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:2023-507405-34-00
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 Dec 2025
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Sept 2025 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Treatment Arm Durvalumab + Gemcitabine + Cisplatin | Drug: Durvalumab IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria. |
| Placebo Comparator: Placebo Arm Placebo + Gemcitabine + Cisplatin | Drug: Placebo IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria. |
Contacts
Investigators
Principal Investigator
Gordon Cohen
AstraZeneca
