Summary

Eligibility
for people ages 2-21 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Kieuhoa Vo
Photo of Kieuhoa Vo
Kieuhoa Vo

Description

Summary

The reason for this study is to see if the study drug LY3295668 erbumine is safe in participants with relapsed/refractory neuroblastoma.

Official Title

A Phase 1 Study of Aurora Kinase A Inhibitor LY3295668 Erbumine as a Single Agent and in Combination in Patients With Relapsed/Refractory Neuroblastoma

Keywords

Neuroblastoma aurora kinase A kinase aurora A aurora kinase inhibitor aurora kinase A inhibitor kinase inhibitor AURKA AurA pediatric neuroblastoma children Cyclophosphamide Topotecan LY3295668 Erbumine LY3295668 Erbumine Escalation LY3295668 Erbumine + Topotecan + Cyclophosphamide Escalation LY3295668 Erbumine Expansion LY3295668 Erbumine + Topotecan + Cyclophosphamide Expansion

Eligibility

You can join if…

Open to people ages 2-21

  • Participants must have relapsed/refractory neuroblastoma and have active disease in at least one site: bone, bone marrow or soft tissue. Participants must be able to submit an archival sample of tissue.
  • Participants must be able to swallow capsules.

You CAN'T join if...

  • Participants must not have had an allogeneic hematopoietic stem cell, bone marrow, or solid organ transplant.
  • Participants must not have untreated tumor that has spread to the brain or spinal cord.
  • Participants must not have a serious active disease other than neuroblastoma.
  • Participants must not have a condition affecting absorption.
  • Participants must not have had prior aurora kinase inhibitor exposure.
  • Participants must not have a known allergy to the study treatment.
  • Participants must not have symptomatic human immunodeficiency virus (HIV) infection or symptomatic activated/reactivated hepatitis A, B, or C.

Locations

  • UCSF Medical Center at Mission Bay accepting new patients
    San Francisco California 94158 United States
  • Childrens Hospital of Los Angeles accepting new patients
    Los Angeles California 90027 United States
  • New Approaches to Neuroblastoma Therapy (NANT) accepting new patients
    Los Angeles California 90027 United States

Lead Scientist at UCSF

  • Kieuhoa Vo
    Assistant Professor, Pediatrics. Authored (or co-authored) 17 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
Links
A Study of LY3295668 Erbumine in Participants With Relapsed/Refractory Neuroblastoma
ID
NCT04106219
Phase
Phase 1
Study Type
Interventional
Last Updated