The primary purpose of program was to enable patients, currently receiving sorafenib
(Nexavar) in a Bayer/Onyx sponsored clinical trial, to continue sorafenib treatment after
their respective study had met its primary endpoint and/or had reached the end as defined in
the original protocol. Patients were able to continue treatment until (i) the treating
physician felt the patient was no longer benefiting from the treatment or (ii) the treatment
becomes commercially available and reimbursed for the respective indication as applicable in
the country in which the patient lived and the patient could obtain suitable amounts of drug
for treatment through standard mechanisms of commercial availability (ie, there should be no
interruption in the patient's treatment schedule when switching to commercially available
product) or (iii) the patient could join a Post-Trial-Access Program, another study or can
receive sorafenib through any other mechanism (e.g. local access program) in accordance with
local legal and compliance rules, with no cost to the patient with respect to sorafenib.
An additional objective was the assessment of the safety of Nexavar or Nexavar combination
treatment.