Spots Global Cancer Trial Database for SF1126 for Patients With Relapsed or Refractory Neuroblastoma
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Trial Identification
Brief Title: SF1126 for Patients With Relapsed or Refractory Neuroblastoma
Official Title: Phase I Study of SF1126 for Patients With Relapsed or Refractory Neuroblastoma
Study ID: NCT02337309
Conditions
Interventions
Study Description
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. Funding Source - FDA OOPD
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Children's Hospital Los Angeles, Los Angeles, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
Children Hospital of Colorado, Aurora, Colorado, United States
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus, Atlanta, Georgia, United States
University of Chicago Comer Children's Hospital, Chicago, Illinois, United States
Childrens Hospital Boston, Dana-Farber Cancer Institute., Boston, Massachusetts, United States
C.S Mott Children's Hospital, Ann Arbor, Michigan, United States
University of North Carolina, Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Cook Children's Healthcare System, Fort Worth, Texas, United States
Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington, United States
Contact Details
Name: Steven DuBois, MD
Affiliation: Dana-Farber Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
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