A Study of LY3295668 Erbumine 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

Summary:

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

Trial Description

Primary Outcome:

• Number of Participants with Dose Limiting Toxicities (DLTs)
• Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
• Duration of Response (DoR)

• Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668
• PK: AUC of LY3295668 in Combination with Topotecan and Cyclophosphamide
• Best Overall Response (BOR): Percentage of Participants with CR, PR, Stable Disease (SD), or Progressive Disease (PD)
• Progression-Free Survival (PFS)
• Overall Survival (OS)

View this trial on ClinicalTrials.gov