NCT00704730

Efficacy of XL184 (Cabozantinib) in Advanced Medullary Thyroid Cancer

An International, Randomized, Double-Blinded, Phase 3 Efficacy Study of XL184 Versus Placebo in Subjects With Unresectable, Locally Advanced, or Metastatic Medullary Thyroid Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 330 (actual)
• Sponsor: Exelixis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to evaluate the progression-free survival (PFS) with XL184 as compared with placebo (an inactive substance) in subjects with unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC). Subjects will be randomized to receive XL184 or placebo in a 2:1 ratio. XL184 is an investigational drug that inhibits VEGFR2, MET and RET, kinases implicated in tumor formation, growth and migration. The Clinical Steering Committee for this study, comprised of study doctors who specialize in medullary thyroid cancer, has provided guidance regarding the design of the study. The committee includes: Douglas Ball, MD, Barry Nelkin, PhD, Martin Schlumberger, MD and Steven Sherman, MD.

Conditions

• Thyroid Cancer

Interventions

Type	Name	Description
DRUG	XL184	Gelatin capsules supplied in 25-mg and 100-mg strengths administered orally daily
DRUG	Placebo	Gelatin capsules color and size-matched to XL184 capsules administered orally daily

Timeline

• Start date: 2008-06-01
• Primary completion: 2011-10-01
• Completion: 2020-09-01
• First posted: 2008-06-25
• Last updated: 2021-04-20
• Results posted: 2014-09-09

Locations

113 sites across 24 countries: United States, Austria, Belgium, Brazil, Canada, Chile, Denmark, France, Germany, Greece, India, Israel, Italy, Netherlands, Peru, Poland, Portugal, Russia, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, United Kingdom