A Study of LY3295668 Erbumine in Participants With Relapsed/Refractory Neuroblastoma
NCT ID: NCT04106219
Last Updated: 2025-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
71 participants
INTERVENTIONAL
2020-06-11
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LY3295668 Erbumine Escalation
LY3295668 Erbumine given orally.
LY3295668 Erbumine
Administered orally.
LY3295668 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.
LY3295668 Erbumine Expansion
LY3295668 Erbumine given orally.
LY3295668 Erbumine
Administered orally.
LY3295668 Erbumine + Topotecan + Cyclophosphamide Expansion
LY3295668 Erbumine given orally and topotecan and cyclophosphamide given IV.
LY3295668 Erbumine
Administered orally.
Topotecan
Administered IV.
Cyclophosphamide
Administered IV.
Interventions
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LY3295668 Erbumine
Administered orally.
Topotecan
Administered IV.
Cyclophosphamide
Administered IV.
Eligibility Criteria
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Inclusion Criteria
* Participants must be able to swallow capsules.
Exclusion Criteria
* 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.
2 Years
21 Years
ALL
No
Sponsors
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New Approaches to Neuroblastoma Therapy Consortium (NANT)
UNKNOWN
Innovative Therapies for Children with Cancer in Europe (ITCC)
UNKNOWN
Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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UCSF Medical Center at Mission Bay
San Francisco, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
University of Chicago - Comer Children's Hospital
Chicago, Illinois, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Texas Childrens Hospital
Houston, Texas, United States
Perth Children's Hospital
Perth, Western Australia, Australia
UZ Gent
Ghent, Oost-Vlaanderen, Belgium
Centre Leon Berard
Lyon, Auvergne-Rhône-Alpes, France
Institut Curie
Paris, , France
Universitätsklinikum Köln
Cologne, , Germany
Istituto Nazionale dei Tumori
Milan, Lombardy, Italy
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], Spain
Hospital Infantil Universitario Niño Jesús
Madrid, , Spain
Alder Hey Children's Hospital
Liverpool, , United Kingdom
Countries
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Related Links
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A Study of LY3295668 Erbumine in Participants With Relapsed/Refractory Neuroblastoma
Other Identifiers
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J1O-MC-JZHD
Identifier Type: OTHER
Identifier Source: secondary_id
2019-001042-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2019-01
Identifier Type: OTHER
Identifier Source: secondary_id
ITCC-085
Identifier Type: OTHER
Identifier Source: secondary_id
17295
Identifier Type: -
Identifier Source: org_study_id
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