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Brief Title SF1126 for Patients With Relapsed or Refractory Neuroblastoma
Official Title Phase I Study of SF1126 for Patients With Relapsed or Refractory Neuroblastoma
Principal Investigator Cohn, Susan
Brief Summary SF1126 is a novel inhibitor of PI3 kinase and mTOR that includes an active moiety (consisting of LY294002) linked to an RGDS tetrapeptide that targets the active agent to integrin expressing tissues. In this first pediatric phase 1 trial of SF1126, dose escalation will follow a 3+3 dose escalation design. Once a recommended phase 2 pediatric dose is identified, an expansion cohort of 10 patients with tumors with MYCN amplification, Mycn expression, or Myc expression will be treated.
Gender Both
Ages 1 Year
Enrollment 28
Accepts Healthy Volunteers No
Lead Sponsor New Approaches to Neuroblastoma Therapy ConsortiumOther
Collaborator SignalRX Pharmaceuticals, Inc.Industry
Study Design Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Phase Phase 1
Study Type Interventional
Contact Name
Contact Phone 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials)
Condition Neuroblastoma
Detail for Health Professional (on clinicaltrials.gov)
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