Fruquintinib for Colorectal Cancer
(FRESCO-2 Trial)

Recruiting in Palo Alto (17 mi)

+167 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Hutchison Medipharma Limited

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests fruquintinib, a drug that blocks signals making cancer cells grow, in patients with advanced colorectal cancer who haven't responded to other treatments. Fruquintinib is a drug that blocks signals making cancer cells grow and has shown significant benefits in previous trials for certain types of lung cancer. It aims to find new options for those whose cancer continues to progress despite other treatments.

Eligibility Criteria

This trial is for adults over 18 with metastatic colorectal cancer who've already tried certain treatments like TAS-102 or regorafenib, and standard therapies including chemotherapy and biological therapy. They must weigh at least 40kg, have a performance status of 0-1 indicating they are fully active or restricted in physically strenuous activity but ambulatory, and be expected to live more than 12 weeks.

Inclusion Criteria

I am 18 years old or older.

Expected survival >12 weeks

I have a BRAF-mutant tumor and have been treated with a BRAF inhibitor, if it was available.

+9 more

Exclusion Criteria

My blood counts are low and I haven't had a transfusion to improve them in the last week.

I do not have serious heart problems or recent heart surgery.

I have had a stroke or a mini-stroke in the last year.

+30 more

Participant Groups

The study tests the effectiveness and safety of Fruquintinib plus best supportive care (BSC) compared to a placebo plus BSC in patients with refractory metastatic colorectal cancer. Participants are randomly assigned in a 2:1 ratio to either receive Fruquintinib or a placebo.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Fruquintinib Plus Best Supportive Care (BSC) GroupExperimental Treatment1 Intervention

Participants will be orally administered Fruquintinib 5 mg in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break (with each cycle length of 28 days).

Group II: Placebo Plus BSC GroupPlacebo Group1 Intervention

Participants will be orally administered Placebo 5 mg in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break (with each cycle length of 28 days).