Trial Condition(s):

Tumors

Phase I study to investigate pharmacokinetics and safety of BAY73-4506 in Asian (Japanese) patients with solid tumors.

Bayer Identifier:

13172

ClinicalTrials.gov Identifier:

NCT00960258

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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.

Trial Summary

Enrollment Goal
15
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Mitaka, Japan, 181-8611

Status
Completed
 
Locations

Investigative Site

Chuo-ku, Japan, 104-0045

Status
Completed
 
Locations

Investigative Site

Kashiwa-shi, Japan, 277-8577

Status
Completed
 
Locations

Investigative Site

Hidaka, Japan, 350-1298

Status
Completed
 

Trial Design