Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06642844
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-03-08
Brief Title:
Bevacizumab-based Chemotherapy Adapted to Bevacizumab Pharmacokinetics in 1st-line Treatment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Bevacizumab-based Chemotherapy Tailored to the Pharmacokinetics of Bevacizumab in First-line Treatment of Unresectable Metastatic Colorectal Cancer a Randomized Multicenter Double-blind Phase 3 Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PHARBEVACOL
Brief Summary:
Bevacizumab is a standard drug for metastatic colorectal cancer mCRC in combination with cytotoxic chemotherapy However inter-individual pharmacokinetic variability was observed for bevacizumab and an exposure-response relationship for efficacy was described for bevacizumab in mCRC patients treated with 1st-line bevacizumab-based chemotherapy
Detailed Description:
The primary objective is to evaluate the effect of doubling the dose of bevacizumab in mCRC patients whose initial serum bevacizumab concentration is 155 mgL on progression-free survival PFS
This project is a multicenter double-blind randomized trial in two parallel groups
The primary endpoint is progression-free survival PFS
This project is a multicenter double-blind randomized trial in two parallel groups
The primary endpoint is progression-free survival PFS
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