A Phase II, Open Label, Randomized Study of GDC-0980 Versus Everolimus in Patients With Metastatic Renal Cell Carcinoma Who Have Progressed on or Following VEGF-Targeted Therapy
Inclusion Criteria:
- Histologically or cytologically documented, incurable metastatic renal cell carcinoma
with clear-cell component that progressed on or within 6 months of stopping
VEGF-targeted therapy
- Disease that is measurable per RECIST v1.1
- Karnofsky performance status of >= 70%
- Adequate hematologic and end organ function
- For female patients of childbearing potential and male patients with partners of
childbearing potential, agreement to use two effective forms of contraception and to
continue its use for the duration of the study
Exclusion Criteria:
- Any anti-cancer therapy, including chemotherapy, biologic or other targeted therapy,
herbal therapy, hormonal therapy, or radiotherapy, within 5 half-lives (for systemic
agents) or 2 weeks, whichever is shorter, prior to Day 1
- Requirement for chronic antihyperglycemic therapy
- Current dyspnea at rest or any requirement for supplemental oxygen therapy to perform
activities of daily living
- Previously established diagnosis of pulmonary fibrosis of any cause
- Current unstable angina
- History of myocardial infarction within 6 months prior to Day 1
- New York Heart Association (NYHA) Class II or greater congestive heart failure
- History of malabsorption syndrome or other condition that would interfere with
enteral absorption
- Clinically significant history of liver disease, including cirrhosis and current
alcohol abuse
- Presence of positive test results for hepatitis B or hepatitis C
- Known HIV infection
- Active infection requiring IV antibiotics
- Active autoimmune or inflammatory disease that is not controlled by nonsteroidal
anti-inflammatory drugs
- Pregnancy, lactation, or breastfeeding
- Current severe, uncontrolled systemic disease
- Major surgical procedure or significant traumatic injury within 28 days prior to Day
1 or anticipation of the need for major surgery during the course of study treatment
- Uncontrolled hypercalcemia
- Uncontrolled hypomagnesemia or hypokalemia
- Leptomeningeal disease as a manifestation of cancer
- History of other malignancies = 5 years of Day 1 except for tumors with a
negligible risk for metastasis or death, such as adequately controlled basal cell
carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- Untreated or active central nervous system (CNS) metastases
- Need for current chronic corticosteroid therapy (>/= 10 mg of prednisone per day or
an equivalent dose of other anti-inflammatory corticosteroids for > 7 days) or use of
other immunosuppressants