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Tyrosine Kinase Inhibitor

Cabozantinib + TAS-102 for Colorectal Cancer

Phase 1
Waitlist Available
Led By Farshid Dayyani, MD
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the start date of treatment until 4 weeks after the last patient has started treatment, an average of 1 year.
Awards & highlights

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).

Who is the study for?
This trial is for adults with advanced colorectal cancer that's spread and can't be cured by surgery or radiation. They must have tried other treatments without success, be in fairly good health otherwise, and agree to use contraception. People who've had certain recent treatments, severe allergies to the drugs being tested, brain metastases not stable for at least 4 weeks, or uncontrolled illnesses cannot join.Check my eligibility
What is being tested?
The study tests combining Cabozantinib with TAS-102 (trifluridine/tipiracil) to find a safe dosage and see how well it works as a last-resort treatment for metastatic colorectal carcinoma (mCRC). It's an early-phase trial designed to establish safety profiles before moving on to larger trials.See study design
What are the potential side effects?
Cabozantinib may cause high blood pressure, diarrhea, weight loss, fatigue and hand-foot syndrome. TAS-102 might lead to neutropenia (low white blood cell count), fatigue, nausea and liver enzyme abnormalities. Side effects can vary from person to person.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the start date of treatment until 4 weeks after the last patient has started treatment, an average of 1 year.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start date of treatment until 4 weeks after the last patient has started treatment, an average of 1 year. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Limiting Toxicity [DLT]
Recommended Phase 2 Dose [RP2D]
Secondary outcome measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Number of Participants with Objective Response Rate
Overall Survival of Patients who Received Cabozantinib with TAS-102
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Cabozantinib in Combination with TAS-102 (trifluridine/tipiracil)Experimental Treatment2 Interventions
Subjects will receive cabozantinib in combination with TAS-102. Patients will receive cabozantinib on Days 1 - 28 and TAS-102 on Days 1-5 and Days 8-12, for a cycle length of 28 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
FDA approved
Tipiracil
FDA approved

Find a Location

Who is running the clinical trial?

University of California, IrvineLead Sponsor
542 Previous Clinical Trials
1,921,989 Total Patients Enrolled
Farshid Dayyani, MD5.02 ReviewsPrincipal Investigator - Chao Family Comprehensive Cancer Center
University of California, Irvine
5Patient Review
I'm currently enrolled in a clinical trial at UCIMC, so the Gilbert AZ is old. The chemo I'm on appears to be effective against my pancreatic cancer that has metastasized to my Omentum. Dr Sayyani does a great job adjusting the chemotherapeutic side effects increase. He listens to our questions and answers them to our satisfaction most of the time. Some things he can't answer, like "what and when is the next step in treatment?"

Media Library

Cabozantinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04868773 — Phase 1
Colorectal Cancer Research Study Groups: Cabozantinib in Combination with TAS-102 (trifluridine/tipiracil)
Colorectal Cancer Clinical Trial 2023: Cabozantinib Highlights & Side Effects. Trial Name: NCT04868773 — Phase 1
Cabozantinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04868773 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI
~3 spots leftby Apr 2025