A Phase I, Multi-center, Open-label Study of LEE011 in Patients With Malignant Rhabdoid Tumors and Neuroblastoma
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence rate of dose limiting toxicities (DLTs)
Estimate the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) of LEE011 as a single agent when administered orally to patients with malignant rhabdoid tumors (MRTs) or neuroblastoma
cycle 1 = 28 days (from the time of first dose)
Yes
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
United States: Food and Drug Administration
CLEE011X2102
NCT01747876
May 2013
November 2014
Name | Location |
---|---|
University of California San Francisco Dept of Pediatic Oncology | San Francisco, California 94101 |
Children's Healthcare of Atlanta Dept of Oncology | Atlanta, Georgia 30342 |
Dana Farber Cancer Institute SC-7 | Boston, Massachusetts 02115 |
Seattle Cancer Care Alliance/Fred Hutchinson Cancer Research Dept Oncology | Seattle, Washington 98109-1023 |
Cincinnati Children's Hospital Medical Center Dept of Oncology | Cincinnati, Ohio 45229-3039 |
St. Jude's Children's Research Hospital Dept of Oncology | Memphis, Tennessee 38105-2794 |
Memorial Sloan Kettering Cancer Center Dept of Onc | New York, New York 10021 |
Children's Hospital of Philadelphia Dept of Oncology | Philadelphia, Pennsylvania 19104-4399 |