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NCT03875235 · ClinicalTrials.gov record · last posted 2026-08-26

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

Study acronym: TOPAZ-1
StatusActive, Not Recruiting
PhasePhase 3
Started2019-04-16
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1).

Amendment record 49 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 49 times since 2019-03-13; most recent amendment 2026-05-21. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2022-01-12
Status change Recruiting→Active, Not Recruitingv31
2019-05-06
Status change Not Yet Recruiting→Recruitingv1
Trial Details
NCT Number NCT03875235
Lead Sponsor AstraZeneca
Conditions Biliary Tract Neoplasms
Enrollment 810 participants
Start Date 2019-04-16
Primary Completion 2021-08-11 (estimated)
Study Completion 2027-05-16 (estimated)
Updated on ClinicalTrials.gov 2026-08-26