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Clinical Trials in Japan / NCT04106219
Active, not recruiting Phase 1

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

NCT04106219 · tracked via the Priya Life Science Japan tracker
Sponsor
Eli Lilly and Company
Phase
Phase 1
Started
2020-06-11
Last updated
2026-08-21

Condition(s) studied

Neuroblastoma

Investigational drug(s) / intervention(s)

LY3295668 ErbumineTopotecan →Cyclophosphamide →

LY3295668 Erbumine: Administered orally.

Topotecan: Administered IV.

Cyclophosphamide: Administered IV.

Study summary

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

Trial sites (17)

FacilityCityRegionStatus
UCSF Medical Center at Mission Bay San Francisco California
Children's Hospital Colorado Aurora Colorado
University of Chicago - Comer Children's Hospital Chicago Illinois
Dana-Farber Cancer Institute Boston Massachusetts
Cincinnati Childrens Hospital Medical Center Cincinnati Ohio
Children's Hospital of Philadelphia Philadelphia Pennsylvania
Texas Childrens Hospital Houston Texas
Perth Children's Hospital Perth Western Australia
UZ Gent Ghent Oost-Vlaanderen
Centre Leon Berard Lyon Auvergne-Rhône-Alpes
Institut Curie Paris France
Universitätsklinikum Köln Cologne Germany
Istituto Nazionale dei Tumori Milan Lombardy
National Cancer Center Hospital Chuo-ku Tokyo
Hospital Universitari Vall d'Hebron Barcelona Barcelona [Barcelona]
Hospital Infantil Universitario Niño Jesús Madrid Spain
Alder Hey Children's Hospital Liverpool United Kingdom

More Eli Lilly and Company trials in Japan

A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3) Active, not recruiting
A Study of LY4006896 in Healthy Participants and Participants With Parkinson's Disease Recruiting
A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors Active, not recruiting
A Study of Brenipatide in Adults Who Quit Smoking Cigarettes and Want to Avoid Relapse Recruiting
MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors Active, not recruiting
Official registry record

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.

View NCT04106219 on ClinicalTrials.gov ↗ ← All trials in Japan