Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Genentech, Inc.

Intervention(s):

  • Drug: GDC-0980

Phase:

Phase 2

Eligibility


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

18 Years - N/A

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting