A phase II uncontrolled study of BAY 73-4506 in previously untreated patients with metastatic or unresectable renal cell cancer (RCC)

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 49

Inclusion Criteria

1. Greater than or equal to 18 years, either sex
2. Unresectable and/or metastatic clear cell renal cell cancer
3. Previously untreated disease
4. Measurable lesion(s) by computed tomography (CT) scan/magnetic resonance imaging (MRI)
5. Intermediate or low Motzer score
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
7. Adequate bone marrow, renal and hepatic function as assessed by specific laboratory tests
8. Life expectancy of at least 12 weeks
9. Signed informed consent

Exclusion Criteria

1. Previous/concurrent cancer
2. Previous systemic treatment of RCC
3. Cardiac arrhythmias requiring anti-arrythmics
4. History of cardiac disease or congestive heart failure greater than New York Heart Association (NYHA) class 2
5. Uncontrolled hypertension despite optimal medical management
6. Cardiac ventricular arrhythmias requiring anti-arrhythimics
7. Active clinically serious infections
8. History of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
9. Know history of symptomatic metastatic brain or meningeal tumours
10. Seizure disorders requiring medication
11. History of organ allograft
12. History or evidence of bleeding diathesis
13. Serious non-healing wound, ulcer or bone fracture
14. Patients undergoing renal dialysis
15. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
16. Known or suspected allergy to the investigational drug or any agent given in association with the trial
17. Any condition which is unstable or which could jeopardise the safety of the patient and his/her compliance in the study
18. Pregnant or breast-feeding patients
19. Investigational drug therapy outside of the trial within 4 weeks of study entry
20. Prior exposure to the drug
21. Radiotherapy during study or within 3 weeks of start of study drug
22. Major surgery, open biopsy or significant traumatic injury within 4 weeks of start of study
23. Autologous bone marrow transplant or stem cell rescue within 4 months of study
24. Patients unable to swallow oral medications
25. Any malabsorption condition

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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