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Tyrosine Kinase Inhibitor
Fruquintinib for Colorectal Cancer (FRESCO-2 Trial)
Phase 3
Waitlist Available
Research Sponsored by Hutchison Medipharma Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥18 years
Histologically and/or cytologically documented metastatic colorectal adenocarcinoma. RAS, BRAF, and microsatellite instability (MSI)/mismatch repair (MMR) status for each patient must be documented according to country level guidelines
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 42 months
Awards & highlights
FRESCO-2 Trial Summary
This trial is testing a new cancer drug to see if it is more effective and has fewer side effects than the current standard of care for people with metastatic colorectal cancer.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects for Fruquintinib aren't listed here, similar medications often cause symptoms like fatigue, nausea, diarrhea, low blood cell counts increasing infection risk, liver issues, mouth sores, loss of appetite and weight changes.
FRESCO-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My colorectal cancer is confirmed by tests and I know my RAS, BRAF, and MSI/MMR status.
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My body weight is at least 40kg.
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I am fully active or can carry out light work.
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I agree to use effective birth control and an additional barrier method during and after the study.
FRESCO-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 42 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 42 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS)
Secondary outcome measures
Change From Baseline in EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Health Utility Index Scores
Change From Baseline in EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life (QOL) Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life Scale Score
+11 moreFRESCO-2 Trial Design
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fruquintinib
2021
Completed Phase 3
~1680
Find a Location
Who is running the clinical trial?
Hutchison Medipharma LimitedLead Sponsor
100 Previous Clinical Trials
12,858 Total Patients Enrolled
William Schelman, MD, PhDStudy DirectorHUTCHMED International Corporation
2 Previous Clinical Trials
160 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have not had bleeding from any site in the last 2 months.I have had a blood clot in the past 6 months.I received radiation for bone cancer less than 2 weeks ago.I have not had brachytherapy in the last 60 days.I haven't had a live vaccine in the last 28 days.I haven't had surgery or a biopsy in the last 60 days, except for a central venous catheter placement.My kidney function is below normal levels.I have had other cancers, but they were treated over 5 years ago, except for certain skin, cervical, or bladder cancers.I am 18 years old or older.My blood pressure is controlled and below 140/90 mm Hg with medication.My blood clotting tests are higher than normal, but I am on or will be on blood thinners for prevention.I am not pregnant or breastfeeding.I have previously taken fruquintinib.I cannot take pills due to swallowing problems or stomach issues.I haven't had cancer treatments like chemotherapy or immunotherapy in the last 4 weeks.My cancer has spread to a major blood vessel.I am HIV positive.I have a BRAF-mutant tumor and have been treated with a BRAF inhibitor, if it was available.I don't have severe side effects from past cancer treatments, except for possible hair loss or mild nerve issues.I am currently receiving IV antibiotics for an uncontrolled infection.I have brain or spinal metastases not treated with surgery/radiotherapy and not stable for 14+ days.My colorectal cancer is confirmed by tests and I know my RAS, BRAF, and MSI/MMR status.My body weight is at least 40kg.I am not taking any medications known to affect heart rhythm.My bilirubin levels are higher than normal, but I may have Gilbert syndrome.I haven't had stomach ulcers, bleeding, or other serious gut issues in the last 6 months.I have hepatitis with undetectable viral load under treatment.I haven't taken strong CYP3A4 drugs in the last 2 weeks or more.I have MSI-H or dMMR tumors and have been treated with immune checkpoint inhibitors, if available.My cancer can be measured by scans and hasn't been treated with radiation unless it's grown.I am fully active or can carry out light work.My cancer returned within 6 months after oxaliplatin treatment, or I've had oxaliplatin for metastatic cancer if it returned later.I haven't taken any targeted cancer drugs within the last 4 weeks or 5 half-lives, whichever is shorter.I have a heart condition that affects its electrical activity or a family history of similar issues.My urine tests show high protein levels.I've had treatments with specific drugs for my cancer and they didn't work or caused side effects.I agree to use effective birth control and an additional barrier method during and after the study.
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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