Status:
COMPLETED
Phase I Study to Investigate Pharmacokinetics and Safety of BAY73-4506 in Asian (Japanese) Patients With Solid Tumors.
Lead Sponsor:
Bayer
Conditions:
Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 11 2013
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00960258
Start Date
July 1 2009
End Date
November 11 2013
Last Update
September 27 2017
Active Locations (4)
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1
Kashiwa-shi, Chiba, Japan, 277-8577
2
Hidaka, Saitama, Japan, 350-1298
3
Chuo-ku, Tokyo, Japan, 104-0045
4
Mitaka, Tokyo, Japan, 181-8611