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A Phase 1 Study of Selinexor (KPT-330 IND#125052) a Selective XPO1 Inhibitor in Recurrent and Refractory Pediatric Solid Tumors Including CNS Tumors.
Study Overview
The investigators will conduct a phase 1 trial of Selinexor in children with recurrent or refractory solid tumors, including CNS tumors using the Rolling Six design. The aims of the trial will be to establish the maximum tolerated pediatric doses of tablet formulation; to investigate the toxicities, pharmacokinetics, and pharmacodynamics of Selinexor in children with cancer; and to preliminarily explore efficacy in pediatric solid and CNS tumors, including medical and surgical expansion cohorts of HGG patients.
Study Description
The investigators will conduct a phase 1 trial of Selinexor in children with recurrent or refractory solid tumors, including CNS tumors using the Rolling Six design. The aims of the trial will be to establish the maximum tolerated pediatric doses of tablet formulation; to investigate the toxicities, pharmacokinetics, and pharmacodynamics of Selinexor in children with cancer; and to preliminarily explore efficacy in pediatric solid and CNS tumors, including medical and surgical expansion cohorts of HGG patients.
Additional Information
- IRB Number: 1510394933 (PHO-COG-CROOP ADVL1414)
- Research Study Identifier: TX5858
- Principal Investigator: James Croop, MD, PhD
Recruitment Status
OpenContact the research team to learn more about this study.
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