A Study of GDC-0980 in the Treatment of Recurrent or Persistent Endometrial Carcinoma
NCT ID: NCT01455493
Last Updated: 2016-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
56 participants
INTERVENTIONAL
2011-12-31
2014-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A
GDC-0980
Oral daily dose
Interventions
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GDC-0980
Oral daily dose
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Phoenix, Arizona, United States
Newport Beach, California, United States
Orange, California, United States
Palo Alto, California, United States
San Francisco, California, United States
Denver, Colorado, United States
New Haven, Connecticut, United States
Boca Raton, Florida, United States
Orlando, Florida, United States
West Palm Beach, Florida, United States
Hinsdale, Illinois, United States
Indianapolis, Indiana, United States
Louisville, Kentucky, United States
Scarborough, Maine, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Voorhees Township, New Jersey, United States
New York, New York, United States
New York, New York, United States
Durham, North Carolina, United States
Winston-Salem, North Carolina, United States
Oklahoma City, Oklahoma, United States
Abington, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Salt Lake City, Utah, United States
Seattle, Washington, United States
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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PIM4972g
Identifier Type: -
Identifier Source: org_study_id
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