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Efficacy of XL184 (Cabozantinib) in Advanced Medullary Thyroid Cancer

NCT00704730 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2021-04-20

Study results available
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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

Interventions

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2011-10-31
Completion
2020-09-30

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

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00704730 on ClinicalTrials.gov