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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.

Compiled by PlainTrial · August 8, 2026

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

NCT03875235: Active Phase 3 study of Biliary Tract Neoplasms, sponsored by AstraZeneca.

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. According to ClinicalTrials.gov, the official US trial registry.

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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).

Primary Outcome

Overall Survival (OS) was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. The second interim analysis was pre-specified after approximately 397 OS events occurred in both arms (59% maturity).

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

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

AstraZeneca

1,285 total trials

What the registry record for NCT03875235 still lists

NCT03875235 is an interventional study that assigns participants to a tested intervention. The registered 810 participants enrollment target is mid-sized for trials with a published cap, above the 316-participant average among 6 other Biliary Tract Neoplasms trials with a reported enrollment target (156% higher).

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 names 20 study sites across 13 states, led by 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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Source: ClinicalTrials.gov NCT03875235, the US trial registry maintained by the National Library of Medicine. NCT03875235 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.