ABOUT THIS STUDY
for Dose Escalation Phase
1. Histologically confirmed advanced RCC.
2. Up to 2 prior systemic regimens for RCC.
3. Subject must have at least 1 measurable lesion that can be accurately measured in at least 1 dimension with the longest diameter ³10 mm when measured by spiral computed CT (5-mm slice thickness contiguous) or ³20 mm when measured by conventional CT (10-mm slice thickness contiguous) (lesion must be ³ 2 times the size of the slice thickness per RECIST).
- More criteria apply
for the Expanded Cohort Phase
1. Subjects with a history of a CNS malignancy or metastatic disease to the CNS and
subjects with a known, active CNS malignancy (primary or metastatic).
2. Prior anti-vascular endothelial growth factor (anti-VEGF) therapies (with either
monoclonal antibodies and/or tyrosine kinase inhibitors [TKIs]) and/or mTOR
3. Subjects receiving known strong CYP3A4 isoenzyme inhibitors and/or inducers. Subjects
taking other CYP3A4 isoenzyme inhibitors and/or inducers not classified as strong
inhibitors or inducers are eligible, provided they have been on a stable regimen for
at least 4 weeks before screening.
- More Criteria apply
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