This is an uncontrolled, open-label, non-randomized phase I / pharmacokinetic study of oral BAY86-9766 to investigate the safety, tolerability, pharmacokinetics, and efficacy profiles in Japanese patients with advanced solid tumors
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
BAY86-9766 30 mg twice a day (bid).
BAY86-9766 50 mg twice a day (bid).
BAY86-9766 100 mg once a day (od)
Unnamed facility
Kashiwa, Chiba, Japan
Safety evaluation due to results of physical examinations, vital signs, AEs, abnormal laboratory tests and 12-lead ECG, cardiac function test and ophthalmological examination.
Time frame: At the end of 30-day follow up after discontinuation of study drug administration
Calculation of pharmacokinetic parameters of BAY86-9766 and its metabolite (M17).
Time frame: Cycle 1 Day 22 and Day 23 for Cohorts 1 & 2 and Cohorts 3 & 4, respectively.
Response rate
Time frame: On average 3 months
Disease control rate
Time frame: On average 3 months
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BAY86-9766 60 mg once a day (od)