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: Yes
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
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Contact
Cancer Clinical Trials Office
650-498-7061
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