Extension Program for Bay 43-9006

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.

Study Overview

• Status: Completed
• Conditions: Metastasis; Neoplasm
• Intervention / Treatment: Drug: Nexavar (Sorafenib, BAY43-9006)

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles - Brussel, Belgium, 1000
• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
    • Toronto, Ontario, Canada, M5G 2M9
• Germany
  • Nordrhein-Westfalen
    • Essen, Nordrhein-Westfalen, Germany, 45147
    • Herne, Nordrhein-Westfalen, Germany, 44625
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115-6084

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Survival	Death

Secondary Outcome Measures

Outcome Measure	Time Frame
Objective Tumour Response Rate	Number of confirmed partial and complete responses
Overall Response Duration	Time from the date of the first intake of sorafenib to the date that progressive disease is documented.
Time to Objective Response	Time from the date of the first intake of sorafenib to the date that objective response is first documented.
Time to Disease Progression	Time from first intake of sorafenib to disease progression
Safety Parameters	Throughout study

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: December 1, 2002
• Primary Completion (Actual): June 1, 2005
• Study Completion (Actual): June 1, 2005

Study Registration Dates

• First Submitted: April 8, 2008
• First Submitted That Met QC Criteria: April 8, 2008
• First Posted (Estimate): April 14, 2008

Study Record Updates

• Last Update Posted (Estimate): December 23, 2014
• Last Update Submitted That Met QC Criteria: December 18, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Survival; Sorafenib; Extension
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Sorafenib
• Other Study ID Numbers: 10922