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

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: Female

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 pharmacokinetics of GDC-0980 will also be evaluated.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.

Criteria

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