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

Not Recruiting

Trial ID: NCT01455493


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

Stanford Investigator(s)

Jonathan S. Berek, MD, MMSc
Jonathan S. Berek, MD, MMSc

Laurie Kraus Lacob Professor


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

   - 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

   - 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


drug: GDC-0980

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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