A Phase I Study of Aflibercept Plus FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) in Chinese Patients With Advanced Solid Malignancies

Phase 1

Completed

• Conditions: Neoplasm Malignant
• Interventions: Drug: Aflibercept AVE0005; Drug: Leucovorin; Drug: Irinotecan; Drug: 5-Fluorouracil

• Registration Number: NCT01930552
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

To assess the safety and pharmacokinetics preliminarily of the dose of intravenous (IV) aflibercept used in western studies in combination with FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) given intravenously every 2 weeks in Chinese patients with solid tumors.

Secondary Objectives:

* To make a preliminary assessment of antitumor effects of the combination of FOLFIRI plus aflibercept in patients with measurable disease (RECIST 1.1).

* To evaluate the immunogenicity of IV aflibercept.

Detailed Description

Total duration of the study per patient is in the range of 17 to 29 weeks.

This trial is being conducted in China, 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 First Submitted: 2013-08-14
• Study First Submitted QC: 2013-08-22
• Study First Posted: 2013-08-29
• Study Start: 2013-09
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-06
• Last Update Posted: 2015-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 1	Irinotecan	aflibercept IV infusion for 1 hour followed by FOLFIRI IV infusion every 2 weeks
Cohort 1	Leucovorin	aflibercept IV infusion for 1 hour followed by FOLFIRI IV infusion every 2 weeks
Cohort 1	Aflibercept AVE0005	aflibercept IV infusion for 1 hour followed by FOLFIRI IV infusion every 2 weeks
Cohort 1	5-Fluorouracil	aflibercept IV infusion for 1 hour followed by FOLFIRI IV infusion every 2 weeks

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics: Assessment of plasma concentrations of aflibercept, CPT-11 (irinotecan) and Fluorouracil (5-FU)	Up to last aflibercept administration + 90 days
Number of patients with standard safety assessments (adverse events and laboratory tests)	Up to last treatment + 30 days

Secondary Outcome Measures

Name	Time	Method
Anti-aflibercept antibody detection	Up to last aflibercept administration + 90 days
Anti-tumor activity assessment - duration response	Up to 17 Weeks
Anti-tumor activity assessment - overall response rate	Up to 17 Weeks

Trial Locations

Locations (2)

Investigational Site Number 156002; 🇨🇳 Beijing, China

Investigational Site Number 156001; 🇨🇳 Guangzhou, China