Study Completed

Neoplasm, Metastasis

Bayer Identifier:

10922

ClinicalTrials.gov Identifier:

NCT00657254

EudraCT Number:

Not Available

EU CT Number:

Not Available

Extension Program for Bay 43-9006

Trial 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.

Key Participants Requirements

Sex

Both

Age

18 Years

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.

Trial summary

Enrollment Goal

Trial Dates

December 2002 - June 2005

Phase

Phase 2

Could I Receive a placebo

Products

Nexavar (Sorafenib, BAY43-9006)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Toronto, M5G 2M9, Canada
Withdrawn		Herne, 44625, Germany
Completed		BRUXELLES - BRUSSEL, 1000, Belgium
Completed		Hamilton, L8V 5C2, Canada
Completed		Essen, 45147, Germany
Completed		Boston, 02115-6084, United States

Primary Outcome

Survival
Time Frame:
Death
Safety Issue:
no

Secondary Outcome

Objective Tumour Response Rate
Time Frame:
Number of confirmed partial and complete responses
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.
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.
Safety Issue:
no
Time to Disease Progression
Time Frame:
Time from first intake of sorafenib to disease progression
Safety Issue:
no
Safety Parameters
Time Frame:
Throughout study
Safety Issue:
yes

Trial design

Extension Program for Bay 43-9006

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Non-randomized

Blinding

Open Label

Assignment

Single Group Assignment

Trial Arms

Additional Information

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