SF1126 for Patients With Relapsed or Refractory Neuroblastoma
|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.|
|ClinicalTrials.gov Identifier: NCT02337309|
Recruitment Status : Terminated (Low patient accrual)
First Posted : January 13, 2015
Last Update Posted : August 20, 2018
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
|Condition or disease||Intervention/treatment||Phase|
|Neuroblastoma||Drug: SF1126||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of SF1126 for Patients With Relapsed or Refractory Neuroblastoma|
|Actual Study Start Date :||July 9, 2015|
|Actual Primary Completion Date :||May 22, 2018|
|Actual Study Completion Date :||May 22, 2018|
Patients will receive SF1126 IV over 90 minutes on Days 1 and 4 of each week during each cycle.
SF1126 in IV form with be given to patients on this study.
- Toxicities, based on the CTCAE criteria, will be used to measure the severity of adverse events [ Time Frame: 6 months ]Toxicity will be graded using the CTCAE criteria, version 4. The CTCAE provides descriptive terminology and a grading scale for each adverse event listed. A copy of the CTCAE can be downloaded from the CTEP home page (http://ctep.cancer.gov).
- Evaluation of response [ Time Frame: After day 1 of week 4 of cycles 2, 4, and 6 ]Response will be determined by the evaluation of CT/MRI scans and bone marrow biopsy.
- Pharmacokinetics: Parameters include AUC, clearance, Cmax, Tmax, & terminal half-life for SF1101 & SF1174. With rapid conversion of SF1126 to SF1101, only AUC, clearance, Cmax & Tmax are calculated for SF1126. [ Time Frame: Day 1, cycle 1 ]Plasma samples will be collected from patients at 9 time points on Day 1 of the first cycle.
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 ClinicalTrials.gov identifier (NCT number): NCT02337309
|United States, California|
|Children's Hospital Los Angeles|
|Los Angeles, California, United States, 90027-0700|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94143|
|United States, Colorado|
|Children Hospital of Colorado|
|Aurora, Colorado, United States, 80045|
|United States, Georgia|
|AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus|
|Atlanta, Georgia, United States, 30322|
|United States, Illinois|
|University of Chicago Comer Children's Hospital|
|Chicago, Illinois, United States, 60637|
|United States, Massachusetts|
|Childrens Hospital Boston, Dana-Farber Cancer Institute.|
|Boston, Massachusetts, United States, 02115|
|United States, Michigan|
|C.S Mott Children's Hospital|
|Ann Arbor, Michigan, United States, 48109|
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229-3039|
|United States, Texas|
|Cook Children's Healthcare System|
|Fort Worth, Texas, United States, 76104|
|United States, Washington|
|Children's Hospital and Regional Medical Center - Seattle|
|Seattle, Washington, United States, 98105|
|Principal Investigator:||Steven DuBois, MD||Dana-Farber Cancer Institute|