The reason for this study is to see if the study drug LY3295668 erbumine is safe in participants with relapsed/refractory neuroblastoma.
Eligibility
Sex
ALL
Min age
2 Years
Max age
21 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Number of Participants with Dose Limiting Toxicities (DLTs) — Baseline through Cycle 2 (28 Day Cycle) Number of Participants with DLTs
Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) — Baseline through Measured Progressive Disease (Estimated up to 5 Years) ORR
Duration of Response (DoR) — Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 5 Years) DoR
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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