NCT00126568

Sorafenib in Treating Patients With Advanced Anaplastic Thyroid Cancer

Phase II Trial of BAY 43-9006 in Patients With Advanced Anaplastic Carcinoma of the Thyroid

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well sorafenib works in treating patients with advanced anaplastic thyroid cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Detailed description

OBJECTIVES: I. Determine whether the objective response rate is ≥ 20% in patients with advanced anaplastic thyroid cancer treated with sorafenib. II. Determine the survival of patients treated with this drug. III. Determine the safety profile of this drug in these patients. IV. Determine the pharmacokinetic predictors of response to this drug in these patients. OUTLINE: This is a multicenter study. Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for survival.

Conditions

• Anaplastic Thyroid Cancer
• Recurrent Thyroid Cancer

Interventions

Type	Name	Description
DRUG	sorafenib tosylate	Given orally

Timeline

• Start date: 2005-06-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2005-08-04
• Last updated: 2018-01-19
• Results posted: 2012-08-10

Locations

1 site across 1 country: United States