BAY86-9766 Plus Gemcitabine Phase I Study in Asian
Status:
Completed
Trial end date:
2015-02-10
Target enrollment:
Participant gender:
Summary
This is an open-label, uncontrolled, Phase Ib study designed to evaluate the safety,
tolerability, and pharmacokinetics of BAY86-9766 when given as a single agent and in
combination with gemcitabine in Asian patients with advanced or refractory solid tumors.Blood
samples for PK (pharmacokinetics) analyses will be collected after a single dose of
BAY86-9766, multiple doses of BAY86-9766, and combination treatment of gemcitabine and
BAY86-9766.
Safety evaluation will include adverse events assessment, vital signs, laboratory tests,
12-lead ECG ECG (electrocardiography), cardiac function test, and ophthalmologic examination
at various time points during the study.