Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-01-04 @ 9:35 AM
Study NCT ID:
NCT02085005
Status:
WITHDRAWN
Last Update Posted:
2014-11-18
First Post:
2014-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Capecitabine Plus Aflibercept as Maintenance Therapy Following Capecitabine Plus Oxaliplatin Plus Aflibercept in Patients With Metastatic Colorectal Cancer
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
Phase II Study of First-line Capecitabine Plus Oxaliplatin Plus Aflibercept for 6 Cycles Followed by Capecitabine Plus Aflibercept as Maintenance Therapy in Patients With Metastatic Colorectal Cancer: DROP and GO Trial
Status:
WITHDRAWN
Status Verified Date:
2014-11
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:
Drop and Go
Brief Summary:
Primary Objective:
Efficacy: To assess the progression-free survival rate at 10 months in patients on maintenance therapy with capecitabine plus aflibercept.
Secondary Objectives:
To evaluate:
* Efficacy: Progression Free Survival (PFS)
* Efficacy: Overall Survival (OS)
* Efficacy: Objective Response Rate (ORR) as per Response Evaluation Criteria In Solid Tumors (RECIST version 1.1) criteria
* Health related Quality of Life (HRQL): EORTC QLQ-C30 scores and EQ5D-3L
* Safety
Exploratory Objective:
To collect blood and tumor samples to perform investigations for potential biomarker testing.
Efficacy: To assess the progression-free survival rate at 10 months in patients on maintenance therapy with capecitabine plus aflibercept.
Secondary Objectives:
To evaluate:
* Efficacy: Progression Free Survival (PFS)
* Efficacy: Overall Survival (OS)
* Efficacy: Objective Response Rate (ORR) as per Response Evaluation Criteria In Solid Tumors (RECIST version 1.1) criteria
* Health related Quality of Life (HRQL): EORTC QLQ-C30 scores and EQ5D-3L
* Safety
Exploratory Objective:
To collect blood and tumor samples to perform investigations for potential biomarker testing.
Detailed Description:
Total study duration for a participant can be up to 28 months.
This trial is being conducted in countries where the INN designation for the study molecule is "aflibercept" and this term is therefore used throughout the synopsis. In the US, the US proper name is "ziv-aflibercept".
This trial is being conducted in countries where the INN designation for the study molecule is "aflibercept" and this term is therefore used throughout the synopsis. In the US, the US proper name is "ziv-aflibercept".
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1149-0237 | OTHER | UTN | View |