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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
Approved for 10 Other Conditions
No Placebo-Only Group
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.
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.
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the start date of treatment until 4 weeks after removal of treatment due to disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the start date of treatment until 4 weeks after removal of treatment due to disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dose Limiting Toxicity [DLT]
Recommended Phase 2 Dose [RP2D]
Secondary study objectives
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 moreAwards & Highlights
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.
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
566 Previous Clinical Trials
1,933,036 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Cabozantinib in Combination with TAS-102 (trifluridine/tipiracil)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- 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.