NCT01930552

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

A Phase I Study of the Safety, Tolerability, and Pharmacokinetics of Aflibercept in Combination With FOLFIRI Administrated Every 2 Weeks in Chinese Patients With Advanced Solid Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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".

Conditions

• Neoplasm Malignant

Interventions

Type	Name	Description
DRUG	Aflibercept AVE0005	Pharmaceutical form:Solution for infusion Route of administration: Intravenous
DRUG	Leucovorin	Pharmaceutical form:Solution for infusion Route of administration: Intravenous
DRUG	Irinotecan	Pharmaceutical form:Solution for infusion Route of administration: Intravenous
DRUG	5-Fluorouracil	Pharmaceutical form:Solution for infusion Route of administration: Intravenous

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2013-08-29
• Last updated: 2015-01-07

Locations

2 sites across 1 country: China