The objectives of this study are to evaluate safety, efficacy and pharmacokinetics of sorafenib for the treatment of Japanese patients with anaplastic thyroid carcinoma (ATC) or locally advanced or metastatic medullary thyroid carcinoma (MTC).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Sorafenib 400 mg will be administered orally,twice daily in a 28 day cycle
Unnamed facility
Kobe, Hyōgo, Japan
Unnamed facility
Matsumoto, Nagano, Japan
Unnamed facility
Bunkyo-ku, Tokyo, Japan
Unnamed facility
Koto-ku, Tokyo, Japan
Unnamed facility
Osaka, Japan
Number of subjects with adverse events and serious adverse events as a measure of safety and tolerability
Time frame: 6 months
Change in red blood cell count
Time frame: Baseline and 6 months
Change in white blood cell count
Time frame: Baseline and 6 months
Change in alanine aminotransaminase level (ALT)
Time frame: Baseline and 6 months
Change in aspartate aminotransferase level (AST)
Time frame: Baseline and 6 months
Change in blood pressure
Time frame: Baseline and 6 months
Best overall response based on RECIST 1.1 criteria
Time frame: Baseline and every 56 days up to progressive disease,an expected average of 8 months
Plasma concentration of sorafenib
Time frame: Cycle 2 Day 1
Progression-free survival (PFS)
Time frame: Baseline to progression or death by any reason
Overall survival (OS)
Time frame: Baseline to death by any reason
Response rate (RR)
RR based on RECIST 1.1 criteria
Time frame: Baseline and every 56 days up to progressive disease
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Disease control rate (DCR)
DCR based on RECIST 1.1 criteria
Time frame: Baseline and every 56 days up to progressive disease
Maximum reduction from baseline in the target lesion size
Time frame: Baseline and every 56 days up to progressive disease
Maximum percentage change of calcitonin and Carcinoembryonic antigen (CEA) values from baseline
MTC subjects only
Time frame: Baseline and every 56 days up to progressive disease