NCT01896479

A Study of Two Different Doses of Cabozantinib (XL184) in Progressive, Metastatic Medullary Thyroid Cancer

A Randomized, Double-blind Study To Evaluate the Efficacy and Safety of Cabozantinib (XL184) at 60 mg/Day Compared to a 140 mg/Day in Progressive, Metastatic Medullary Thyroid Cancer Patients

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 247 (actual)
• Sponsor: Exelixis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Medullary Thyroid Cancer

Interventions

Type	Name	Description
DRUG	Cabozantinib (XL184) 140 mg
DRUG	Cabozantinib (XL184) 60 mg
DRUG	Placebo tablet
DRUG	Placebo capsule

Timeline

• Start date: 2015-02-25
• Primary completion: 2020-07-15
• Completion: 2035-01-01
• First posted: 2013-07-11
• Last updated: 2025-09-02
• Results posted: 2025-09-02

Locations

49 sites across 14 countries: Australia, Canada, Croatia, France, Hungary, Israel, Italy, Netherlands, Poland, Romania, Russia, South Korea, Spain, Sweden