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Diagnosis | Neuroblastoma | Study Status | Closed to enrollment |
Phase | I |
Age | Child, Adult - (2 Year to 21 Years) | Randomisation | YES |
Line of treatment | Disease relapse or progression |
Routes of Treatment Administration | LY3295668/Erbumine taken by mouth (capsules)
Topotecan and cyclophosphamide will be given intravenously |
Last Posted Update | 2022-03-01 |
ClinicalTrials.gov # | NCT04106219 |
International Sponsor
Eli Lilly and CompanyPrincipal Investigators for Canadian Sites
The Hospital for Sick Children - Daniel MorgensternCentres
Study Description
The reason for this study is to see if the study drug LY3295668 erbumine is safe in participants with relapsed/refractory neuroblastoma, either alone or in combination with chemotherapy.
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.