Extension Program for Bay 43-9006

Phase 2

Completed

• Conditions: Neoplasm; Metastasis
• Interventions: Drug: Nexavar (Sorafenib, BAY43-9006)

• Registration Number: NCT00657254
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Study First Submitted: 2008-04-08
• Study First Submitted QC: 2008-04-08
• Study First Posted: 2008-04-14
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-18
• Last Update Posted: 2014-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Nexavar (Sorafenib, BAY43-9006)	-

Primary Outcome Measures

Name	Time	Method
Survival	Death

Secondary Outcome Measures

Name	Time	Method
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