Know Cancer

forgot password

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

Phase 2
18 Years
Open (Enrolling)
Renal Cell Carcinoma

Thank you

Trial Information

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 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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS), defined as the time from randomization to disease progression, as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, or death from any cause on study

Outcome Time Frame:

Up to 23 months

Safety Issue:


Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

October 2011

Completion Date:

January 2015

Related Keywords:

  • Renal Cell Carcinoma
  • Carcinoma
  • Carcinoma, Renal Cell



Miami, Florida  33176
Albany, New York  12208
Cleveland, Ohio  44195
Nashville, Tennessee  37203-1632
Boston, Massachusetts  
Charlotte, North Carolina  
Las Vegas, Nevada  89109