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Cabozantinib + TAS-102 for Colorectal Cancer
Study Summary
This trial is testing a new cancer drug, cabozantinib, to see if it is safe to use with another cancer drug, trifluridine/tipiracil (TAS102).
Timeline
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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- You are expected to live for at least 3 more months.You are taking certain medications that thin your blood.You cannot be taking any other experimental drugs.You have been treated with cabozantinib before.You have shown severe allergic reactions to any of the medications used in the study, or you have a rare condition that affects your ability to digest certain sugars.You have cancer that has spread or come back and cannot be treated with surgery or radiation to cure it.You have already received or had side effects from certain cancer drugs like fluoropyrimidine, irinotecan, oxaliplatin, and cetuximab or panitumumab (only for RAS wild-type). You may have also received bevacizumab or ramucirumab. If you have tried all other treatments available, you may also be eligible.You are able to swallow pills.You have experienced allergic reactions to drugs that are similar to TAS-102 or cabozantinib.You have an ongoing health condition that is not being properly managed.You have had another type of cancer within the past 3 years, except for non-melanoma skin cancer, early-stage prostate cancer, or successfully treated cervical cancer.
- Group 1: Cabozantinib in Combination with TAS-102 (trifluridine/tipiracil)
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- 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 clinical research still recruiting participants?
"Affirmative. According to clinicaltrials.gov, this medical research is currently recruiting patients who meet the requirements of the trial. It was initially posted on July 16th 2021 and most recently updated October 31st 2022 - with a goal of enrolling 12 subjects at one site."
Has the FDA sanctioned Cabozantinib for use in patients?
"Cabozantinib's safety rating is assessed at 1 due to the fact that this trial only entered its initial phase, thus providing limited evidence of both efficacy and safety."
What conditions may be treated with Cabozantinib?
"Cabozantinib is frequently employed to treat individuals who have already had oxaliplatin chemotherapy. It can also be applied to high risk patients, those previously exposed to anti-VEGF medication, and renal cell carcinoma cases."
Could I become a participant in this trial if I meet the criteria?
"This medical trial is enrolling 12 patients between 18 and 100 years of age who have been diagnosed with colorectal cancer. Additionally, they must be RAS wild-type (with the exception of those treated with panitumumab or cetuximab), experienced progression following a fluoropyrimidine, irinotecan, oxaliplatin treatment regime, possibly received prior Bevacizumab or Ramucirumab treatments, possess an Eastern Cooperative Oncology Group performance status less than 2 according to Appendix A guidelines and display a life expectancy greater than 3 months."
Is Cabozantinib featured in any additional research projects?
"Currently, there are 151 active clinical trials utilizing Cabozantinib, 15 of which are in Phase 3. Despite the majority being situated in Cordoba and Calabria, a total of 7375 sites have been established for this medication's testing."
What is the current capacity for participants in this experiment?
"Affirmative, according to clinicaltrials.gov, this research endeavour is actively enrolling volunteers; the study was introduced on July 16th 2021 and recently updated on October 31st 2022. 12 individuals need to be registered from one medical facility for the trial's completion."
Has this clinical trial been conducted before?
"Since 2012, Cabozantinib has been the subject of medical research with its earliest study sponsored by Exelixis. This first trial was successful enough to garner Phase 2 drug approval and now there are 151 active trials for this medication conducted in 48 countries across 1435 cities."
Is the age requirement for this research limited to those over 20 years old?
"This medical investigation is open to patients who are between 18 and 100 years old."
What aims are these researchers hoping to achieve with this research endeavor?
"The primary endpoint of this medical trial is the Dose Limiting Toxicity [DLT], which will be observed over a period of one year, beginning at the start date of treatment and ending four weeks after the last patient has started their own. Secondary outcomes include an evaluation of safety and tolerability using NCI's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0., overall survival rates among patients who received cabozantinib with TAS-102, as well as objective response rate (ORR) based on Response Evaluation Criteria In Solid Tumors Version 1.1 (REC"
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