A Multicenter, Single-Arm, Open-Label, Phase II Study of GDC-0980 for The Treatment of Recurrent or Persistent Endometrial Carcinoma

Inclusion Criteria:

- Patients must have recurrent or persistent endometrial carcinoma that is refractory
to curative therapy or established treatments

- Histologic confirmation of the original primary tumor is required

- Histologic or cytologic confirmation of the recurrent/progressive disease is desired

- Patients must have had at least one but no more than two prior chemotherapeutic
regimens for management of endometrial carcinoma

- Disease that is measurable per RECIST v1.1

- No active infection requiring antibiotics

- Any hormonal therapy directed at the malignant tumor must be discontinued at least 2
weeks prior to first study treatment

- Any other prior therapy directed at the malignant tumor, including immunologic agents
and radiotherapy, must be discontinued at least 2 weeks prior to first study
treatment

- Adequate hematologic and end organ function

Exclusion Criteria:

- Type I diabetes or Type II diabetes requiring insulin

- Prior use of mTOR/PI3K inhibitor

- Current dyspnea at rest or any requirement for supplemental oxygen therapy to perform
activities of daily living

- Previous diagnosis of pulmonary fibrosis of any cause

- History of myocardial infarction or unstable angina within 6 months prior to first
study treatment

- 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 autoimmune disease that is not controlled by nonsteroidal anti inflammatory
drugs

- Need for current chronic corticosteroid therapy

- 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

- Leptomeningeal disease as a manifestation of cancer

- Known untreated or active brain metastases

- Grade >=2 hypercholesterolemia or hypertriglyceridemia