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Bemarituzumab + Chemotherapy for Stomach Cancer (FORTITUDE-101 Trial)
FORTITUDE-101 Trial Summary
This trial is testing if adding the drug bemarituzumab to standard chemotherapy can help people with colorectal cancer live longer.
FORTITUDE-101 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowFORTITUDE-101 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.FORTITUDE-101 Trial Design
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Who is running the clinical trial?
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- My cancer is HER2 positive.I am fully active and can carry on all pre-disease activities without restriction.I can safely receive mFOLFOX6 chemotherapy.My tumor shows high FGFR2b levels based on a recent test.I have had recent eye problems, including corneal defects or a corneal transplant.I have advanced stomach or gastroesophageal cancer that cannot be removed by surgery.My blood counts and liver/kidney functions are within safe ranges for treatment.I have been treated with drugs targeting the FGF-FGFR pathway.I haven't had treatment for advanced cancer in the last 6 months.I haven't had major surgery or joined another study in the last 28 days.I have moderate to severe numbness or tingling in my hands or feet.I have long-term eye problems.I received palliative radiotherapy within the last 14 days.I haven't had any other cancers in the last 2 years, except those treated definitively.I have brain metastases that are either untreated or causing symptoms.I have a serious heart condition.
- Group 1: Bemarituzumab with mFOLFOX6
- Group 2: Placebo with mFOLFOX6
- 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
Where is this test being taken place?
"At the moment, this research is being conducted in 16sites. These include locations in Montreal, Indianapolis and Rochester as well as other cities 16 other locations. If you are considering enrolling, it might be helpful to choose the clinic nearest you to reduce travel time demands."
Are there any other similar drugs to Bemarituzumab that have been tested in clinical trials?
"Bemarituzumab was first researched in 2022 at Nacionalinis vezio institutas. Out of the 18,299 completed trials to date, 2 are ongoing with many taking place in Montreal, Quebec."
Has there been any similar research on this topic previously?
"Bemarituzumab has been studied since the year 2022, when Amgen sponsored its first Phase 3 clinical trial. 516 patients were observed in the initial study. Since then, there have been 2 more trials involving this medication which are currently taking place across 95 cities and 31 countries."
If an adult is interested in participating, are they eligible for this research?
"According to the eligibility requirements for this trial, people aged 18 to 100 may apply. There are 31 studies specifically designed for patients under 18 and 1478 trials involving participants 65 or older."
Are people able to sign up for this clinical trial at this time?
"The study, which is currently recruiting patients, was originally posted on clinicaltrials.gov on March 7th, 2022. The information hosted there was most recently updated November 9th, of the same year."
Has Bemarituzumab been given the green light by the FDA?
"Bemarituzumab is a Phase 3 trial drug, meaning that it has undergone multiple rounds of testing and there is some data supporting its efficacy. Power gave it a safety rating of 3."
How can I sign up for this clinical trial?
"This cancer treatment clinical trial has 516 available spots for patients aged 18 to 100 that have stomach cancer. Key eligibility requirements participants must meet are as follows: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times the upper limit of normal (ULN) (or less than 5 times ULN if liver involvement). Total bilirubin less than 1.5 times ULN (or less than 2 times ULN if liver involvement); with the exception of participants with Gilbert's disease), Adults with unresectable, locally advanced or metastatic gast"
How many people will be included in this experiment?
"The sponsor, Amgen, needs 516 eligible patients to run the study out of various medical facilities like Jewish General Hospital in Montreal and Saint Francis Medical Group located in Indianapolis."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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