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Trametinib + Trifluridine/Tipiracil for Colorectal Cancer
Study Summary
This trialtests a new combo of drugs to treat advanced colorectal cancer, to find the best dose and any side effects.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have a history of Gilbert's syndrome.You cannot have had or currently have any other type of cancer, except for a few specific cases.You are not required to have had prior treatment with bevacizumab or regorafenib, as some patients are not suitable for this type of therapy and may not have received these drugs before.You have a condition that affects your digestive system such as stomach ulcers, severe nausea, vomiting, diarrhea, or if you have had a part of your small intestine removed.You are allergic to any of the ingredients in the study drugs.You had a bad reaction to a medication called fluoropyrimidine in the past.You have already been treated with a MEK inhibitor or TAS-102 therapy in the past.You cannot be taking any experimental drugs not yet approved by regulatory agencies.You cannot take any growth factor medication for 14 days before the ANC assessment, unless your low blood cell count is caused by your illness.If the investigator thinks it's not safe for you to participate in the study due to any health issues, like infections, blockages, difficulty swallowing pills, or mental health concerns, you will not be able to join the study.
- Group 1: Treatment (TAS-102, trametinib)
- 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
Has there been prior experimentation with TAS-102 and trametinib in a clinical setting?
"Currently, 134 clinical trials focusing on Treatment (TAS-102, trametinib) are being conducted. Of those, 10 have reached Phase 3 status. Lakewood in New jersey is the primary centre of these studies; however 6313 other medical centres are also running trials for this drug combination treatment."
Are there any US facilities which have been certified to administer this clinical investigation?
"There are currently 8 clinical trial sites that are administering this medical study. These locations range from South Pasadena to West Covina, and Duarte with other destinations in between. To reduce travel commitments, it is recommended to select the closest site possible."
Is there availability for volunteers to participate in this research project?
"This trial is no longer in the recruitment phase. It was initially posted on April 11th, 2018 and its last update occurred on October 26th, 2022. If you are seeking out other studies to join, there are currently 3657 studies searching for patients with metastatic colorectal carcinoma and 134 trials looking at TAS-102 or trametinib that have open enrollment slots available."
What maladies can be ameliorated through the application of TAS-102 and trametinib?
"TAS-102 and trametinib are frequently prescribed to treat ocular vaccinia infection. Additionally, these medications have been proven effective for managing metastatic melanoma as well as for those that were previously treated with oxaliplatin chemotherapy or anti-vegf treatments."
How many participants are being welcomed into this medical trial?
"Unfortunately, this trial is no longer accepting participants at this time. It was initially posted in April 2018 and the last edit occurred on October 26th 2022. However, if you are seeking out other research studies, there are presently 3657 trials searching for those with metastatic colorectal carcinoma and 134 clinical studies exploring Treatment (TAS-102, trametinib) actively recruiting patients."
Has the FDA given its authorization for TAS-102 and trametinib as viable therapies?
"Limited evidence of the safety and efficacy of Treatment (TAS-102, trametinib) leads to it being estimated a score of 1."
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