drugset / Trial / NCT02085005

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

NCT02085005

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2014-03
Primary completion
2016-08
Completion
2016-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Aflibercept Protein / enzyme biologic Intravenous
Subject Capecitabine Small molecule Oral
Subject Oxaliplatin Small molecule Intravenous

Indications