A Study of GDC-0980 in the Treatment of Recurrent or Persistent Endometrial Carcinoma
Trial ID or NCT#
NCT01455493
Status
NOT RECRUITING
Purpose
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
A Multicenter, Single-Arm, Open-Label, Phase II Study of GDC-0980 for The Treatment of Recurrent or Persistent Endometrial Carcinoma
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: Female
Accepts 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
Investigator(s)
Nelson Teng
Contact us to find out if this trial is right for you.
Contact
Cancer Clinical Trials Office
650-498-7061
View on ClinicalTrials.gov
