SARC016: Study of Everolimus With Bevacizumab to Treat Refractory Malignant Peripheral Nerve Sheath Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01661283
Recruitment Status : Unknown
Verified October 2016 by Sarcoma Alliance for Research through Collaboration.
Recruitment status was:  Active, not recruiting
First Posted : August 9, 2012
Last Update Posted : October 13, 2016
Novartis Pharmaceuticals
Genentech, Inc.
United States Department of Defense
Information provided by (Responsible Party):
Sarcoma Alliance for Research through Collaboration

Brief Summary:
To determine the clinical response rate of everolimus in combination with bevacizumab for patients with chemotherapy refractory sporadic or neurofibromatosis type 1 (NF1) associated malignant peripheral nerve sheath tumor (MPNST). To evaluate the toxicity and safety of everolimus in combination with bevacizumab in individuals with MPNST

Condition or disease Intervention/treatment Phase
Malignant Peripheral Nerve Sheath Tumors MPNST Sarcoma Drug: everolimus Drug: bevacizumab Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of the mTOR Inhibitor Everolimus in Combination With Bevacizumab in Patients With Sporadic and Neurofibromatosis Type 1 (NF1) Related Refractory Malignant Peripheral Nerve Sheath Tumors
Study Start Date : September 2012
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
Experimental: Arm A
All patients with MPNST will continue everolimus 10 mg daily and bevacizumab 10 mg/kg dose every 14 days
Drug: everolimus
10 mg tablet once daily
Other Name: Afinitor, everolimus

Drug: bevacizumab
10 mg/kg dose every 14 days
Other Name: Avastin

Primary Outcome Measures :
  1. Evaluation of lesions for progression or response via Who criteria [ Time Frame: great than or equal to 4 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients 18 or older
  • 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
  • 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 currently receiving anticancer therapies or who have received anticancer therapies within 3 weeks of the start of study drug or patients receiving prior treatment with investigational drugs 4 weeks of the start of study drug
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01661283

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-0024
United States, District of Columbia
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
United States, Illinois
Ann and Robert Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Maryland
Johns Hopkins
Baltimore, Maryland, United States, 21218
National Cancer Institute
Bethesda, Maryland, United States, 20892-1101
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Missouri
Washington University in St. Louis
St. Louis, Missouri, United States, 63130
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, United States, 19106
Sponsors and Collaborators
Sarcoma Alliance for Research through Collaboration
Novartis Pharmaceuticals
Genentech, Inc.
United States Department of Defense
Principal Investigator: Brigitte C. Widemann, MD National Cancer Institute (NCI)

Additional Information:
Responsible Party: Sarcoma Alliance for Research through Collaboration Identifier: NCT01661283     History of Changes
Other Study ID Numbers: SARC016
First Posted: August 9, 2012    Key Record Dates
Last Update Posted: October 13, 2016
Last Verified: October 2016

Keywords provided by Sarcoma Alliance for Research through Collaboration:
malignant peripheral nerve sheath tumors
mTOR inhibitor

Additional relevant MeSH terms:
Nerve Sheath Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Peripheral Nervous System Neoplasms
Nervous System Neoplasms
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents