Adjuvant Axitinib Treatment of Renal Cancer: A Randomized Double-blind Phase 3 Study of Adjuvant Axitinib vs. Placebo in Subjects at High Risk of Recurrent RCC
Patients must be treated by nephrectomy and patients must meet all of the following
inclusion criteria to be eligible for enrollment into the trial:
1. Patients must have no evidence of macroscopic residual disease or metastatic disease.
2. Male or female, age >=18 years (age >=20 years in Japan, Korea and Taiwan).
3. Patients must be diagnosed with one of the following based on American Joint
Committee on Cancer (AJCC) TNM staging version 2010, Eastern Collaborative Oncology
Group (ECOG) performance status (PS) and Fuhrman grade:
- pT2, pN0 or pNx, M0, Fuhrman grade 3-4 (partial Fuhrman grade 3-4 is also
acceptable) and ECOG PS 0-1
- pT3, pN0 or pNx, M0, any Fuhrman grade and ECOG PS 0-1
- pT3a; Tumor > 4 cm in greatest dimension is eligible.
- pT3b or pT3c; any size of tumor is eligible.
- pT4, pN0 or pNx, M0, any Fuhrman grade and ECOG PS 0-1
- Any pT, pN1, M0, any Fuhrman grade and ECOG PS 0-1
4. Patients must have histologically confirmed preponderant, defined as >50%, clear cell
5. Patients must not have received any previous systemic (includes chemotherapeutic,
hormonal, or immunotherapeutic) treatment for RCC.
6. Patients must not have received any previous anti angiogenic treatment.
7. Patients must have adequate organ function.
1. Histologically undifferentiated carcinomas, sarcomas, collecting duct carcinoma,
lymphoma, or patients with any metastatic renal sites.
2. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events
(CTCAE) Grade 3 hemorrhage <4 weeks of date of randomization.
3. Diagnosis of any non-RCC malignancy within the 5 years from date of randomization,
except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma of the
cervix uteri that has been adequately treated with no evidence of recurrent disease
for 12 months.
4. Any of the following within the 12 months prior to study drug administration:
myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft,
symptomatic congestive heart failure, cerebrovascular accident or transient ischemic
attack and 6 months for deep vein thrombosis or pulmonary embolism.
5. Gastrointestinal abnormalities