Back to resultsExtension Program for Bay 43-9006
Primary Purpose
Neoplasm, Metastasis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Nexavar (Sorafenib, BAY43-9006)
Sponsored by
About this trial
This is an interventional treatment trial for Neoplasm focused on measuring Extension, Sorafenib, Survival
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
Outcomes
Primary Outcome Measures
Survival
Secondary Outcome Measures
Objective Tumour Response Rate
Overall Response Duration
Time to Objective Response
Time to Disease Progression
Safety Parameters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00657254
Brief Title
Extension Program for Bay 43-9006
Official Title
Extension Program for Bay 43-9006
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm, Metastasis
Keywords
Extension, Sorafenib, Survival
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Nexavar (Sorafenib, BAY43-9006)
Intervention Description
Bay 43-9006 400mg (2 x 200mg tablets) orally twice daily until withdrawal.
Primary Outcome Measure Information:
Title
Survival
Time Frame
Death
Secondary Outcome Measure Information:
Title
Objective Tumour Response Rate
Time Frame
Number of confirmed partial and complete responses
Title
Overall Response Duration
Time Frame
Time from the date of the first intake of sorafenib to the date that progressive disease is documented.
Title
Time to Objective Response
Time Frame
Time from the date of the first intake of sorafenib to the date that objective response is first documented.
Title
Time to Disease Progression
Time Frame
Time from first intake of sorafenib to disease progression
Title
Safety Parameters
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115-6084
Country
United States
City
Bruxelles - Brussel
ZIP/Postal Code
1000
Country
Belgium
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45147
Country
Germany
City
Herne
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44625
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Extension Program for Bay 43-9006
We'll reach out to this number within 24 hrs