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Extension Program for Bay 43-9006


Phase 2
18 Years
N/A
Not Enrolling
Both
Neoplasm, Metastasis

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Trial Information

Extension Program for Bay 43-9006


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Survival

Outcome Time Frame:

Death

Safety Issue:

No

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

United States: Food and Drug Administration

Study ID:

10922

NCT ID:

NCT00657254

Start Date:

December 2002

Completion Date:

June 2005

Related Keywords:

  • Neoplasm
  • Metastasis
  • Extension
  • Sorafenib
  • Survival
  • Neoplasms
  • Neoplasm Metastasis

Name

Location

Boston, Massachusetts