A Phase Ib Study of Humanized Anti-VEGF Monoclonal Antibody (Sevacizumab) Injection Plus FOLFIRI in Chinese Patients With Metastatic Colorectal Cancer

  • STATUS
    Not Recruiting
  • participants needed
    36
  • sponsor
    Jiangsu Simcere Pharmaceutical Co., Ltd.
Updated on 21 January 2021
measurable disease
vegf
fluorouracil
kidney function tests
metastasis
oxaliplatin
liver metastasis
leucovorin
irinotecan
bevacizumab
aptt
vascular endothelial growth factor
folfiri regimen

Summary

This is an open-label, multicenter, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of Humanized Anti-VEGF Monoclonal Antibody (Sevacizumab) Injection in combination with FOLFIRI in patients with previously treated metastatic colorectal cancer. This study includes two stages. Stage 1 is the dose-escalation stage. Once the maximum tolerated dose (MTD) of Sevacizumab has been established, additional patients will be enrolled in the cohort-expansion stage (Stage 2).

Details
Condition Metastatic Colorectal Cancer
Treatment Irinotecan, 5-FU, Leucovorin, Sevacizumab
Clinical Study IdentifierNCT02453464
SponsorJiangsu Simcere Pharmaceutical Co., Ltd.
Last Modified on21 January 2021

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