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

Participants will not be paid for their participation.


  • IRB Number: 1510394933 (PHO-COG-CROOP ADVL1414)
  • Research Study Identifier: TX5858
  • Principal Investigator: James Croop, MD, PhD

Recruitment Status

Open

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