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Tyrosine Kinase Inhibitor
Cabozantinib (XL184) for Medullary Thyroid Cancer (EXAMINER Trial)
Phase 4
Waitlist Available
Research Sponsored by Exelixis
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 up to 31 months
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
Summary
This trial will compare the effectiveness of two doses of a drug for people with a certain type of cancer that has spread.
Eligible Conditions
- Medullary Thyroid Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 31 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 31 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression Free Survival
Secondary study objectives
Objective Response Rate
Other study objectives
Safety and tolerability of cabozantinib as assessed by adverse events.
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cabozantinib (XL184) 60 mgExperimental Treatment2 Interventions
Cabozantinib (XL184) 60 mg as tablets and placebo capsules administered orally once a day.
Group II: Cabozantinib (XL184) 140 mgExperimental Treatment2 Interventions
Cabozantinib (XL184) 140 mg as capsules and placebo tablets administered orally once a day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo capsule
2015
Completed Phase 4
~5340
Placebo tablet
2020
Completed Phase 4
~6240
Find a Location
Who is running the clinical trial?
ExelixisLead Sponsor
120 Previous Clinical Trials
19,883 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with another type of cancer within the past 2 years, except for certain types of skin cancer or tumors that have been successfully treated without needing medication.You have been diagnosed with MTC through a tissue sample.Everyone in the study needs to be checked for a specific mutation called RET. If you don't have a test result for this mutation, a sample of your tumor will be tested.You have taken cabozantinib before.Your heart's electrical activity, measured by the QT interval, is too long.You have a detectable and spreading disease as confirmed by recent imaging tests.Your condition has gotten worse in recent scans compared to scans taken within the last 14 months.You have taken certain types of medications within a specific time period before joining the study.You have received any cancer treatment within the last 28 days (or 42 days for specific types of treatment).You have received radiation treatment within a certain time period before the start of the study, or if you are still experiencing problems from previous radiation treatment.You have untreated or active cancer that has spread to your brain.You are currently taking blood thinners or medication that prevents blood clotting.
Research Study Groups:
This trial has the following groups:- Group 1: Cabozantinib (XL184) 140 mg
- Group 2: Cabozantinib (XL184) 60 mg
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
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.
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