A Study of LY3295668 Erbumine in Participants With Relapsed/Refractory Neuroblastoma
- Conditions
- Patieints with relapsed/refractory neuroblastoma
- Registration Number
- JPRN-jRCT2031200270
- Lead Sponsor
- Masaki Takeshi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 5
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.
- 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.
- Participant s 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Baseline through Cycle 2 (28 Day Cycle) ]<br>Number of Participants with DLTs<br>2. Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) [ Time Frame: Baseline through Measured Progressive Disease (Estimated up to 5 Years) ]<br>ORR<br>3. Duration of Response (DoR) [ Time Frame: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 5 Years) ]<br>DoR
- Secondary Outcome Measures
Name Time Method