A Study of LY3295668 Erbumine in Participants With Relapsed/Refractory Neuroblastoma (NCT04106219) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study of LY3295668 Erbumine in Participants With Relapsed/Refractory Neuroblastoma
United States, Australia, Belgium71 participantsStarted 2020-06-11
Plain-language summary
The reason for this study is to see if the study drug LY3295668 erbumine is safe in participants with relapsed/refractory neuroblastoma.
Who can participate
Age range
2 Years – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with Dose Limiting Toxicities (DLTs)
Timeframe: Baseline through Cycle 2 (28 Day Cycle)
2
Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
Timeframe: Baseline through Measured Progressive Disease (Estimated up to 5 Years)
3
Duration of Response (DoR)
Timeframe: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 5 Years)