check_circleStudy Completed
Neoplasm, Metastasis
Bayer Identifier:
10922
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Extension Program for Bay 43-9006
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.
Key Participants Requirements
Sex
BothAge
18 YearsTrial summary
Enrollment Goal
9Trial Dates
December 2002 - June 2005Phase
Phase 2Could I Receive a placebo
NoProducts
Nexavar (Sorafenib, BAY43-9006)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Toronto, M5G 2M9, Canada | |
Withdrawn | Herne, 44625, Germany | |
Completed | BRUXELLES - BRUSSEL, 1000, Belgium | |
Completed | Hamilton, L8V 5C2, Canada | |
Completed | Essen, 45147, Germany | |
Completed | Boston, 02115-6084, United States |
Primary Outcome
- Survivaldate_rangeTime Frame:Deathenhanced_encryptionnoSafety Issue:
Secondary Outcome
- Objective Tumour Response Ratedate_rangeTime Frame:Number of confirmed partial and complete responsesenhanced_encryptionnoSafety Issue:
- Overall Response Durationdate_rangeTime Frame:Time from the date of the first intake of sorafenib to the date that progressive disease is documented.enhanced_encryptionnoSafety Issue:
- Time to Objective Responsedate_rangeTime Frame:Time from the date of the first intake of sorafenib to the date that objective response is first documented.enhanced_encryptionnoSafety Issue:
- Time to Disease Progressiondate_rangeTime Frame:Time from first intake of sorafenib to disease progressionenhanced_encryptionnoSafety Issue:
- Safety Parametersdate_rangeTime Frame:Throughout studyenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1