A Randomized, Double-blind and Placebo-controlled Phase III Trial Comparing Fruquintinib Efficacy and Safety vs Best Support Care (BSC) in Advanced Colorectal Cancer Patients Who Have Failed at Least Second Lines of Chemotherapies

Trial Profile

A Randomized, Double-blind and Placebo-controlled Phase III Trial Comparing Fruquintinib Efficacy and Safety vs Best Support Care (BSC) in Advanced Colorectal Cancer Patients Who Have Failed at Least Second Lines of Chemotherapies

Completed
Phase of Trial: Phase III

Latest Information Update: 05 Sep 2018

At a glance

  • Drugs Fruquintinib (Primary)
  • Indications Colorectal cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms FRESCO
  • Sponsors Hutchison MediPharma
  • Most Recent Events

    • 05 Sep 2018 Based on the data from this study, fruquintinib capsules have been granted approval for drug registration by the National Medical Products Administration of China (NMPA) for the treatment of metastatic colorectal cancer patients, who have failed at least two prior systemic antineoplastic therapies including fluoropyrimidine, oxaliplatin and irinotecan, with or without prior use of anti-vascular endothelial growth factor or anti-epidermal growth factor receptor therapies.
    • 31 Aug 2018 Biomarkers information updated
    • 27 Jul 2018 According to a Chi-Med media release, the company is aiming to receive NDA approval in the second half of 2018 for the treatment of patients with advanced colorectal cancer.
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