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LY3295668 Erbumine for Neuroblastoma

Phase 1

Waitlist Available

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to date of death from any cause (estimated up to 6 years)

Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe for people with neuroblastoma that has come back or does not respond to treatment.

Who is the study for?

This trial is for people with neuroblastoma that has come back or didn't respond to treatment. They must have active cancer in bone, marrow, or soft tissue and be able to provide a tissue sample. Participants need to swallow pills but can't join if they've had certain transplants, untreated brain/spinal tumors, serious diseases besides cancer, absorption issues, prior aurora kinase inhibitor use, allergies to the drug, or symptomatic HIV/hepatitis.Check my eligibility

What is being tested?

The study is testing LY3295668 erbumine's safety for relapsed/refractory neuroblastoma patients. It involves taking this new medication alongside standard drugs Cyclophosphamide and Topotecan to see how well it works and what side effects occur.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system due to LY3295668 Erbumine; plus nausea, hair loss from Cyclophosphamide; and fatigue from Topotecan. Each patient may experience different side effects based on their individual health condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My neuroblastoma has returned or didn't respond to treatment, and I can provide a tissue sample.

Select...

I can swallow pills.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to date of death from any cause (estimated up to 6 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to date of death from any cause (estimated up to 6 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to date of death from any cause (estimated up to 6 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Duration of Response (DoR)

Number of Participants with Dose Limiting Toxicities (DLTs)

Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)

Secondary outcome measures

Best Overall Response (BOR): Percentage of Participants with CR, PR, Stable Disease (SD), or Progressive Disease (PD)

Overall Survival (OS)

PK: AUC of LY3295668 in Combination with Topotecan and Cyclophosphamide

+2 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: LY3295668 Erbumine ExpansionExperimental Treatment1 Intervention

LY3295668 Erbumine given orally.

Group II: LY3295668 Erbumine EscalationExperimental Treatment1 Intervention

LY3295668 Erbumine given orally.

Group III: LY3295668 Erbumine + Topotecan + Cyclophosphamide ExpansionExperimental Treatment3 Interventions

LY3295668 Erbumine given orally and topotecan and cyclophosphamide given IV.

Group IV: LY3295668 Erbumine + Topotecan + Cyclophosphamide EscalationExperimental Treatment3 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LY3295668 Erbumine

2019

Completed Phase 1

~60

Cyclophosphamide

1995

Completed Phase 3

~3780

Topotecan

2017

Completed Phase 3

~2400

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Innovative Therapies for Children with Cancer in Europe (ITCC)UNKNOWN

Eli Lilly and CompanyLead Sponsor

2,613 Previous Clinical Trials

3,200,858 Total Patients Enrolled

2 Trials studying Neuroblastoma

189 Patients Enrolled for Neuroblastoma

New Approaches to Neuroblastoma Therapy Consortium (NANT)UNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any precedents of research on the effects of LY3295668 Erbumine?

"LY3295668 Erbumine was introduced to the academic research community in 1997 at City of Hope Comprehensive Cancer Center. Presently, 1,215 studies are finished and 853 more trials are still ongoing worldwide; many of these occur at Aurora, Colorado's medical centre."

Answered by AI

Is it possible to register for this medical experiment?

"To be eligible for this medical trial, participants should have a diagnosis of neuroblastoma and fall between the ages of 2 to 21. 71 individuals are required for enrollment."

Answered by AI

What are the main goals of this trial?

"Eli Lilly and Company, the sponsor of the trial, has specified that Number of Participants with Dose Limiting Toxicities (DLTs) will be measured over an estimated 5-year period. Additionally, researchers plan to assess Progression-Free Survival (PFS), Best Overall Response (BOR): Percentage of Participants with CR, PR, Stable Disease (SD), or Progressive Disease (PD), as well as Overall Survival (OS)."

Answered by AI

Is this clinical experiment open to participants aged 85 and over?

"To be eligible for this medical trial, participants must range between the ages of two and twenty-one."

Answered by AI

Has the Food and Drug Administration accepted LY3295668 Erbumine as a viable medication?

"Due to the limited evidence backing LY3295668 Erbumine's efficacy and safety, our team has assigned it a score of 1 on the risk-scale."

Answered by AI

What is the size of the cohort being assessed by this research study?

"This medical research is no longer recruiting patients; the trial was first published on June 11th 2020 and last updated August 17th 2022. However, there are 161 studies looking for participants with neuroblastoma and 853 clinical trials actively enrolling persons for LY3295668 Erbumine."

Answered by AI

Can any additional participants enroll in this research endeavor?

"This particular clinical trial is now closed. It was initially posted on June 11th 2020, and the last modifications were made on August 17th 2022. If you are wanting to find alternative studies, there are currently 161 medical trials that require enrollment of neuroblastoma patients and 853 for LY3295668 Erbumine participants."

Answered by AI

What afflictions has LY3295668 Erbumine been shown to alleviate?

"LY3295668 Erbumine has the capacity to be a therapeutic for multiple sclerosis and other illnesses, such as leukemia, myelocytic acute sarcoma, and retinoblastoma."

Answered by AI

How extensive is the geographic reach of this trial?

"This research project is being conducted at The Children's Hospital for Cancer and Blood Disorders in Aurora, Colorado, University of Chicago - Comer Children's Hospital in Chicago, Illinois and other sites across the United States. Moreover, it has been extended to include a branch located within Children's Healthcare of Atlanta, Inc. at Egleston in Georgia."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "A Study of LY3295668 Erbumine in Participants With Relapsed/Refractory Neuroblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04106219.

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