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Amivantamab + Chemotherapy for Colorectal Cancer (OrigAMI-1 Trial)
OrigAMI-1 Trial Summary
This trial will test if a new drug, called amivantamab, can help treat people with metastatic colorectal cancer. Researchers will also look at how safe amivantamab is and what the best dose of amivantamab is when it is combined with other chemotherapy drugs.
OrigAMI-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowOrigAMI-1 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.OrigAMI-1 Trial Design
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Who is running the clinical trial?
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- My cancer has a specific mutation identified through a blood test.I am fully active or restricted in physically strenuous activity but can do light work.I have been diagnosed with a type of colon or rectal cancer that cannot be removed by surgery.I am not pregnant, breastfeeding, or planning to become pregnant and agree to regular pregnancy tests.I have a history of cancer spreading to the lining of my brain and spinal cord.My cancer can be measured or seen on scans.I agree to have a biopsy of my tumor as required by the study.I have brain metastasis that is causing symptoms or hasn't been treated.
- Group 1: Cohorts Ph1b-E and E: Amivantamab+5-Fluorouracil, Leucovorin, and Irinotecan (FOLFIRI)
- Group 2: Cohorts Ph1b-D and D: Amivantamab+5-Fluorouracil, Leucovorin, and Oxaliplatin (mFOLFOX6)
- Group 3: Cohorts A, B, and C: Amivantamab Monotherapy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are there numerous medical facilities in the US conducting this research study?
"This study is recruiting participants from 21 different healthcare facilities, including the Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center in New york City, Princess Margaret Cancer Centre University Health Network in Toronto, and Stephenson Cancer Center of Oklahoma City."
What objectives is this medical research attempting to meet?
"This trial, which will be monitored for a span of up to 4 years and 3 months, seeks to measure the incidence of Adverse Events among participants. Secondary objectives include tracking vital signs abnormalities (temperature, heart rate etc.), laboratory value aberrations (serum chemistry etc.) as well as grading severity levels of adverse effects according to NCI CTCAE's version 5.0 scale that ranges from mild (Grade 1) to death-related occurrences (Grade 5)."
Is enrollment still open for this medical experiment?
"As evidenced by clinicaltrials.gov, this research endeavour is actively seeking participants since its inception on July 29th 2022 and last update November 3rd 2022."
What is the aggregate count of participants in this research?
"To complete this clinical trial, 225 individuals fitting the established inclusion criteria must participate. Potential enrollees can join at Herbert Irving Comprehensive Cancer Center and Columbia University Medical Center in New york City or Princess Margaret Cancer Centre University Health Network in Toronto."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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