Phase 1 Study of Single Agent BAY86-9766 in Japanese Patients With Advanced or Refractory Solid Tumors
Inclusion Criteria:
- Japanese patients, who are at least 18 years of age at the first screening
examination/ visit, with advanced or refractory solid tumors not amenable to standard
therapy.
- Histological or cytological documentation of non-hematologic, malignant solid tumor,
excluding primary brain or spinal tumors, with no current involvement in the central
nervous system (CNS)
- At least one measurable lesion or evaluable disease according to response evaluation
criteria in solid tumors (RECIST) version 1.1
- Eastern cooperative oncology group performance status (ECOG-PS) of 0 or 1
- Life expectancy of at least 12 weeks
Exclusion Criteria:
- Use of any anti-cancer therapy including chemotherapy, investigational agents or
devices and immunotherapy within 4 weeks of the first dose of study medication
- Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic
pressure > 90 mmHg, despite optimal medical management
- Known human immunodeficiency virus (HIV) infection or chronic active hepatitis B or C
- Inadequate bone marrow, liver and renal function
- Inability to swallow oral medications or any condition that could affect the
absorption of orally administered drugs
- Concomitant treatment with cytochrome P450 isoenzymes CYP3A4 inhibitors/inducers, and
CYP2C19 inhibitors/ inducers