A Phase I Study of Aflibercept Plus FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) in Chinese Patients With Advanced Solid Malignancies
- Conditions
- Neoplasm Malignant
- Interventions
- 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".
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Not provided
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
Investigational Site Number 156002🇨🇳Beijing, China