Trial Condition(s):
Neoplasm, Metastasis
Extension Program for Bay 43-9006
Bayer Identifier:
10922
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Toronto, Canada, M5G 2M9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamilton, Canada, L8V 5C2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Essen, Germany, 45147 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Boston, United States, 02115-6084 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Extension Program for Bay 43-9006
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- SurvivalTimeframe: Death
Secondary Outcome
- Objective Tumour Response RateTimeframe: Number of confirmed partial and complete responses
- Overall Response DurationTimeframe: Time from the date of the first intake of sorafenib to the date that progressive disease is documented.
- Time to Objective ResponseTimeframe: Time from the date of the first intake of sorafenib to the date that objective response is first documented.
- Time to Disease ProgressionTimeframe: Time from first intake of sorafenib to disease progression
- Safety ParametersTimeframe: Throughout study
Additional Information
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