At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 70 enrolled
Drug / intervention
Sorafenib Tosylate +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 I/II Study of the Raf Kinase and Receptor Tyrosine Kinase Inhibitor Sorafenib (BAY 43-9006, NSC# 724772) in Children With Refractory Solid Tumors or Refractory Leukemias
In Brief
A Phase 2 clinical trial evaluating Laboratory Biomarker Analysis, Pharmacological Study, and 1 other intervention for Blastic Phase and 9 related conditions. Completed, enrolled 70 participants across 25 sites in 2 countries.
Detailed Summary
This phase I/II trial is studying the side effects and best dose of sorafenib in treating young patients with relapsed or refractory solid tumors or leukemia. Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBlastic Phase, Childhood Acute Promyelocytic Leukemia With PML-RARA, Childhood Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Childhood Solid Neoplasm, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Juvenile Myelomonocytic Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 Positive Chronic Myelogenous Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Recurrent Disease
CountriesCanada, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2006
First PostedOct 2011
Primary CompletionMar 2012
Study CompletionDec 2012
TodayJul 2026
First PostedOct 3, 2011
Enrollment StartMay 30, 2006
Primary CompletionMar 16, 2012
Study CompletionDec 10, 2012
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 14.7 years ago
Interventions
Laboratory Biomarker Analysisother
Correlative studies
Pharmacological Studyother
Correlative studies
Sorafenib Tosylatedrug
Given orally