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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.
Must not have
Participants must not have a serious active disease other than neuroblastoma.
Participants must not have untreated tumor that has spread to the brain or spinal cord.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to date of death from any cause (estimated up to 6 years)
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowSelect...
My neuroblastoma has returned or didn't respond to treatment, and I can provide a tissue sample.
Select...
I can swallow pills.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any serious active diseases other than neuroblastoma.
Select...
I do not have untreated cancer in my brain or spinal cord.
Select...
I have not had a transplant of stem cells, bone marrow, or any organ.
Select...
I do not have symptoms of HIV or active hepatitis A, B, or C.
Select...
I have never been treated with aurora kinase inhibitors.
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)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Topotecan
2017
Completed Phase 3
~2890
Cyclophosphamide
2010
Completed Phase 4
~2310
LY3295668 Erbumine
2019
Completed Phase 1
~60
Find a Location
Who is running the clinical trial?
Innovative Therapies for Children with Cancer in Europe (ITCC)UNKNOWN
Eli Lilly and CompanyLead Sponsor
2,679 Previous Clinical Trials
3,465,682 Total Patients Enrolled
2 Trials studying Neuroblastoma
189 Patients Enrolled for Neuroblastoma
New Approaches to Neuroblastoma Therapy Consortium (NANT)UNKNOWN
Study DirectorEli Lilly and Company
1,389 Previous Clinical Trials
428,097 Total Patients Enrolled
1 Trials studying Neuroblastoma
117 Patients Enrolled for Neuroblastoma