Overview

Long-term Extension From RCC Phase II (11515)

Status:
Completed

Trial end date:
2008-07-01

Target enrollment:
0

Participant gender:
All

Summary

Extension to study 11515 (NCT00661375) which was a multicenter study of sorafenib in patients with renal cell carcinoma (RCC).

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Bayer

Treatments:

Niacinamide
Sorafenib

Criteria

Inclusion Criteria:

Patients are classified into two groups as below at transition date from Study 11515 to
this study.

Population I: Patients who are willing to continue the study drug, for whom the
investigator consider continuation of the study drug is appropriate, and who do not meet
the criteria of removal from the study in Study 11515 at the end of Study 11515.

Population II: Patients who have been monitored only for survival status at the end of
Study 11515.

Population 1

1. Patients who are willing to continue the study drug,

2. Patients for whom the investigator consider continuation of the study drug is
appropriate

3. Patients who do not meet the criteria of removal from the study in Study 11515 at the
end of Study 11515.

4. Patients who give written informed consent prior to any study specific screening
procedures with the understanding that the patient has the right to withdraw from the
study at any time, without prejudice.

Population 2

1. Patients who give written informed consent prior to any study specific screening
procedures with the understanding that the patient has the right to withdraw from the study
at any time, without prejudice.

Exclusion Criteria:

1. Substance abuse, medical, psychological or social conditions that may interfere with
the patient's participation in the study or evaluation of the study results

2. Any condition that could jeopardize the safety of the patient or that affect his/her
compliance in the study

3. Pregnant or breast-feeding patients. Both men and women enrolled in this trial must
use adequate birth control.