The primary objective of this study is to assess the safety and pharmacokinetics of linifanib, and identify tolerable dose of linifanib (ABT-869) in combination with carboplatin and paclitaxel in Japanese subjects with advanced or metastatic non-small cell lung cancer (NSCLC). Secondary objective is to obtain a preliminary efficacy of anti-tumor activity in the subjects as first-line treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Low dose linifanib (once a day)
High dose linifanib (once a day)
Given on Day 1 of every 21-day cycle
Safety (Number of patients with adverse events and/or dose-limiting toxicities)
Evaluation of vital signs, physical exams, clinical lab testing and adverse event monitoring.
Time frame: At each treatment visit (weekly for 6 weeks, then every 3 weeks)
Preliminary tumor response
Computed Tomography (CT) scan
Time frame: Week 6
Preliminary tumor response
Computed Tomography (CT) scan
Time frame: Week 12
Preliminary tumor response
Computed Tomography (CT) scan
Time frame: Week 18
Preliminary tumor response
Computed Tomography (CT) scan
Time frame: Week 24
Preliminary tumor response
Computed Tomography (CT) scan
Time frame: Week 30
Preliminary tumor response
Computed Tomography (CT) scan
Time frame: Week 36
Preliminary tumor response
Computed Tomography (CT) scan
Time frame: Week 42
Preliminary tumor response
Computed Tomography (CT) scan
Time frame: Week 48
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Given on Day 1 of every 21-day cycle
Preliminary tumor response
Computed Tomography (CT) scan
Time frame: Week 54