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Onvansertib + FOLFIRI + Bevacizumab for Colorectal Cancer
Study Summary
This trial is testing a new cancer drug to see if it is safe and effective when used with other drugs to treat metastatic colorectal cancer.
- Metastatic Colorectal Cancer
- KRAS Mutation
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 1 & 2 trial • 72 Patients • NCT03303339Trial Design
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Who is running the clinical trial?
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- You are 18 years old or older.You have agreed to participate in the study and have signed a document saying so.You are not currently receiving any other cancer treatments except for non-interventional surveys or observational studies.You have had cancer in the past, except for certain types.You have a medical condition that could make it unsafe for you to take the study drug, or that could make it difficult for you to receive treatment.Your organs must be functioning properly.You have an ongoing illness that is not being properly managed.You have a noticeable buildup of fluid in your abdomen or lungs.You have already received and did not respond well to the chemotherapy drugs fluoropyrimidine and oxaliplatin, with or without bevacizumab, or you experienced side effects that made it hard to continue the treatment.You cannot or do not want to swallow the study medication.You have advanced colorectal cancer that cannot be removed by surgery.You have a specific mutation in your Kras gene that has been confirmed by a certified laboratory. If you have a mutation in both Kras and BRAF-V600 genes or Microsatellite Instability High/Deficient Mismatch Repair (MSI-H/ddMMR), you cannot participate in this study.Your tumor tissue must be available for testing. If there is no existing sample, you will need to have a biopsy taken during screening.You should be able to perform your daily activities without much difficulty.You have received treatment for your cancer within the past 6 months, but you cannot have any treatment for 4 weeks before starting this study.You must have received chemotherapy treatment that includes a drug called oxaliplatin, with or without bevacizumab, for at least 6 weeks. If you received maintenance therapy with fluoropyrimidines, you may still be eligible with or without re-challenge with oxaliplatin in combination with fluoropyrimidines.If you have rectal cancer, receiving both pre-treatment and post-treatment will be considered as one treatment for advanced cancer.If you had to stop your first treatment because of side effects, you can still participate as long as your disease got worse less than 6 months after stopping that treatment.
- Group 1: Onvansertib + FOLFIRI + Bevacizumab
- 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
Is this medical research currently recruiting participants?
"At this time, the trial is not currently enrolling participants. It was initially published on May 6th 2019 and most recently amended on November 10th 2022. However, there are plenty of other options available; 882 trials for metastatic colorectal cancer (CRC) patients need help and 792 studies require individuals taking Onvansertib to join them in the research effort."
What is the size of the participant pool for this experiment?
"Unfortunately, this experiment is not currently accepting participants. It was first listed on May 6th 2019 and the record was most recently amended November 10th 2022. If you seek other research opportunities related to metastatic colorectal cancer (crc), there are 882 studies that may be suitable for your needs; Additionally 792 trials require volunteers for their Onvansertib clinical trial."
How many locations are included in the scope of this clinical trial?
"7 clinical sites are presently enrolling participants for this trial. Patients can choose from Rochester, Los Angeles, Phoenix and 4 other locations to minimize travel demands when participating in the study."
What pathologies does Onvansertib have a proven efficacy against?
"Onvansertib is a viable therapeutic option for patients suffering from rectal carcinoma, colorectal carcinoma and sarcoma."
Could you elucidate which other experiments have utilized Onvansertib?
"Currently, there are 212 studies investigating Onvansertib in Phase 3 with a total of 792 live trials. Most have been launched from Shanghai but trials can be found at 37411 medical locations world-wide."
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