| 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
|
