Cabozantinib (XL184) for Medullary Thyroid Cancer
(EXAMINER Trial)
Recruiting in Palo Alto (17 mi)
+45 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Waitlist Available
Sponsor: Exelixis
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?
The objective of this study is to evaluate the efficacy and safety of oral cabozantinib at a 60 mg dose compared with a 140 mg dose in subjects with progressive, metastatic MTC. It will test if the lower dose results in similar progression free survival (PFS) and overall response rate (ORR) with fewer adverse events compared to the PFS, ORR and adverse events found in previous clinical trials of 140 mg.
Research Team
Eligibility Criteria
Inclusion Criteria
The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document.
The subject has recovered to baseline or CTCAE v4.0 ≤ Grade 1 from toxicities related to any prior treatments, unless AE(s) are clinically non-significant and/or stable on supportive therapy.
You have been diagnosed with MTC through a tissue sample.
See 6 more
Exclusion Criteria
Receipt of any other type of investigational agent within 28 days of randomization.
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.
The subject has uncontrolled, significant intercurrent illness including, but not limited to, cardiovascular disorders, gastrointestinal disorders, active infections, non-healing wounds, recent surgery.
See 10 more
Treatment Details
Interventions
- Cabozantinib (XL184) (Tyrosine Kinase Inhibitor)
Participant Groups
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Exelixis
Lead Sponsor
Trials
126
Recruited
20,500+
Michael M. Morrissey
Exelixis
Chief Executive Officer since 2010
PhD in Chemistry from Harvard University, BSc in Chemistry from the University of Wisconsin
Vicki L. Goodman
Exelixis
Chief Medical Officer since 2022
MD
Related Searches
By Condition