A Phase II Study of ABT-751, an Orally Bioavailable Tubulin Binding Agent, in Children With Relapsed or Refractory Neuroblastoma
I. Compare the time to disease progression in children with refractory or relapsed
neuroblastoma treated with ABT-751 vs historical controls.
I. Determine the objective response rate in patients with measurable disease treatment with
II. Determine whether ABT-751 improves quality of life of these patients. III. Determine the
toxicity of ABT-751. IV. Determine the pharmacokinetic profile of ABT-751 in these patients.
Patients receive oral ABT-751 once daily on days 1-7. Treatment repeats every 21 days for 52
courses in the absence of disease progression or unacceptable toxicity.
Blood is collected periodically during course 1 for pharmacokinetic studies. Quality of life
is assessed at baseline and prior to each course of treatment.
After completion of study treatment, patients are followed up for up to 5.1 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Median time to progression as assessed by Response Evaluation Criteria in Solid Tumors
Median time to progression observed on ABT-751 versus a hypothesized model of the standard (an exponential distribution with a failure rate corresponding to a median PFS of 42 days) using the methodology of Woolson.
From time to enrollment to death due to any cause, assessed up to 5.1 years
Children's Oncology Group
United States: Food and Drug Administration
|Children's Hospital of Philadelphia||Philadelphia, Pennsylvania 19104|
|Washington University School of Medicine||Saint Louis, Missouri 63110|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Cincinnati Children's Hospital Medical Center||Cincinnati, Ohio 45229-3039|
|Nationwide Children's Hospital||Columbus, Ohio 43205-2696|
|University of Alabama at Birmingham||Birmingham, Alabama 35294-3300|
|Oregon Health and Science University||Portland, Oregon 97201|
|University of Chicago Comprehensive Cancer Center||Chicago, Illinois 60637-1470|
|Columbia University Medical Center||New York, New York 10032|
|Cook Children's Medical Center||Fort Worth, Texas 76104|
|C S Mott Children's Hospital||Ann Arbor, Michigan 48109|