Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT04106219 for Neuroblastoma is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
One study matched filter criteria
Card View
Back to Search
Eli Lilly and CompanyA Study of LY3295668 Erbumine in Participants With Relapsed/Refractory Neuroblastoma Phase 1 71
Clinical Trial NCT04106219 is designed to study Treatment for Neuroblastoma. It is a Phase 1 interventional study that is active, not recruiting, having started on June 11, 2020, with plans to enroll 71 participants. Led by Eli Lilly and Company, it is expected to complete by August 1, 2026. The latest data from ClinicalTrials.gov was last updated on July 23, 2025.
Brief Summary
The reason for this study is to see if the study drug LY3295668 erbumine is safe 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
Conditions
NeuroblastomaOther Study IDs
- 17295
- J1O-MC-JZHD (Other Identifier) (Eli Lilly and Company)
- 2019-001042-18 (EudraCT Number)
- 2019-01 (Other Identifier) (NANT)
- ITCC-085 (Other Identifier) (ITCC)
NCT ID Number
Start Date (Actual)
2020-06-11
Last Update Posted
2025-07-23
Completion Date (Estimated)
2026-08
Enrollment (Estimated)
71
Study Type
Interventional
PHASE
Phase 1
Status
Active, not recruiting
Keywords
aurora kinase A
kinase
aurora A
aurora kinase inhibitor
aurora kinase A inhibitor
kinase inhibitor
AURKA
AurA
pediatric neuroblastoma
children
kinase
aurora A
aurora kinase inhibitor
aurora kinase A inhibitor
kinase inhibitor
AURKA
AurA
pediatric neuroblastoma
children
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalLY3295668 Erbumine Escalation LY3295668 Erbumine given orally. | LY3295668 Erbumine Administered orally. |
ExperimentalLY3295668 Erbumine + Topotecan + Cyclophosphamide Escalation LY3295668 Erbumine given orally and topotecan and cyclophosphamide given intravenously (IV). | LY3295668 Erbumine Administered orally. Topotecan Administered IV. Cyclophosphamide Administered IV. |
ExperimentalLY3295668 Erbumine Expansion LY3295668 Erbumine given orally. | LY3295668 Erbumine Administered orally. |
ExperimentalLY3295668 Erbumine + Topotecan + Cyclophosphamide Expansion LY3295668 Erbumine given orally and topotecan and cyclophosphamide given IV. | LY3295668 Erbumine Administered orally. Topotecan Administered IV. Cyclophosphamide Administered IV. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Number of Participants with Dose Limiting Toxicities (DLTs) | Number of Participants with DLTs | Baseline through Cycle 2 (28 Day Cycle) |
Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) | ORR | Baseline through Measured Progressive Disease (Estimated up to 5 Years) |
Duration of Response (DoR) | DoR | Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 5 Years) |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668 | PK: AUC of LY3295668 | Cycle 1 Day 1 through Cycle 1 Day 15 (28 Day Cycles) |
PK: AUC of LY3295668 in Combination with Topotecan and Cyclophosphamide | PK: AUC of LY3295668 in Combination with topotecan and cyclophosphamide | Cycle 1 Day 1 through Cycle 1 Day 15 (28 Day Cycles) |
Best Overall Response (BOR): Percentage of Participants with CR, PR, Stable Disease (SD), or Progressive Disease (PD) | BOR | Baseline to Date of Objective Disease Progression (Estimated up to 5 Years) |
Progression-Free Survival (PFS) | PFS | Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 5 Years) |
Overall Survival (OS) | OS | Baseline to Date of Death from Any Cause (Estimated up to 6 Years) |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child, Adult
Minimum Age
2 Years
Eligible Sexes
All
- 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.
- 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.
Eli Lilly and Company362 active studies to explore- New Approaches to Neuroblastoma Therapy Consortium (NANT)
- Innovative Therapies for Children with Cancer in Europe (ITCC)
No contact data.
17 Study Locations in 9 Countries
California
UCSF Medical Center at Mission Bay, San Francisco, California, 94158, United States
Colorado
Children's Hospital Colorado, Aurora, Colorado, 80045, United States
Illinois
University of Chicago - Comer Children's Hospital, Chicago, Illinois, 60637, United States
Massachusetts
Dana-Farber Cancer Institute, Boston, Massachusetts, 02115, United States
Ohio
Cincinnati Childrens Hospital Medical Center, Cincinnati, Ohio, 45229, United States
Pennsylvania
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States
Texas
Texas Childrens Hospital, Houston, Texas, 77030, United States
Western Australia
Perth Children's Hospital, Perth, Western Australia, 6009, Australia
Oost-Vlaanderen
UZ Gent, Ghent, Oost-Vlaanderen, 9000, Belgium
Auvergne-Rhône-Alpes
Centre Leon Berard, Lyon, Auvergne-Rhône-Alpes, 69373 CEDEX 08, France
Institut Curie, Paris, 75248, France
Universitätsklinikum Köln, Cologne, 50924, Germany
Lombardy
Istituto Nazionale dei Tumori, Milan, Lombardy, 20133, Italy
Tokyo
National Cancer Center Hospital, Chuo-ku, Tokyo, 104-0045, Japan
Barcelona [Barcelona]
Hospital Universitari Vall d'Hebron, Barcelona, Barcelona [Barcelona], 8035, Spain
Hospital Infantil Universitario Niño Jesús, Madrid, 28009, Spain
Alder Hey Children's Hospital, Liverpool, L14 5AB, United Kingdom