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Clinical Trial Finder

Search Results

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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 2 Years - 21 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04106219
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Eli Lilly and Company
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

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)
Principal Investigator Affiliation Eli Lilly and Company
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry, Other
Overall Status Active, not recruiting
Countries Australia, Belgium, France, Germany, Italy, Japan, Spain, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Neuroblastoma
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: LY3295668 Erbumine Escalation

LY3295668 Erbumine given orally.

Experimental: LY3295668 Erbumine + Topotecan + Cyclophosphamide Escalation

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

Experimental: LY3295668 Erbumine Expansion

LY3295668 Erbumine given orally.

Experimental: LY3295668 Erbumine + Topotecan + Cyclophosphamide Expansion

LY3295668 Erbumine given orally and topotecan and cyclophosphamide given IV.

Interventions

Drug: - LY3295668 Erbumine

Administered orally.

Drug: - Topotecan

Administered IV.

Drug: - Cyclophosphamide

Administered IV.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UCSF Medical Center at Mission Bay, San Francisco, California

Status

Address

UCSF Medical Center at Mission Bay

San Francisco, California, 94158

Children's Hospital Colorado, Aurora, Colorado

Status

Address

Children's Hospital Colorado

Aurora, Colorado, 80045

Chicago, Illinois

Status

Address

University of Chicago - Comer Children's Hospital

Chicago, Illinois, 60637

Dana-Farber Cancer Institute, Boston, Massachusetts

Status

Address

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115

Cincinnati, Ohio

Status

Address

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45229

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

Status

Address

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

Texas Childrens Hospital, Houston, Texas

Status

Address

Texas Childrens Hospital

Houston, Texas, 77030

International Sites

Perth Children's Hospital, Perth, Western Australia, Australia

Status

Address

Perth Children's Hospital

Perth, Western Australia, 6009

UZ Gent, Gent, Oost-Vlaanderen, Belgium

Status

Address

UZ Gent

Gent, Oost-Vlaanderen, 9000

Centre Leon Berard, Lyon, Rhône-Alpes, France

Status

Address

Centre Leon Berard

Lyon, Rhône-Alpes, 69373 CEDEX 08

Institut Curie, Paris CEDEX 05, France

Status

Address

Institut Curie

Paris CEDEX 05, , 75248

Universitätsklinikum Köln, Köln, Germany

Status

Address

Universitätsklinikum Köln

Köln, , 50924

Istituto Nazionale dei Tumori, Milano, Lombardie, Italy

Status

Address

Istituto Nazionale dei Tumori

Milano, Lombardie, 20133

National Cancer Center Hospital, Chuo-ku, Tokyo, Japan

Status

Address

National Cancer Center Hospital

Chuo-ku, Tokyo, 104-0045

Hospital Universitari Vall d'Hebron, Barcelona, Barcelona [Barcelona], Spain

Status

Address

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona], 8035

Madrid, Spain

Status

Address

Hospital Infantil Universitario Niño Jesús

Madrid, , 28009

Alder Hey Children's Hospital, Liverpool, United Kingdom

Status

Address

Alder Hey Children's Hospital

Liverpool, , L14 5AB

Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
  • Research Resources
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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