Extension Program for Bay 43-9006

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00657254

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

1.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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

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 :

Dec 1, 2002

Actual Primary Completion Date :

Jun 1, 2005

Actual Study Completion Date :

Jun 1, 2005

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.

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

Survival [Death]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	City	State	Country	Postal Code
1	Boston	Massachusetts	United States	02115-6084
2	Bruxelles - Brussel		Belgium	1000
3	Hamilton	Ontario	Canada	L8V 5C2
4	Toronto	Ontario	Canada	M5G 2M9
5	Essen	Nordrhein-Westfalen	Germany	45147
6	Herne	Nordrhein-Westfalen	Germany	44625