ABOUT THIS STUDY
- Diagnosis of Locally advanced (defined as disease not amenable to curative surgery or radiation therapy) or metastatic RCC (equivalent to Stage IV RCC according to American Joint Committee on Cancer staging) renal cell carcinoma;
- Histologic confirmed clear cell renal cell carcinoma;
- No prior systemic therapy (interleukin-2, interferon-α, chemotherapy, bevacizumab, sunitinib, sorafenib, pazopanib, axitinib, everolimus or temsirolimus) for advanced or metastatic RCC;
- Measurable disease by RECIST;
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2;
- Adequate organ system functions;
- Patients must understand and be willing to sign the written informed consent form of this study.
- Non-clear cell renal cell carcinoma
- Pregnant or lactating female.
- History of another malignancy. Note: Subjects who have had another malignancy and have
been disease-free for 3 years, or subjects with a history of completely resected
non-melanoma skin carcinoma or successfully treated in situ carcinoma are eligible.
- History or clinical evidence of central nervous system (CNS) metastases. Note:
Subjects who have previously-treated CNS metastases (surgery ± radiotherapy,
radiosurgery) and meet all 3 of the following criteria are eligible:
1. Are asymptomatic
2. No evidence of active CNS metastases for ≥3 months prior to enrolment
3. Have no requirement for steroids or anticonvulsants
- Clinically significant gastrointestinal abnormalities including, but not limited to:
1. Malabsorption syndrome
2. Major resection of the stomach or small bowel that could affect the absorption of
3. Active peptic ulcer disease
4. Inflammatory bowel disease
5. Ulcerative colitis, or other gastrointestinal conditions with increased risk of
6. History of abdominal fistula, gastrointestinal perforation, or intraabdominal
abscess within 28 days prior to beginning study treatment.
- History of any one or more of the following cardiovascular conditions within the past
1. Cardiac angioplasty or stenting
2. Myocardial infarction
3. Unstable angina
4. Symptomatic peripheral vascular disease
5. Class III or IV congestive heart failure, as defined by the New York Heart
6. History of cerebrovascular accident including transient ischemic attack (TIA).
7. Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥150
millimeters of mercury (mmHg) or diastolic blood pressure (DBP) of ≥ 90 mmHg
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