This study is in progress, not accepting new patients

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

a study on Biliary Tract Cancer

Summary

Eligibility
for people ages 18-130 (full criteria)
Location
at UC Irvine
Dates
study started
study ends around
Principal Investigator
by Farshid Dayyani (uci)

Description

Summary

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

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

Details

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.

Keywords

Biliary Tract Neoplasms, First-Line Advanced Biliary Tract Cancers (BTC), Durvalumab, Gemcitabine/Cisplatin, Placebo

Eligibility

For people ages 18-130

Inclusion

  1. Histologically confirmed, unresectable advanced or metastatic biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.
  2. Patients with previously untreated disease if unresectable or metastatic at initial diagnosis will be eligible.
  3. Patient with recurrent disease >6 months after curative surgery or >6 months after the completion of adjuvant therapy (chemotherapy and/or radiation) will be eligible.
  4. WHO/ECOG PS of 0 or 1

Exclusion

  1. History of another primary malignancy
  2. Brain metastases or spinal cord compression
  3. Uncontrolled intercurrent illness
  4. Major surgical procedure within 28 days prior to the first dose of IP.
  5. Prior locoregional therapy such as radioembolization

Locations

  • Research Site
    Los Angeles California 90027 United States
  • Research Site
    Orange California 92868 United States

Lead Scientist at University of California Health

  • Farshid Dayyani (uci)
    Clinical Professor, Medicine, School of Medicine. Authored (or co-authored) 134 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AstraZeneca
Links
Redacted CSR synopsis final Redacted SAP Redacted CSP final
ID
NCT03875235
Phase
Phase 3 Biliary Tract Cancer Research Study
Study Type
Interventional
Participants
About 810 people participating
Last Updated