NCT01955629

Study of Aflibercept as Maintenance Therapy Following Induction With Aflibercept in Combination With XELOX, as First-Line Treatment for Metastatic Colorectal Cancer Patient

A Single-Arm, Open Label Study of Aflibercept as Maintenance Therapy Following Induction With Aflibercept in Combination With XELOX, as First-Line Treatment for Metastatic Colorectal Cancer Patient

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objectives: Study Part 1: To determine the recommended dose for the aflibercept, oxaliplatin and capecitabine (XELOX) combination to be used in the Part 2 of the study. Study Part 2: To assess the percentage of participants without progression of the disease at 6 months after the start of maintenance therapy with aflibercept single-agent, following the first-line induction therapy with XELOX and aflibercept combination in participants with previously untreated metastatic colorectal cancer. Secondary Objective: Study Part 2: Include the evaluation of progression free survival, overall survival, response to treatment, the overall safety (during induction and maintenance therapy) and the assessment of aflibercept pharmacodynamics and biomarkers parameters.

Detailed description

The duration of the study for each participant includes a period for screening of up to 3 weeks, study drug administrations every 3 weeks up to disease progression, unacceptable toxicity or participant's refusal of further study treatment, followed by a minimum of 30-day follow-up after the last study treatment administration. After study treatment discontinuation each participant will be followed-up until death, participant's refusal or end of study (whichever comes first). This trial is being conducted in Europe, 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	Aflibercept AVE0005	Pharmaceutical form: Concentrate for solution for infusion; Route of administration: Intravenous
DRUG	Oxaliplatin	Pharmaceutical form: Concentrate for solution for infusion; Route of administration: Intravenous
DRUG	Capecitabine	Pharmaceutical form: Tablets; Route of administration: Oral

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2013-10-07
• Last updated: 2016-04-18
• Results posted: 2016-04-18

Locations

2 sites across 1 country: Italy