Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04106219

A Study of LY3295668 Erbumine in Participants With Relapsed/Refractory Neuroblastoma

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Neuroblastoma Brain Diseases Central Nervous System Diseases Epilepsy Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral

Age range

2 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Perth Children's Hospital, Perth, Western Australia, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LY3295668 Erbumine

Drug

Administered orally.

Topotecan

Drug

Administered IV.

Cyclophosphamide

Drug

Administered IV.

Primary outcomes

  1. Number of Participants with Dose Limiting Toxicities (DLTs)

    Time frame: Baseline through Cycle 2 (28 Day Cycle)

    Number of Participants with DLTs

  2. Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)

    Time frame: Baseline through Measured Progressive Disease (Estimated up to 5 Years)

    ORR

  3. Duration of Response (DoR)

    Time frame: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 5 Years)

    DoR

Secondary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668

    Time frame: Cycle 1 Day 1 through Cycle 1 Day 15 (28 Day Cycles)

    PK: AUC of LY3295668

  2. PK: AUC of LY3295668 in Combination with Topotecan and Cyclophosphamide

    Time frame: Cycle 1 Day 1 through Cycle 1 Day 15 (28 Day Cycles)

    PK: AUC of LY3295668 in Combination with topotecan and cyclophosphamide

  3. Best Overall Response (BOR): Percentage of Participants with CR, PR, Stable Disease (SD), or Progressive Disease (PD)

    Time frame: Baseline to Date of Objective Disease Progression (Estimated up to 5 Years)

    BOR

  4. Progression-Free Survival (PFS)

    Time frame: Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 5 Years)

    PFS

  5. Overall Survival (OS)

    Time frame: Baseline to Date of Death from Any Cause (Estimated up to 6 Years)

    OS

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Innovative Therapies for Children with Cancer in Europe (ITCC)
  • New Approaches to Neuroblastoma Therapy Consortium

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2026
First posted
Sep 26, 2019
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.