Neuroblastoma
Conditions
Keywords
aurora kinase A, kinase, aurora A, aurora kinase inhibitor, aurora kinase A inhibitor, kinase inhibitor, AURKA, AurA, pediatric neuroblastoma, children
Brief summary
The reason for this study is to see if the study drug LY3295668 erbumine is safe in participants with relapsed/refractory neuroblastoma.
Interventions
Administered orally.
DRUGTopotecan
Administered IV.
DRUGCyclophosphamide
Administered IV.
Sponsors
Eli Lilly and Company
New Approaches to Neuroblastoma Therapy Consortium
Innovative Therapies for Children with Cancer in Europe (ITCC)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 21 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Dose Limiting Toxicities (DLTs) | Baseline through Cycle 2 (28 Day Cycle) | Number of Participants with DLTs |
| Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) | Baseline through Measured Progressive Disease (Estimated up to 5 Years) | ORR |
| Duration of Response (DoR) | Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 5 Years) | DoR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668 | Cycle 1 Day 1 through Cycle 1 Day 15 (28 Day Cycles) | PK: AUC of LY3295668 |
| PK: AUC of LY3295668 in Combination with Topotecan and Cyclophosphamide | Cycle 1 Day 1 through Cycle 1 Day 15 (28 Day Cycles) | PK: AUC of LY3295668 in Combination with topotecan and cyclophosphamide |
| Best Overall Response (BOR): Percentage of Participants with CR, PR, Stable Disease (SD), or Progressive Disease (PD) | Baseline to Date of Objective Disease Progression (Estimated up to 5 Years) | BOR |
| Progression-Free Survival (PFS) | Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 5 Years) | PFS |
| Overall Survival (OS) | Baseline to Date of Death from Any Cause (Estimated up to 6 Years) | OS |
Countries
Australia, Belgium, France, Germany, Italy, Japan, Spain, United Kingdom, United States
Contacts
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed