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

NCT02085005 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2014-11-18

No results posted yet for this study

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.

Conditions

  • Colorectal Cancer Metastatic

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2016-08-31
Completion
2016-08-31

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Entities

Drugs
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02085005 on ClinicalTrials.gov