Ignite Creation Date:
2024-05-06 @ 2:21 PM
Last Modification Date:
2024-10-26 @ 1:30 PM
Study NCT ID:
NCT04298008
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2020-02-25
Brief Title:
AZD6738 Plus Durvalumab in Biliary Tract Cancer
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
Official Title:
Combination of AZD6738 Plus Durvalumab in Refractory Biliary Tract Cancer in Patients Who Have Failed Immunotherapy
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial will enroll advanced biliary tract cancer patients who have been previously treated with immunotherapy in either the 2nd or 3rd line
Patients will be treated with AZD6738 and Durvalumab combination
Patients will be treated with AZD6738 and Durvalumab combination
Detailed Description:
This is a single arm phase II study Advanced BTC patients who have been previously treated with immunotherapy in either the 2nd or 3rd line will be enrolled
Patients will be treated with AZD6738 and Durvalumab combination
One cycle consists of 4weeks Response evaluation will be done every 8 weeks every 2 cycles of treatment
1 Tumor biopsy is mandatory screening after 8weeks 1st-response evaluation at disease progression PD
2 blood sampling for biomarker study is mandatory every cycles
3 To evaluate the metabolic changes by AZD6738 and Durvalumab combination 18 F-FDG PET is mandatory screening after 8 weeks 1st-response evaluation
Patients will be treated with AZD6738 and Durvalumab combination
One cycle consists of 4weeks Response evaluation will be done every 8 weeks every 2 cycles of treatment
1 Tumor biopsy is mandatory screening after 8weeks 1st-response evaluation at disease progression PD
2 blood sampling for biomarker study is mandatory every cycles
3 To evaluate the metabolic changes by AZD6738 and Durvalumab combination 18 F-FDG PET is mandatory screening after 8 weeks 1st-response evaluation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None