Ignite Creation Date:
2024-05-06 @ 1:30 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01822444
Status:
COMPLETED
Last Update Posted:
2023-04-06
First Post:
2013-02-25
Brief Title:
ANGIOPREDICT ICORG 12-16 V3
Sponsor:
Cancer Trials Ireland
Organization:
Cancer Trials Ireland
Study Overview
Official Title:
Exploratory Phase II Clinical Trial Comprising Biomarker Analysis of Oxaliplatin Plus FluorouracilLeucovorin FOLFOX in Combination With Bevacizumab Bvz in First Line Treatment of Metastatic Colorectal Cancer CRC Expressing Mutant K-ras - AC-ANGIOPREDICT
Status:
COMPLETED
Status Verified Date:
2023-04
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:
Primary Objective
The primary objective is to validate previously identified predictiveprognostic genomic DNA and expression biomarkers of response to combination bvz treatments in K-ras mutant advanced CRC a CRC or metastatic CRC mCRC
Secondary Objective
1 To test the efficacy of bvz in combination with FOLFOX in patients with newly diagnosed advanced or metastatic K-ras mutant CRC and
2 To determine the progression free and overall survival of patients under first line FOLFOX bvz in aCRC or mCRC
The primary objective is to validate previously identified predictiveprognostic genomic DNA and expression biomarkers of response to combination bvz treatments in K-ras mutant advanced CRC a CRC or metastatic CRC mCRC
Secondary Objective
1 To test the efficacy of bvz in combination with FOLFOX in patients with newly diagnosed advanced or metastatic K-ras mutant CRC and
2 To determine the progression free and overall survival of patients under first line FOLFOX bvz in aCRC or mCRC
Detailed Description:
Study Design
Type of Study Exploratory translational multicenter and multinational Phase II study
Patient PopulationAll patients from the intent-to-treat population with aCRC or mCRC incurable with any conventional multimodality approach and who fulfil all inclusion and exclusion criteria
Number of Patients 224
Sample Type
Serial tissue and blood samples will be collected before week 0 during week 6 month 3 and 6 and at the end of treatment month 12
Type of Study Exploratory translational multicenter and multinational Phase II study
Patient PopulationAll patients from the intent-to-treat population with aCRC or mCRC incurable with any conventional multimodality approach and who fulfil all inclusion and exclusion criteria
Number of Patients 224
Sample Type
Serial tissue and blood samples will be collected before week 0 during week 6 month 3 and 6 and at the end of treatment month 12
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