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

• Status: Withdrawn
• Trial end date: 2016-08-01

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.

• Phase: Phase 2

Details

• Lead Sponsor: Sanofi
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Aflibercept; Capecitabine; Oxaliplatin