drugset
drugset / Trial / NCT01930552

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

NCT01930552 ↗

Phase 1 Completed 20 enrolled Sanofi Regeneron Pharmaceuticals · collab
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2013-09
Primary completion
2014-12
Completion
2014-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Aflibercept Protein / enzyme biologic — Intravenous
Background Irinotecan Small molecule — Intravenous
Background Leucovorin Small molecule — Intravenous
Background fluorouracil Small molecule — Intravenous

Indications

cancer