Phase II Trial of BAY 43-9006 in Patients With Advanced Anaplastic Carcinoma of the Thyroid
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients With Response to Treatment Measured by RECIST Criteria
Response evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. The patient's best response depends on the achievement of measurement and confirmation criteria of Complete Response (CR), Stable Disease (SD), Partial Response (PR) or Progressive Disease (PD). Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques (CT, MRI, x-ray) or as >10 mm with spiral CT scan.
at 6 months after treatment
Case Western Reserve University
United States: Food and Drug Administration
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