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Extension Program for Bay 43-9006

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00657254
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : December 23, 2014
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Neoplasm Metastasis Drug: Nexavar (Sorafenib, BAY43-9006) Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Extension Program for Bay 43-9006
Study Start Date : December 2002
Primary Completion Date : June 2005
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Arm 1 Drug: Nexavar (Sorafenib, BAY43-9006)
Bay 43-9006 400mg (2 x 200mg tablets) orally twice daily until withdrawal.


Outcome Measures

Primary Outcome Measures :
  1. Survival [ Time Frame: Death ]

Secondary Outcome Measures :
  1. Objective Tumour Response Rate [ Time Frame: Number of confirmed partial and complete responses ]
  2. Overall Response Duration [ Time Frame: Time from the date of the first intake of sorafenib to the date that progressive disease is documented. ]
  3. 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. ]
  4. Time to Disease Progression [ Time Frame: Time from first intake of sorafenib to disease progression ]
  5. Safety Parameters [ Time Frame: Throughout study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00657254


Locations
United States, Massachusetts
Boston, Massachusetts, United States, 02115-6084
Belgium
Bruxelles - Brussel, Belgium, 1000
Canada, Ontario
Hamilton, Ontario, Canada, L8V 5C2
Toronto, Ontario, Canada, M5G 2M9
Germany
Essen, Nordrhein-Westfalen, Germany, 45147
Herne, Nordrhein-Westfalen, Germany, 44625
Sponsors and Collaborators
Bayer
Investigators
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
First Posted: April 14, 2008    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: December 2014

Keywords provided by Bayer:
Extension
Sorafenib
Survival

Additional relevant MeSH terms:
Sorafenib
Niacinamide
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs