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A Phase Ib, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of Humanized Anti-VEGF Monoclonal Antibody(Sevacizumab) Injection Plus FOLFIRI in Chinese Patients With Metastatic Colorectal Cancer

Trial Profile

A Phase Ib, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of Humanized Anti-VEGF Monoclonal Antibody(Sevacizumab) Injection Plus FOLFIRI in Chinese Patients With Metastatic Colorectal Cancer

Status: Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Sevacizumab (Primary) ; Fluorouracil; Folinic acid; Irinotecan
  • Indications Colorectal cancer
  • Focus Adverse reactions
  • Sponsors Jiangsu Simcere Pharmaceutical
  • Most Recent Events

    • 05 Jun 2018 Up to January 18, 2018, 3 patients of 2mg/kg dose group are still on treatment as per results presented at the 54th Annual Meeting of the American Society of Clinical Oncology
    • 05 Jun 2018 The study was designed to assess the doses of 3, 4, and 5 mg/kg. Since high frequency and severity of proteinuria in the patients treated with sevacizumab was observed, the protocol was amended in the expansion phase to add 2 additional dose groups (2mg/kg and 1mg/kg) and these two dose groups can be directly expanded to 8-12 patients as per results presented at the 54th Annual Meeting of the American Society of Clinical Oncology
    • 05 Jun 2018 Status changed to active, no longer recruiting as per results presented at the 54th Annual Meeting of the American Society of Clinical Oncology
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