Ignite Creation Date:
2024-05-06 @ 2:21 PM
Last Modification Date:
2024-10-26 @ 1:30 PM
Study NCT ID:
NCT04298021
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2020-02-25
Brief Title:
DDR-Umbrella Study of DDR Targeting Agents in Advanced Biliary Tract Cancer
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
Official Title:
DDR-Umbrella Study of DDR DNA-Damage Response Targeting Agents in Advanced Biliary Tract Cancer
Status:
ACTIVE_NOT_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:
To assess the effect of AZD6738 and Durvalumab combination or AZD6738 and Olaparib combination in biliary tract cancer patients who have failed to 1st-line chemotherapy
Detailed Description:
This is a open-label phase II umbrella study enrolling advanced biliary tract cancer patients who have failed to 1st-line chemotherapy Patients will be enrolled to AZD6738 and Durvalumab combination or AZD6738 and Olaparib combination cohorts Based on the new emerging therapies cohorts can be added into existing protocol
1 AZD6738 Durvalumab cohort
Durvalumab 1500 mg iv on D1
AZD6738 240 mg bid on D15-D28 Every 4 weeks C1D1 dose of durvalumab will be delivered and AZD6738 of 240 mg bid will be dosed at D15-D28 Every cycle consists of 4 weeks
2 AZD6738 Olaparib cohort
AZD6738 160 mg qd on D1-D7
Olaparib 300 mg bid on D1-D28 Every 4 weeks Every cycle consists of 4 weeks AZD6738 of 160 mg qd will be administered on D1-D7 Olaparib will be delivered as 300 mg bid dose on D1-D28
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 18 F-FDG PET is mandatory at screening and after 8 weeks 1st-response evaluation
1 AZD6738 Durvalumab cohort
Durvalumab 1500 mg iv on D1
AZD6738 240 mg bid on D15-D28 Every 4 weeks C1D1 dose of durvalumab will be delivered and AZD6738 of 240 mg bid will be dosed at D15-D28 Every cycle consists of 4 weeks
2 AZD6738 Olaparib cohort
AZD6738 160 mg qd on D1-D7
Olaparib 300 mg bid on D1-D28 Every 4 weeks Every cycle consists of 4 weeks AZD6738 of 160 mg qd will be administered on D1-D7 Olaparib will be delivered as 300 mg bid dose on D1-D28
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 18 F-FDG PET is mandatory at screening and 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