Ignite Creation Date:
2024-05-06 @ 3:27 AM
Last Modification Date:
2024-10-26 @ 11:34 AM
Study NCT ID:
NCT02299648
Status:
COMPLETED
Last Update Posted:
2022-06-15
First Post:
2014-10-16
Brief Title:
The Screening Protocol for The VIKTORY Trial
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
Official Title:
The Screening Protocol for The VIKTORY Trial- Targeted Agent eValuation in gastrIc Cancer basKeT KORea studY SMC-AZ GC Basket Trial Screening Protocol
Status:
COMPLETED
Status Verified Date:
2022-06
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 protocol is a screening protocol only No drug intervention study will be included in this protocol However based on the molecular profiling patients may be eligible for targeted agents However the molecular profiling doesnt guarantee the enrollment onto the clinical trial Currently the available drugs are AKT inhibitor MEK inhibitor Wee1 inhibitor MET inhibitor ATR inhibitor and other agents may be available in the context of clinical trials depending on the availability
Detailed Description:
To screen metastatic GC patients who failed or progressed on first-line chemotherapy Patients will undergo biopsy of their tumor and will be analyzed using cancer panelnanostring CNV and immunohistochemistry This protocol is a screening protocol and informed consent form will be obtained again according to the biomarker profiled on this protocol if eligible Informed consent will be obtained from patients with gastric adenocarcinoma and analysis of fresh tissue or archival FFPE at Samsung Medical Center will be performed Patients who have prior to or completed or during the first-line chemotherapy fluoropyramidineplatinum-based will be eligible for screening
After the analysis pathologic and molecular biologic verification process about validity of the result will proceed The biopsies will be performed before or after or during first-line treatment for molecular analysis The patients who are screened through this protocol will undergo baseline biopsy before or after or during first-line therapy
Study Objectives
1 Primary Objective To screen metastatic GC patients who failed or progressed on first-line chemotherapy Patients will undergo biopsy of their tumor and will be analyzed using cancer panelnanostring CNV and immunohistochemistry
2 Secondary Objective
Planned subgroup analyses
1 OS biomarker negative vs biomarker postivie metastatic GC patients
2 PFS biomarker negative vs biomarker postivie metastatic GC patients
3 OSPFS EBV negative vs positive metastatic GC patients
After the analysis pathologic and molecular biologic verification process about validity of the result will proceed The biopsies will be performed before or after or during first-line treatment for molecular analysis The patients who are screened through this protocol will undergo baseline biopsy before or after or during first-line therapy
Study Objectives
1 Primary Objective To screen metastatic GC patients who failed or progressed on first-line chemotherapy Patients will undergo biopsy of their tumor and will be analyzed using cancer panelnanostring CNV and immunohistochemistry
2 Secondary Objective
Planned subgroup analyses
1 OS biomarker negative vs biomarker postivie metastatic GC patients
2 PFS biomarker negative vs biomarker postivie metastatic GC patients
3 OSPFS EBV negative vs positive metastatic GC patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None