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

Study Overview
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Brief Summary
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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.

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

Conditions
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Endometrial Carcinoma

Intervention / Treatment
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* Drug: GDC-0980


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: GDC-0980<br>* Oral daily dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective tumor response as assessed by the investigator using RECIST v1.1 |  | up to approximately 23 months | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Incidence of adverse events |  | up to approximately 23 months | 
| Nature of adverse events |  | up to approximately 23 months | 
| Severity of adverse events |  | up to approximately 23 months |