The main purpose of this study is to determine if AZD8931 can be safely administered in Japanese patients alone and in combination with weekly paclitaxel. The study will be conducted in two parts: a monotherapy and a combination part, where safe doses of study treatment will be determined.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Tablet Oral bid
IV once weekly for 3 weeks followed by a week off
Research Site
Osaka, Japan
Monotherapy part: Assessment of adverse events, laboratory findings, physical examination, vital signs, ECG/UCG, chest X-ray, HRCT, SpO2 and ophthalmological examinations.
Time frame: Full routine safety assessment on days 1-4, 8, 10, 14, 21, 28 then every 3 weeks after first dose of study drug
Combination part: The contents of same assessment as Monotherapy.
Time frame: Full routine safety assessment on days 1-5, 8, 15, 22, 28 then every 4 weeks after first dose of study drug
Combination Part: Pharmacokinetics of AZD8931 (tmax, Cmax, AUC0-10)
Time frame: On Day D7 and Day D8: pre-dose then, 1, 2, 4, 6, 8 and 10 hours post dose
Combination Part: Pharmacokinetics of paclitaxel (tmax, Cmax, AUC0-10)
Time frame: On Days D1 and Day D8: pre-infusion then, 0.5, 1, 1.5, 2, 4, 6, 8, 10 and 24 (D1 only) hours post start of infusion
Monotherapy Part: Pharmacokinetics of AZD8931 (Single dose plasma PK: AUC0-10, AUC0-12, AUC0-24, AUC0-t, AUC, Cmax, tmax, t1/2, CL/F, Vss/F. Multiple dose plasma PK: AUCss0-10, AUCss0-12, Cssmax, tssmax, Cssmin, CLss/F, RAC, linearity factor)
Time frame: On single dose Day 1 (D1) and multiple dose Day 21 (R14): samples taken pre-dose then 1, 2, 4, 6, 8, 10, 24 (D1 only), 48 (D1 only) and 72 (D1 only) hours post dose. Day 10 (R3) and Day 14 (R7): pre-dose only
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