NCT02085005

Capecitabine Plus Aflibercept as Maintenance Therapy Following Capecitabine Plus Oxaliplatin Plus Aflibercept in Patients With Metastatic Colorectal Cancer

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• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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".

Conditions

• Colorectal Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Capecitabine	Pharmaceutical form:tablet Route of administration: oral
DRUG	Aflibercept AVE0005	Pharmaceutical form:concentrate for infusion Route of administration: intravenous
DRUG	Oxaliplatin SR96669	Pharmaceutical form:solution for infusion Route of administration: intravenous

Timeline

• Start date: 2014-03-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2014-03-12
• Last updated: 2014-11-18