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Fruquintinib for Colorectal Cancer (FRESCO-2 Trial)
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.
FRESCO-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowFRESCO-2 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.FRESCO-2 Trial Design
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Who is running the clinical trial?
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- 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.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Frequently Asked Questions
What has been the mortality rate for patients who have taken fruquintinib in addition to receiving the best care possible?
"Fruquintinib has received a score of 3 for safety by our analysts at Power. This is because fruquintinib is in Phase 3 of clinical trials, meaning that there is some data supporting both efficacy and safety."
Is this particular type of medical research popular in Canada?
"This clinical trial is based in four states: Florida, Tennessee, California, and Texas. More specifically, the trial is taking place at Florida Cancer Specialists North in Saint Petersburg, Florida, Florida Cancer Specialists WPB in West Palm Beach, Tennessee, and Texas Oncology El Paso - Grandview in El Paso, California."
What other research has looked at the effectiveness of adding fruquintinib to standard medical care?
"The efficacy of fruquintinib in combination with best supportive care was first explored in 2017 at Mayo Clinic Rochester. As of now, a total of 18278 similar studies have been completed. 23 more trials are currently recruiting patients, many of which are based in Saint Petersburg, Florida."
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