Trial Condition(s):

Neoplasm, Metastasis

Extension Program for Bay 43-9006

Bayer Identifier:

10922

ClinicalTrials.gov Identifier:

NCT00657254

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The study was designed to allow for the continuation of treatment with Sorafenib as a single agent to those patients who participated in a previous Sorafenib study that had reached its designated end-date and who were, in the opinion of the Investigator and the Sponsor, still benefiting from treatment.

Inclusion Criteria
- Patients who had participated in a previous sorafenib study  that had completed, who did not meet withdrawal criteria of the previous study and who were, in the opinion of the investigator and sponsor  still benefiting from treatment.
Exclusion Criteria
- The current cardiovascular situation of the patient was carefully re-evaluated by both the investigator and the sponsor and an informed decision as to inclusion was then  made.- Substance abuse, medical, psychological or social conditions that may have interfered with the patient's participation in the study or evaluation of the study results.- Known or suspected allergy to the investigational agent.- Any condition that was unstable or which could jeopardise the safety of the patient and his/her compliance in the study.

Trial Summary

Enrollment Goal
9
Trial Dates
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Phase
2
Could I receive a placebo?
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Toronto, Canada, M5G 2M9

Status
Completed
 
Locations

Investigative Site

BRUXELLES - BRUSSEL, Belgium, 1000

Status
Completed
 
Locations

Investigative Site

Hamilton, Canada, L8V 5C2

Status
Completed
 
Locations

Investigative Site

Essen, Germany, 45147

Status
Completed
 
Locations

Investigative Site

Boston, United States, 02115-6084

Status
Completed
 

Trial Design