Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04751955
Status:
WITHDRAWN
Last Update Posted:
2023-10-31
First Post:
2021-02-04
Brief Title:
A Phase lbll Open Label Single Arm Study With Olinvacimab and Capecitabine in mCRC Patients OLCAP
Sponsor:
Korean Cancer Study Group
Organization:
Korean Cancer Study Group
Study Overview
Official Title:
A Phase lbll Multicenter Open Label Single Arm Study to Assess the Safety and Efficacy of the Anti-VEGFR2 Monoclonal Antibody Olinvacimab and the Capecitabine in Patients With mCRC Who Failed Two Prior Chemotherapies
Status:
WITHDRAWN
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This clinical trial was not finally approved by the Korea FDA
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim on this study is to assess the safety and efficacy of the anti-VEGFR2 monoclonal antibody olinvacimab and the capecitabine in patients with metastatic colorectal carcinoma who failed two prior chemotherapies
Detailed Description:
This is a phase lbll multicenter open label single arm study to assess efficacy and safety of the anti-VEGFR2 monoclonal antibody olinvacimab and capecitabine in patients with metastatic colorectal cancer who failed two prior standard chemotherapies
The primary objective of phase lb is to determine maximal tolerated dose MTD and recommended phase ll dose RP2D of olinvacimab in combination with capecitabine the primary objective of phase ll is to assess the efficacy of olinvacimab plus capecitabine as a salvage regimen in metastatic colorectal carcinoma
The primary objective of phase lb is to determine maximal tolerated dose MTD and recommended phase ll dose RP2D of olinvacimab in combination with capecitabine the primary objective of phase ll is to assess the efficacy of olinvacimab plus capecitabine as a salvage regimen in metastatic colorectal carcinoma
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