LY3295668 Erbumine for Neuroblastoma

Palo Alto (17 mi)

Age: < 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Eli Lilly and Company

No Placebo Group

Trial Summary

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

Eligibility Criteria

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.

Inclusion Criteria

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

I can swallow pills.

Exclusion Criteria

I do not have any serious active diseases other than neuroblastoma.

I do not have untreated cancer in my brain or spinal cord.

I have not had a transplant of stem cells, bone marrow, or any organ.

I do not have symptoms of HIV or active hepatitis A, B, or C.

I have never been treated with aurora kinase inhibitors.

Treatment Details

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.

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).

Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Cytoxan for: