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

NCT ID: NCT04106219

Last Updated: 2025-07-23

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-11

Study Completion Date

2026-08-31

Brief Summary

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

Detailed Description

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Conditions

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Neuroblastoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LY3295668 Erbumine Escalation

LY3295668 Erbumine given orally.

Group Type EXPERIMENTAL

LY3295668 Erbumine

Intervention Type DRUG

Administered orally.

LY3295668 Erbumine + Topotecan + Cyclophosphamide Escalation

LY3295668 Erbumine given orally and topotecan and cyclophosphamide given intravenously (IV).

Group Type EXPERIMENTAL

LY3295668 Erbumine

Intervention Type DRUG

Administered orally.

Topotecan

Intervention Type DRUG

Administered IV.

Cyclophosphamide

Intervention Type DRUG

Administered IV.

LY3295668 Erbumine Expansion

LY3295668 Erbumine given orally.

Group Type EXPERIMENTAL

LY3295668 Erbumine

Intervention Type DRUG

Administered orally.

LY3295668 Erbumine + Topotecan + Cyclophosphamide Expansion

LY3295668 Erbumine given orally and topotecan and cyclophosphamide given IV.

Group Type EXPERIMENTAL

LY3295668 Erbumine

Intervention Type DRUG

Administered orally.

Topotecan

Intervention Type DRUG

Administered IV.

Cyclophosphamide

Intervention Type DRUG

Administered IV.

Interventions

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LY3295668 Erbumine

Administered orally.

Intervention Type DRUG

Topotecan

Administered IV.

Intervention Type DRUG

Cyclophosphamide

Administered IV.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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New Approaches to Neuroblastoma Therapy Consortium (NANT)

UNKNOWN

Sponsor Role collaborator

Innovative Therapies for Children with Cancer in Europe (ITCC)

UNKNOWN

Sponsor Role collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Children's Hospital Colorado

Aurora, Colorado, United States

Site Status

University of Chicago - Comer Children's Hospital

Chicago, Illinois, United States

Site Status

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Texas Childrens Hospital

Houston, Texas, United States

Site Status

Perth Children's Hospital

Perth, Western Australia, Australia

Site Status

UZ Gent

Ghent, Oost-Vlaanderen, Belgium

Site Status

Centre Leon Berard

Lyon, Auvergne-Rhône-Alpes, France

Site Status

Institut Curie

Paris, , France

Site Status

Universitätsklinikum Köln

Cologne, , Germany

Site Status

Istituto Nazionale dei Tumori

Milan, Lombardy, Italy

Site Status

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Site Status

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona], Spain

Site Status

Hospital Infantil Universitario Niño Jesús

Madrid, , Spain

Site Status

Alder Hey Children's Hospital

Liverpool, , United Kingdom

Site Status

Countries

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United States Australia Belgium France Germany Italy Japan Spain United Kingdom

Related Links

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https://trials.lillytrialguide.com/en-US/trial/50gRHl2d9N02mw6yfhdI4Z

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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