A Phase 1 Study of Selinexor (KPT-330 IND#125052) a Selective XPO1 Inhibitor in Recurrent and Refractory Pediatric Solid Tumors Including CNS Tumors.

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Updated on 19 February 2024

Summary

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.

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.

Participants will not be paid for their participation.

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Participants will not be paid for their participation.

Details
Condition Cancer,Solid Tumor
Age 1years - 21years
Clinical Study IdentifierTX5858
Last Modified on19 February 2024

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