Summary

for people ages 2-21 (full criteria)
at San Francisco, California and other locations
study started
estimated completion

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 more than 3 treatment regimens given after frontline initial therapy.
  • Participants must not have had prior allogeneic 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

  • University of California, San Francisco not yet accepting patients
    San Francisco California 94158 United States
  • Childrens Hospital of Los Angeles not yet accepting patients
    Los Angeles California 90027 United States

Details

Status
not yet accepting 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