An Open Label, Single Centre, Phase I Study of PI3K Inhibitor BAY80-6946 to Evaluate the Safety, Tolerability and Pharmacokinetics in Japanese Patients With Advanced or Refractory Solid Tumours
Inclusion Criteria:
- Cancer patients
- Japanese patients, who are at least 20 years of age
- Histological or cytological documentation of non-hematologic, malignant solid
tumours, excluding primary brain or spinal tumours, with no past or current
involvement in the central nervous system (CNS)
- At least one measurable lesion or evaluable disease according to RECIST (version 1.1)
- Eastern Cooperative Oncology performance status (ECOG-PS) of 0 or 1
- Life expectancy of at least 12 weeks
- Advanced or refractory solid tumours not amenable to standard therapy, at the first
screening examination/visit
Exclusion Criteria:
- Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of first
study treatment. Patients must have recovered from the toxic effects of the previous
anti-cancer chemotherapy or immunotherapy by the investigator (with the exception of
alopecia).
- Radiotherapy to target lesions during study or within 4 weeks of first study
treatment
- Investigational drug therapy outside of this trial during or within 4 weeks of first
study treatment
- Current diagnosis of Type I or II diabetes mellitus or fasting blood glucose level
>125 mg/dL at screening, and/or HbA1c>/= 6.5%
- Past and current histories of cardiac disease congestive heart failure > New York
Heart Association (NYHA) Class II; active coronary artery disease, myocardial
infarction within 6 months prior to study entry; new onset of angina within 3 months
prior to study entry or unstable angina or ventricular cardiac arrhythmias requiring
anti-arrhythmic therapy
- Active and clinically serious infections >Grade 2 (National Cancer Institute Common
Terminology Criteria for Adverse Events [NCI-CTCAE] version 4.03)
- Uncontrolled hypertension defined as systolic blood pressure >150 mm Hg or diastolic
pressure > 90 mm Hg, despite optimal medical management
- Patients undergoing renal dialysis
- Pregnant or breast feeding women