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

Study identifier:D933AC00001

ClinicalTrials.gov identifier:NCT03875235

EudraCT identifier:2018-004688-30

CTIS identifier:N/A

Recruitment Complete

Official Title

A Phase III Randomized, Double-Blind Placebo Controlled, Multi-Regional, International Study of Durvalumab in Combination with Gemcitabine Plus Cisplatin Versus Placebo in Combination with Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers

Medical condition

Biliary Tract Neoplasms

Phase

Phase 3

Healthy volunteers

No

Study drug

Durvalumab, Placebo

Sex

All

Actual Enrollment

810

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 16 Apr 2019
Primary Completion Date: 11 Aug 2021
Estimated Study Completion Date: 31 Mar 2025

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria