 total trials

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What the Registry Record Tells You About NCT03875235

The ClinicalTrials.gov registry entry for NCT03875235 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 810 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 316-participant average among 6 other Biliary Tract Neoplasms trials with a reported enrollment target (156% higher). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Biliary Tract Neoplasms appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT03875235 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Other, California, Florida.

Frequently Asked Questions

What is clinical trial NCT03875235 about?

NCT03875235 is a clinical study titled "Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)". Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1).

What is the current status of trial NCT03875235?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 810 participants. The study started on 2019-04-16. Estimated completion is 2027-05-16.

What conditions does trial NCT03875235 study?

This clinical trial studies the following conditions: Biliary Tract Neoplasms.

What interventions are being tested in trial NCT03875235?

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

Who is sponsoring clinical trial NCT03875235?

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

Where is trial NCT03875235 being conducted?

This trial has 20 study locations across California, District of Columbia, Florida, Kansas, Kentucky. 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.