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

Study Name
Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1) (TOPAZ-1)
ClinicalTrials.gov Identifier (if applicable)
NCT03875235
Clinical Trial Category (check all that apply)
  • First Line Therapy
  • Chemotherapy
  • Immunotherapy
Study Center
Institution Name
AstraZeneca
State
– Please Select –
Country
United States
Study Contacts
Principal Investigator
AstraZeneca Clinical Study Information Center
P.I. Phone
(877) 240-9479
P.I. Email
information.center@astrazeneca.com
List additional Principal Investigators (include phone number and email)
Please refer to Clinicaltrial.gov and contact AstraZeneca Cancer Study Locator Service (1-877-400-4656 AstraZeneca@emergingmed.com)
Study Coordinator
TBD
Study Coordinator Phone
(000) 000-0000
Study Coordinator Email
TBD@AZ.com
List additional Study Coordinators (include phone number and email)
Please refer to Clinicaltrial.gov and contact AstraZeneca Cancer Study Locator Service (1-877-400-4656 AstraZeneca@emergingmed.com)
OVERVIEW – in layman’s terms (150 words max)
This is a Phase III Study of Durvalumab (Immunotherapy) in Combination With Gemcitabine Plus Cisplatin Versus Placebo in Combination With Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers. Chemotherapy (Gemcitabine plus Cisplatin) is the standard of care for advanced biliary tract cancer.
Enrollment
474
Study Start Date
04/16/2019
Estimated Completion Date
03/25/2022
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
  • The purpose of the study is to find out if durvalumab (immunotherapy) in combination with gemcitabine plus cisplatin will work for the treatment of advanced biliary tract cancers.
Inclusion Criteria – Patients Must:
  • Histologically confirmed, unresectable advanced or metastatic biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.
  • Patients with preciously untreated disease if unresectable or metastatic at initial diagnosis will be eligible.
  • 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.
  • WHO/ECOG PS of 0 or 1
Exclusion Criteria – Patients Must NOT:
  • History of another primary malignancy
  • Brain metastases or spinal cord compression
  • Uncontrolled intercurrent illness
  • Major surgical procedure within 28 days prior to the first dose of IP
  • Prior locoregional therapy such as radioembolization
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