Status:
COMPLETED
A Study of GDC-0980 in the Treatment of Recurrent or Persistent Endometrial Carcinoma
Lead Sponsor:
Genentech, Inc.
Conditions:
Endometrial Carcinoma
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 pharmacokin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT01455493
Start Date
December 1 2011
End Date
January 1 2014
Last Update
August 11 2016
Active Locations (28)
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1
Phoenix, Arizona, United States, 85013
2
Newport Beach, California, United States, 92663
3
Orange, California, United States, 92868
4
Palo Alto, California, United States, 94305