Ignite Creation Date:
2024-05-06 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 12:48 PM
Study NCT ID:
NCT03579784
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2018-06-19
Brief Title:
Biomarker-oriented Study of Durvalumab MEDI4736 in Combination With Olaparib and Paclitaxel in Gastric Cancer
Sponsor:
Do-Youn Oh
Organization:
Seoul National University Hospital
Study Overview
Official Title:
Biomarker-oriented Study of Durvalumab MEDI4736 in Combination With Olaparib and Paclitaxel in Gastric 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:
Research Hypothesis The dynamics of immune systems by Olaparib and its changes by combination with immune-oncology agents will be uncovered
The combination of Olaparib with Durvalumab with paclitaxel is tolerable and efficacious in gastric cancer
Objectives
Primary Objectives
To assess the effect of Durvalumab in combination with olaparib and paclitaxel on DCR Disease control rate in gastric cancer patients
-Disease control rate based on RECIST v11
Secondary Objectives
Efficacy overall response rate RECIST 11 ir response progression-free survival duration of response overall survival overall survival at 6 month overall survival at 1 year EORTC QLQ-C30
Safety toxicity CTCAE V41 irAE
The combination of Olaparib with Durvalumab with paclitaxel is tolerable and efficacious in gastric cancer
Objectives
Primary Objectives
To assess the effect of Durvalumab in combination with olaparib and paclitaxel on DCR Disease control rate in gastric cancer patients
-Disease control rate based on RECIST v11
Secondary Objectives
Efficacy overall response rate RECIST 11 ir response progression-free survival duration of response overall survival overall survival at 6 month overall survival at 1 year EORTC QLQ-C30
Safety toxicity CTCAE V41 irAE
Detailed Description:
None
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