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Nexavar® Versus Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer

NCT00984282 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 417

Last updated 2018-09-13

Study results available
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Summary

Trial of sorafenib versus placebo in the treatment of locally advanced or metastatic differentiated thyroid cancer refractory to radioiodine

Conditions

  • Thyroid Neoplasms

Interventions

DRUG

Sorafenib (Nexavar, BAY43-9006)

Sorafenib 400 mg will be administered orally, twice daily (approximately every 12 hours).

DRUG

Placebo

Placebo (2 tablets) will be administered orally, twice daily (approximately every 12 hours).

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-15
Primary Completion
2012-08-31
Completion
2017-08-30
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Bulgaria
  • China
  • Denmark
  • France
  • Germany
  • Italy
  • Japan
  • Netherlands
  • Poland
  • Russia
  • Saudi Arabia
  • South Korea
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT00984282 on ClinicalTrials.gov