Trial Condition(s):

Neoplasms

Phase I study of BAY73-4506 in Chinese patients with advanced, refractory solid tumors

Bayer Identifier:

14996

ClinicalTrials.gov Identifier:

NCT01096030

EudraCT Number:

Not Available

Study Completed

Trial Purpose

This will be an uncontrolled, open-label, non-randomized, phase I study.
The primary objectives of this study are to define the pharmacokinetics (PK) and to evaluate the safety and tolerability of Regorafenib administered orally as a single agent in Chinese patients with advanced solid tumors. The secondary objectives are to evaluate tumor response of patients treated with Regorafenib.

Inclusion Criteria
- Male or female Chinese subjects >/- 18 years
 - Advanced, histologically or cytologically confirmed solid tumors
 - Subjects malignancies must be refractory to standard treatment or have no standard therapy available, or the subject actively refused any treatment that would be regarded standard, and/or if, in the judgment of the investigator or his/her designated associate(s), experimental treatment is clinically and ethically acceptable.
 - Eastern Cooperative Oncology Group performance status (ECOG-PS) 0–1; 
 - Adequate bone marrow, liver and renal function  
 - Life expectancy of at least 3 months
Exclusion Criteria
- Unstable/uncontrolled cardiac disease
 - History  of arterial or venous thrombotic or embolic events
 - Malabsorption condition
 - Severe renal impairment; persistent proteinuria >/= Grade 3 
 - Symptomatic metastatic brain or meningeal tumors 
 - Clinically significant bleeding >/=Grade 3 within 30 days before start of study medication.

Trial Summary

Enrollment Goal
33
Trial Dates
black-arrow
Phase
1
Could I receive a placebo?
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

National Cancer Center

Singapore, Singapore, 169610

Status
Completed
 
Locations

Queen Mary Hospital

Hong Kong, Hong Kong, China

Status
Completed
 
Locations

Prince of Wales Hospital

Shatin, Hong Kong, China

Status
Completed
 
Locations

National University Hospital

Singapore, Singapore, 119228

Status
Completed
 

Trial Design