At a glance
ClinicalIndex Comparison RecordPhase 4Active· 247 enrolled
Drug / intervention
Cabozantinib (XL184) 140 mg +3 moredrug
Likely dose
Cabozantinib (XL184) 140 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Cabozantinib (XL184) 140 mg, Cabozantinib (XL184) 60 mg, and 2 other interventions for Medullary Thyroid Cancer. Active but no longer recruiting, targeting 247 participants across 49 sites in 14 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMedullary Thyroid Cancer
CountriesAustralia, Canada, Croatia, France, Hungary, Israel, Italy, Netherlands, Poland, Romania, Russia, South Korea, Spain, Sweden
Collaborators--
Timeline
Phase 4Active
20132014201520162017201820192020202120222023202420252026202720282029203020312032203320342035
First PostedJul 2013
Enrollment StartFeb 2015
Primary CompletionJul 2020
TodayJul 2026
Study CompletionJan 2035
First PostedJul 11, 2013
Enrollment StartFeb 25, 2015
Primary CompletionJul 15, 2020
Study CompletionJan 1, 2035
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 13.0 years ago
Interventions
Cabozantinib (XL184) 140 mgdrug
Cabozantinib (XL184) 60 mgdrug
Placebo tabletdrug
Placebo capsuledrug