Extension Program for Bay 43-9006

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: April 8, 2008
Last updated: December 18, 2014
Last verified: December 2014
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.

Condition Intervention Phase
Drug: Nexavar (Sorafenib, BAY43-9006)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Extension Program for Bay 43-9006

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Survival [ Time Frame: Death ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective Tumour Response Rate [ Time Frame: Number of confirmed partial and complete responses ] [ Designated as safety issue: No ]
  • Overall Response Duration [ Time Frame: Time from the date of the first intake of sorafenib to the date that progressive disease is documented. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Time to Disease Progression [ Time Frame: Time from first intake of sorafenib to disease progression ] [ Designated as safety issue: No ]
  • Safety Parameters [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Enrollment: 9
Study Start Date: December 2002
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Nexavar (Sorafenib, BAY43-9006)
Bay 43-9006 400mg (2 x 200mg tablets) orally twice daily until withdrawal.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00657254

United States, Massachusetts
Boston, Massachusetts, United States, 02115-6084
Bruxelles - Brussel, Belgium, 1000
Canada, Ontario
Hamilton, Ontario, Canada, L8V 5C2
Toronto, Ontario, Canada, M5G 2M9
Essen, Nordrhein-Westfalen, Germany, 45147
Herne, Nordrhein-Westfalen, Germany, 44625
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00657254     History of Changes
Other Study ID Numbers: 10922 
Study First Received: April 8, 2008
Last Updated: December 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:

Additional relevant MeSH terms:
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on May 26, 2016