At a glance
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A Single-Arm Phase II Study in Japan to Assess the Efficacy and Safety of Aflibercept Administered Every Two Weeks in Combination With FOLFIRI in Patients With Metastatic Colorectal Cancer Who Progressed During or Following an Oxaliplatin-Based Regimen
In Brief
A Phase 2 clinical trial evaluating Aflibercept, Levofolinate, and 2 other interventions for Colorectal Cancer Metastatic. Completed, enrolled 62 participants across 19 sites.
Detailed Summary
Primary Objective: To assess efficacy aflibercept + 5-fluorouracil (5-FU)/levofolinate/irinotecan (FOLFIRI) by objective response rate (ORR). Secondary Objective: To assess the following: * safety profile; * progression free survival (PFS); * overall survival (OS); * pharmacokinetics (PK); * immunogenicity.
Study Details
Timeline
Interventions
Pharmaceutical form: Concentrated solution (100 mg/4 mL \[25 mg/mL\], 200 mg/8 mL \[25 mg/mL\]) for infusion; Route of administration: Intravenous
Pharmaceutical form: Solution for infusion (marketed formulation); Route of administration: Intravenous
Pharmaceutical form: Solution for infusion (marketed formulation); Route of administration: Intravenous
Pharmaceutical form: Solution for infusion (marketed formulation); Route of administration: Intravenous