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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Page 1 of 1 (4 locations)

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