At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 118 enrolled
Drug / intervention
Alisertib +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of MLN8237, a Selective Aurora A Kinase Inhibitor in Children With Recurrent/Refractory Solid Tumors and Leukemias
In Brief
A Phase 2 clinical trial evaluating Alisertib, Laboratory Biomarker Analysis, and 1 other intervention for Hepatoblastoma and 10 related conditions. Completed, enrolled 118 participants across 105 sites in 2 countries.
Detailed Summary
This phase II trial is studying the side effects of and how well alisertib works in treating young patients with relapsed or refractory solid tumors or leukemia. Alisertib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatoblastoma, Previously Treated Childhood Rhabdomyosarcoma, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Recurrent Childhood Kidney Neoplasm, Recurrent Childhood Malignant Germ Cell Tumor, Recurrent Childhood Rhabdomyosarcoma, Recurrent Childhood Soft Tissue Sarcoma, Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Recurrent Neuroblastoma, Recurrent Osteosarcoma
CountriesCanada, United States
CollaboratorsNational Cancer Institute (NCI)
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 2010
Enrollment StartFeb 2011
Primary CompletionDec 2015
Study CompletionJun 2019
TodayJul 2026
First PostedJul 1, 2010
Enrollment StartFeb 1, 2011
Primary CompletionDec 31, 2015
Study CompletionJun 30, 2019
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 16.0 years ago
Interventions
Alisertibdrug
Given orally
Laboratory Biomarker Analysisother
Correlative studies
Pharmacological Studyother
Correlative studies