Clinical trial · Interventional
A Study of LY3295668 Erbumine in Participants With Relapsed/Refractory Neuroblastoma
A Phase 1 Study of Aurora Kinase A Inhibitor LY3295668 Erbumine as a Single Agent and in Combination in Patients With Relapsed/Refractory Neuroblastoma
NCT04106219CI-TRIAL-00123346active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The reason for this study is to see if the study drug LY3295668 erbumine is safe in participants with relapsed/refractory neuroblastoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| LY3295668 Erbumine | Drug | Aurora A Kinase Inhibitor LY3295668 Erbumine | ALIAS |
| Topotecan | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- LY3295668 Erbumine Escalation
- description
- LY3295668 Erbumine given orally.
- interventionNames
- Drug: LY3295668 Erbumine
- type
- EXPERIMENTAL
- label
- LY3295668 Erbumine + Topotecan + Cyclophosphamide Escalation
- description
- LY3295668 Erbumine given orally and topotecan and cyclophosphamide given intravenously (IV).
- interventionNames
- Drug: LY3295668 Erbumine
- Drug: Topotecan
- Drug: Cyclophosphamide
- type
- EXPERIMENTAL
- label
- LY3295668 Erbumine Expansion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 21 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.