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.
Funding Source - FDA OOPD
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02337309.
Locations matching your search criteria
United States
Colorado
Aurora
Children's Hospital ColoradoStatus: Active
Name Not Available
Inhibitors of the PI3 kinase pathway have demonstrated preclinical activity in
neuroblastoma. This activity may derive in part from destabilizing Mycn protein, impeding
tumor angiogenesis, and/or other effects. 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 preclinical
studies, SF1126 results in marked concentration of LY294002 into tumors. In an adult
phase 1 trial, a maximum tolerated dose of SF1126 was not identified up to doses of 1110
mg/m2 administered intravenously twice weekly on a continuous schedule. 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. All patients will participate in mandatory pharmacokinetic testing.
Additional optional correlative studies will evaluate potential predictive markers and
potential pharmacodynamic markers, including PTEN and PIK3CA aberrations, Myc / Mycn
expression, and Myc / pS6 levels in peripheral blood mononuclear cells.
Lead OrganizationNew Approaches to Neuroblastoma Therapy (NANT)
