Overview

Phase I Study to Investigate Pharmacokinetics and Safety of BAY73-4506 in Asian (Japanese) Patients With Solid Tumors.

Status:
Completed
Trial end date:
2013-11-11
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bayer
Criteria
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.