Solid Tumor Treatment with Selinexor – Phase I

ADVL1414: Study of Selinexor (KPT-330), a Selective XPO1 Inhibitor, in Recurrent and Refractory Pediatric Solid Tumors Including CNS Tumors

Protocol Description

Through this Children’s Oncology Group (COG) study, researchers are evaluating the drug selinexor when used to fight recurrent tumors and tumors that will not respond to standard therapy. Selinexor has shown potential in laboratory tests and has been used in adults. As a Phase I cancer trial, this program evaluates the effects of the drug on tumors, as well as its side effects and how it is processed by the body. Researchers also evaluate the highest tolerable dosage level. This study is an initiative of COG’s Pediatric Early Phase Clinical Trial Network of which UPMC Children’s Hospital of Pittsburgh is a part.

Study Level: Phase I

Eligibility Criteria

This study has three parts and is enrolling participants, ages 12 months to 21 years. Subject to certain exclusion criteria, Part A enrolls patients who have been diagnosed with recurrent or refractory solid tumors, including lymphoma and tumors of the central nervous system. Parts B and C enroll patients with recurrent or refractory high grade Glioma.
Males and Females: Ages 12 months to 21 years

Requirements

In 4-week cycles, participants will take the study drug orally, 2 times a week for up to 24 cycles unless serious side effects occur or the participant’s tumor worsens. While taking the study drug, participants will need to visit the clinic for blood draws and examinations.
Visits: 11 in the first cycle and 5 in each subsequent cycle
Duration: Up to 2 Years

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (ADVL1414)
National Cancer Institute

Primary Investigator

Jean Tersak, MD

Contact Information

For more information about the study or enrollment, please contact:
Andrew Bukowinski, MD
412-692-5055