Long-term Extension From RCC Phase II (11515)

Bayer

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Renal Cell

Treatments: Drug: Sorafenib (Nexavar, BAY43-9006)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00586495

12056

Details and patient eligibility

About

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

Enrollment: 95 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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95 participants in 1 patient group

Sorafenib (Nexavar, BAY43-9006)

Experimental group

Description:

Sorafenib 200 mg tablets (400 mg \[2 x 200 mg tablets\] twice daily \[bid\] or 400 mg once daily \[od\] or 400 mg every other day \[qod\]) administered orally

Treatment:

Drug: Sorafenib (Nexavar, BAY43-9006)