SARC016: Study of Everolimus With Bevacizumab to Treat Refractory Malignant Peripheral Nerve Sheath Tumors
NCT ID: NCT01661283
Last Updated: 2019-03-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
25 participants
INTERVENTIONAL
2012-09-30
2017-12-31
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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Arm A
All patients with MPNST will continue everolimus 10 mg daily and bevacizumab 10 mg/kg dose every 14 days
everolimus
10 mg tablet once daily
bevacizumab
10 mg/kg dose every 14 days
Interventions
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everolimus
10 mg tablet once daily
bevacizumab
10 mg/kg dose every 14 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Unresectable or metastatic sporadic or NF1 associated high-grade MPNST
* Experienced progression after one or more prior regimens of cytotoxic chemotherapy
* Patients must be able to swallow tablets
* Patients must have measurable disease, defined as at least one tumor that is measurable
* Patients who develop a recurrence or progression (WHO criteria) of an MPNST in a previously radiated field may be enrolled if it has been at least 4 weeks since the last dose of radiation therapy
* Patients must have recovered from the toxic effects of all prior therapy before entering this study
* Adequate organ function
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Patents who received an anthracycline prior to enrollment must have an ejection fraction ≥ 50%
* Subjects of childbearing potential requires acceptable form of birth control
* Informed consent
Exclusion Criteria
* Patients may not be currently receiving strong inhibitors of CYP3A4, and may not have received these medications within 1 week of entry
* Prior radiotherapy within 4 weeks of the start of study drug
* Patients who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug,
* Patients who have not recovered from the side effects of any major surgery
* Patients that may require major surgery during the course of the study
* Less than 7 days have passed from core biopsies or other minor surgical procedures excluding placement of a vascular access device
* Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent(Topical or inhaled corticosteroids are allowed)
* Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
* Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
* Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
* Female patients who are pregnant or breast feeding
* Patients who have received prior treatment with an mTOR inhibitor or bevacizumab
* Patients with known hypersensitivity to rapamycins
* concurrent use of anti-coagulant drugs
* Patients using Seville orange, star fruit, grapefruit and their juices, and St. John's Wort
* Patients taking enzyme inducing anticonvulsants
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Genentech, Inc.
INDUSTRY
United States Department of Defense
FED
Sarcoma Alliance for Research through Collaboration
OTHER
Responsible Party
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Principal Investigators
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Brigitte C. Widemann, MD
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Ann and Robert Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
Johns Hopkins
Baltimore, Maryland, United States
National Cancer Institute
Bethesda, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Washington University in St. Louis
St Louis, Missouri, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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SARC Website
Other Identifiers
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SARC016
Identifier Type: -
Identifier Source: org_study_id
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