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Trial Summary

This is a global, randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial to compare the efficacy and safety of fruquintinib plus best supportive care (BSC) versus placebo plus BSC in patients with refractory metastatic colorectal cancer (mCRC). 687 subjects will be randomized to one of the following treatment arms in a 2:1 ratio, fruquintinib plus BSC or placebo plus BSC.

Acronym:

FRESCO-2

ACTRN/NCT /ethics:

NCT04322539

Scientific title:

A Global Multicenter Randomized Placebo-Controlled Phase 3 Trial To Compare The Efficacy And Safety Of Fruquintinib Plus Best Supportive Care To Placebo Plus Best Supportive Care In Patients With Refractory Metastatic Colorectal Cancer

Sponsor / Cooperative group:

Hutchison Medipharma Limited

Trial & Patient Characteristics

Cancer TypeBowel and colon
Trial TypeTreatment
PhasePhase III
Age Range18 years and older
SexBoth
Tumour Stream -
Cancer StageMetastatic or Widespread
Anticipated Start Date2020-07-10
Anticipated End Date2022-07-01

Participating Hospitals

HospitalThe Queen Elizabeth Hospital
Clinical Trial CoordinatorPamela Cooper
EmailPamela.cooper@sa.gov.au
Phone08 8222 6140
Principal InvestigatorDr Timothy Price
Recruitment StatusRecruiting
HospitalFlinders Medical Centre
Clinical Trial CoordinatorHannah Adelson
EmailHannah.adelson@sa.gov.au
Phone08 8206 4835
Principal InvestigatorProfessor Chris Karapetis
Recruitment StatusRecruiting