Study of Safety and Efficacy in Patients With Malignant Rhabdoid Tumors (MRT) and Neuroblastoma
Status:
Terminated
Trial end date:
2017-06-29
Target enrollment:
Participant gender:
Summary
LEE011 is a small molecule inhibitor of CDK4/6. LEE011 has demonstrated in vitro and in vivo
activity in both tumor models. The primary purpose of this study was to determine the maximum
tolerated dose (MTD) and/or recommended dose for expansion (RDE) in pediatric patients and to
delineate a clinical dose to be used in future studies. This study was also to have assessed
the safety, tolerability, PK and preliminary evidence of antitumor activity of LEE011 in
patients with MRT or neuroblastoma.