Tumors
Conditions
Keywords
Solid Tumors
Brief summary
This study is to define the pharmacokinetics and to evaluate the safety of BAY73-4506, 160 mg once daily administered orally as a single agent in Japanese patients with advanced solid tumors.
Interventions
The patients will be treated on Day 1 of the first week followed by 6 days off treatment (Cycle 0, single dosing period). After Cycle 0, the patients will be treated with BAY 73-4506 (160 mg once daily orally, 21 days on/ 7 days off schedule). Dose level : 160 mgDose level-1: 120 mgDose level-2: 60 mg
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female Japanese patients \>/= 18 years * Histologically or cytologically confirmed solid tumors * ECOG-PS 0 - 1 * Adequate bone marrow, liver and renal function
Exclusion criteria
* Uncontrolled hypertension * Patients with severe renal impairment or on dialysis * Patients with seizure disorder requiring anticonvulsant medication * Known or suspected allergy to the investigational agent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Grade 4 neutropenia for >/= 7 days, febrile neutropenia with Grade 4 neutropenia, Grade 4 thrombocytopenia, Grade 3 or 4 non-hematologic toxicity, hypertension and skin toxicity of Grade 3 or 4 which are not manageable and pharmacokinetics | After 5 weeks (after Cycle 1). |
Secondary
| Measure | Time frame |
|---|---|
| Biomarker | At screening |
| Response rate | Every 8 weeks for the first 6 cycles. After Cycle 6, every 12 weeks |
Countries
Japan
Outcome results
None listed