A Study of GDC-0980 in the Treatment of Recurrent or Persistent Endometrial Carcinoma

Phase 2

Completed

Brief Summary: This is a multicenter, single-arm, open-label Phase II study to evaluate the activity of GDC-0980 in patients with recurrent or persistent endometrial cancer. The safety, tolerability, and pharmacokinetics of GDC-0980 will also be evaluated.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
A	GDC-0980	-

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS), defined as the time from the first GDC-0980 treatment to disease progression as assessed by the investigator using RECIST v1.1, or death from any cause while on study	at 6 months
Objective tumor response as assessed by the investigator using RECIST v1.1	up to approximately 23 months

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events	up to approximately 23 months
Nature of adverse events	up to approximately 23 months
Overall survival (OS), defined as the time from treatment initiation until death from any cause	up to approximately 36 months
Duration of objective tumor response defined as the time from first observation of an objective tumor response until first observation of disease progression as assessed by the investigator using RECIST v1.1	up to approximately 23 months
Severity of adverse events	up to approximately 23 months