Extension Program for Bay 43-9006

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00657254
First received: April 8, 2008
Last updated: October 9, 2013
Last verified: October 2013
  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.


Condition Intervention Phase
Neoplasm
Metastasis
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: 400
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00657254     History of Changes
Other Study ID Numbers: 10922
Study First Received: April 8, 2008
Last Updated: October 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Extension
Sorafenib
Survival

Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 14, 2014