Endometrial Carcinoma
Conditions
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.
Interventions
DRUGGDC-0980
Oral daily dose
Sponsors
Genentech, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Incidence 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 |
| Severity of adverse events | up to approximately 23 months |
| Nature of adverse events | up to approximately 23 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 |
Countries
United States
Outcome results
None listed