Active — Not RecruitingPhase 1

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

United States71 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 range2 Years – 21 Years

SexALL

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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.

What they're measuring

Number of Participants with Dose Limiting Toxicities (DLTs)

Timeframe: Baseline through Cycle 2 (28 Day Cycle)

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)

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)

Trial details

NCT IDNCT04106219

SponsorEli Lilly and Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-04-13

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