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
5 other identifiers
interventional
71
9 countries
17
Brief Summary
The reason for this study is to see if the study drug LY3295668 erbumine is safe in participants with relapsed/refractory neuroblastoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2020
Longer than P75 for phase_1
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2019
CompletedFirst Posted
Study publicly available on registry
September 26, 2019
CompletedStudy Start
First participant enrolled
June 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 13, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
ExpectedApril 21, 2026
April 1, 2026
1.8 years
September 25, 2019
April 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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)
Secondary Outcomes (5)
Pharmacokinetics (PK): Area Under the Concentration Time Curve (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
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)
Baseline to Date of Objective Disease Progression (Estimated up to 5 Years)
Progression-Free Survival (PFS)
Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 5 Years)
Overall Survival (OS)
Baseline to Date of Death from Any Cause (Estimated up to 6 Years)
Study Arms (4)
LY3295668 Erbumine Escalation
EXPERIMENTALLY3295668 Erbumine given orally.
LY3295668 Erbumine + Topotecan + Cyclophosphamide Escalation
EXPERIMENTALLY3295668 Erbumine given orally and topotecan and cyclophosphamide given intravenously (IV).
LY3295668 Erbumine Expansion
EXPERIMENTALLY3295668 Erbumine given orally.
LY3295668 Erbumine + Topotecan + Cyclophosphamide Expansion
EXPERIMENTALLY3295668 Erbumine given orally and topotecan and cyclophosphamide given IV.
Interventions
Administered orally.
Administered IV.
Administered IV.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
UCSF Medical Center at Mission Bay
San Francisco, California, 94158, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
University of Chicago - Comer Children's Hospital
Chicago, Illinois, 60637, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Texas Childrens Hospital
Houston, Texas, 77030, United States
Perth Children's Hospital
Perth, Western Australia, 6009, Australia
UZ Gent
Ghent, Oost-Vlaanderen, 9000, Belgium
Centre Leon Berard
Lyon, Auvergne-Rhône-Alpes, 69373 CEDEX 08, France
Institut Curie
Paris, 75248, France
Universitätsklinikum Köln
Cologne, 50924, Germany
Istituto Nazionale dei Tumori
Milan, Lombardy, 20133, Italy
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045, Japan
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2019
First Posted
September 26, 2019
Study Start
June 11, 2020
Primary Completion
April 13, 2022
Study Completion (Estimated)
August 1, 2026
Last Updated
April 21, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share