Metastasis, Neoplasm
Conditions
Keywords
Extension, Sorafenib, Survival
Brief summary
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.
Interventions
Bay 43-9006 400mg (2 x 200mg tablets) orally twice daily until withdrawal.
Sponsors
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival | Death |
Secondary
| Measure | Time frame |
|---|---|
| Objective Tumour Response Rate | Number of confirmed partial and complete responses |
| Overall Response Duration | Time from the date of the first intake of sorafenib to the date that progressive disease is documented. |
| Time to Objective Response | Time from the date of the first intake of sorafenib to the date that objective response is first documented. |
| Time to Disease Progression | Time from first intake of sorafenib to disease progression |
| Safety Parameters | Throughout study |
Countries
Belgium, Canada, Germany, United States
Outcome results
None listed