A global, randomized, placebo-controlled phase 3 study of fruquintinib in patients with refractory metastatic colorectal cancer

Interventions: Safety Lead-in Cohort: Fruquintinib will be administered 5 mg orally QD 3 weeks on/1 week off for every 4-
week treatment cycle
Main study: Fruquintinib (or Placebo) capsule 5 mg will be administered PO, QD, 3 weeks on, 1 week off (4-week cycles).
Primary outcome(s): Safety Lead-in Cohort: evaluation of the safety and tolerability of fruquintinib in Japanese patients with mCRC by assessing treatmentemergent adverse events, serious adverse events (SAEs), dose-limiting toxicities (DLTs), deaths, laboratory abnormalities, and other safety data.
Main study: OS, defined as the time (months) from date of randomization to death from any cause.
Study Design: randomized controlled trial, double blind, placebo control, parallel assignment, treatment purpose