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Principal Investigator: Brigitte Widemann, MD

SARC016. Phase 2 study of the mTOR inhibitor RAD001 ( everolimus ) in combination with bevacizumab ( avastin ) in patients with sporadic and neurofibromatosis type 1 (NF1) related refractory malignant peripheral nerve sheath tumors. Principal Investigator: Brigitte Widemann, MD

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Principal Investigator: Brigitte Widemann, MD

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  1. SARC016 Phase 2 study of the mTOR inhibitor RAD001 (everolimus) in combination with bevacizumab (avastin) in patients with sporadic and neurofibromatosis type 1 (NF1) related refractory malignant peripheral nerve sheath tumors Principal Investigator: Brigitte Widemann, MD National Cancer Institute, National Institutes of Health

  2. SARC016 • SARC • Sponsor and coordinating center • DoD • Grant supporting clinical trial • Novartis • Providing everolimus • Genetech • Providing bevacizumab

  3. SARC016 • Background • NF1 activation results in aberrant activation mTOR • Sirolimus halts tumor growth and prolongs survival in a genetically engineered NF1 mouse model of MPNST • VEGF expression is increased in MPNST and correlates with poor outcome

  4. SARC016 Patients with NF1 related or sporadic refractory MPNST N=25 patients • Primary objectives: • Clinical benefit rate (CR, PR, SD at ≥ 4 months, WHO) • Toxicity and safety of RAD001 and bevacizumab 28 day cycles of everolimus (daily dosing) + bevacizumab (day 1 and 14) • 2 stage design: • If > 1 of 15 pt respond accrual will continue to a total of 25 patients Ongoing tumor assessment imaging every 2 cycles until disease progression or unacceptable toxicity for a maximum of 2 years

  5. SARC016 Participation • Sites open to enrollment • National Cancer Institute • Pennsylvania Oncology • Lurie Children’s Hospital of Chicago • University of Michigan • Washington University, St. Louis • Children’s National Medical Center • Johns Hopkins • University of Iowa • Cincinnati Children’s Hospital • Massachusetts General Hospital and Dana Farber • Sites pending • University of Alabama at Birmingham • Children’s Hospital of Philadelphia

  6. Study Status • Current Enrollment • n= 9 • On study treatment • n= 2 • Off study • n= 7

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