CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 330 enrolled
Drug / intervention
XL184 +1 moredrug
Likely dose
Not stated in 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.

Search/NCT00704730
NCT00704730Phase 3Completed
CompareCT.gov

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

Exelixis·interventional·Posted Jun 25, 2008·Updated Apr 20, 2021

In Brief

A Phase 3 clinical trial evaluating XL184 and Placebo for Thyroid Cancer. Completed, enrolled 330 participants across 113 sites in 24 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThyroid Cancer
CountriesAustria, 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, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 25, 2008
Enrollment StartJun 1, 2008
Primary CompletionOct 1, 2011
Study CompletionSep 1, 2020
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 18.0 years ago

Interventions

XL184drug

Gelatin capsules supplied in 25-mg and 100-mg strengths administered orally daily

Placebodrug

Gelatin capsules color and size-matched to XL184 capsules administered orally daily