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

Phase 2

Withdrawn

• Conditions: Colorectal Cancer Metastatic
• Interventions: Drug: Capecitabine; Drug: Aflibercept AVE0005; Drug: Oxaliplatin SR96669

• Registration Number: NCT02085005
• Lead Sponsor: Sanofi

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.

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".

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-10
• Study First Submitted QC: 2014-03-10
• Study First Posted: 2014-03-12
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-17
• Last Update Posted: 2014-11-18
• Primary Completion: 2016-08
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aflibercept	Oxaliplatin SR96669	Intravenous (IV) infusion on Day 1 every 3 weeks, followed by CAPOX (capecitabine by oral administration on Day 1 to Day 14 and oxaliplatin intravenous (IV) infusion on Day 1 every 3 weeks) for the induction treatment period (6 cycles) after which the patient may enter the maintenance period during which the treatment is Aflibercept + Capecitabine
Aflibercept	Aflibercept AVE0005	Intravenous (IV) infusion on Day 1 every 3 weeks, followed by CAPOX (capecitabine by oral administration on Day 1 to Day 14 and oxaliplatin intravenous (IV) infusion on Day 1 every 3 weeks) for the induction treatment period (6 cycles) after which the patient may enter the maintenance period during which the treatment is Aflibercept + Capecitabine
Aflibercept	Capecitabine	Intravenous (IV) infusion on Day 1 every 3 weeks, followed by CAPOX (capecitabine by oral administration on Day 1 to Day 14 and oxaliplatin intravenous (IV) infusion on Day 1 every 3 weeks) for the induction treatment period (6 cycles) after which the patient may enter the maintenance period during which the treatment is Aflibercept + Capecitabine

Primary Outcome Measures

Name	Time	Method
Progression Free Survival rate at 10 months (PFS@10m)	every 9 weeks, up to 28 months

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS) - Time	every 9 weeks, up to 28 months
Overall Survival (OS) - Time	every 9 weeks, up to 28 months
Assessment of Objective Response Rate (ORR)	every 9 weeks, up to 28 months
Total Score as a measure of Health Related Quality of Life	every 3 weeks, up to end of treatment
Number of participants with adverse events	up to 30 days after last treatment