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