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

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 Feb 2025 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Seoul, Republic of Korea, 03080

Location

Research Site

seoul, Republic of Korea, 06351

Location

Research Site

Seoul, Republic of Korea, 03722

Location

Research Site

Seoul, Republic of Korea, 06591

Location

Research Site

Seongnam-si, Republic of Korea, 13620

Location

Research Site

Muang, Thailand, 50200

Location

Research Site

Hat Yai, Thailand, 90110

Location

Research Site

Taipei, Taiwan, Province of China, 11217

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.

Documents available

Download
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D933AC00001&attachmentIdentifier=f0f0274f-a72a-4d83-8200-e6a74d44d8fe&fileName=D933AC00001_-___Statistical_Analysis_Plan-redact.pdf&versionIdentifier=
Download
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D933AC00001&attachmentIdentifier=88a80119-302b-4810-bce2-623ab0a77f31&fileName=d933ac00001-oncology-late-phase-master-csp-v8-redact.pdf&versionIdentifier=
Download
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D933AC00001&attachmentIdentifier=7f0ef0d5-6fe8-4acc-8de5-143b4c68c4d9&fileName=d933ac00001-study-synopsis-redact.pdf&versionIdentifier=
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Contact Backup

AstraZeneca Cancer Study Locator Service

1-877-400-4656

AstraZeneca@emergingmed.com

Investigators

Principal Investigator

Gordon Cohen

AstraZeneca

Sponsors

Collaborators

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D933AC00001&amp;attachmentIdentifier=f0f0274f-a72a-4d83-8200-e6a74d44d8fe&amp;fileName=D933AC00001_-___Statistical_Analysis_Plan-redact.pdf&amp;versionIdentifier=

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D933AC00001&amp;attachmentIdentifier=88a80119-302b-4810-bce2-623ab0a77f31&amp;fileName=d933ac00001-oncology-late-phase-master-csp-v8-redact.pdf&amp;versionIdentifier=

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D933AC00001&amp;attachmentIdentifier=7f0ef0d5-6fe8-4acc-8de5-143b4c68c4d9&amp;fileName=d933ac00001-study-synopsis-redact.pdf&amp;versionIdentifier=

Trial Results Summaries

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D933AC00001&attachmentIdentifier=f0f0274f-a72a-4d83-8200-e6a74d44d8fe&fileName=D933AC00001_-___Statistical_Analysis_Plan-redact.pdf&versionIdentifier=

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D933AC00001&attachmentIdentifier=88a80119-302b-4810-bce2-623ab0a77f31&fileName=d933ac00001-oncology-late-phase-master-csp-v8-redact.pdf&versionIdentifier=

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D933AC00001&attachmentIdentifier=7f0ef0d5-6fe8-4acc-8de5-143b4c68c4d9&fileName=d933ac00001-study-synopsis-redact.pdf&versionIdentifier=