Description:
The reason for this study is to see if the study drug LY3295668 erbumine is safe in
participants with relapsed/refractory neuroblastoma.
Title
- Brief Title: A Study of LY3295668 Erbumine in Participants With Relapsed/Refractory Neuroblastoma
- Official Title: A Phase 1 Study of Aurora Kinase A Inhibitor LY3295668 Erbumine as a Single Agent and in Combination in Patients With Relapsed/Refractory Neuroblastoma
Clinical Trial IDs
- ORG STUDY ID:
17295
- SECONDARY ID:
J1O-MC-JZHD
- SECONDARY ID:
2019-001042-18
- SECONDARY ID:
2019-01
- SECONDARY ID:
ITCC-085
- NCT ID:
NCT04106219
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| LY3295668 Erbumine | | LY3295668 Erbumine + Topotecan + Cyclophosphamide Escalation |
| Topotecan | | LY3295668 Erbumine + Topotecan + Cyclophosphamide Escalation |
| Cyclophosphamide | | LY3295668 Erbumine + Topotecan + Cyclophosphamide Escalation |
Purpose
The reason for this study is to see if the study drug LY3295668 erbumine is safe in
participants with relapsed/refractory neuroblastoma.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| LY3295668 Erbumine Escalation | Experimental | LY3295668 Erbumine given orally. | |
| LY3295668 Erbumine + Topotecan + Cyclophosphamide Escalation | Experimental | LY3295668 Erbumine given orally and topotecan and cyclophosphamide given intravenously (IV). | - LY3295668 Erbumine
- Topotecan
- Cyclophosphamide
|
| LY3295668 Erbumine Expansion | Experimental | LY3295668 Erbumine given orally. | |
| LY3295668 Erbumine + Topotecan + Cyclophosphamide Expansion | Experimental | LY3295668 Erbumine given orally and topotecan and cyclophosphamide given IV. | - LY3295668 Erbumine
- Topotecan
- Cyclophosphamide
|
Eligibility Criteria
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.
| Maximum Eligible Age: | 21 Years |
| Minimum Eligible Age: | 2 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Number of Participants with Dose Limiting Toxicities (DLTs) |
| Time Frame: | Baseline through Cycle 2 (28 Day Cycle) |
| Safety Issue: | |
| Description: | Number of Participants with DLTs |
Secondary Outcome Measures
| Measure: | Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668 |
| Time Frame: | Cycle 1 Day 1 through Cycle 1 Day 15 (28 Day Cycles) |
| Safety Issue: | |
| Description: | PK: AUC of LY3295668 |
| Measure: | PK: AUC of LY3295668 in Combination with Topotecan and Cyclophosphamide |
| Time Frame: | Cycle 1 Day 1 through Cycle 1 Day 15 (28 Day Cycles) |
| Safety Issue: | |
| Description: | PK: AUC of LY3295668 in Combination with topotecan and cyclophosphamide |
| Measure: | Best Overall Response (BOR): Percentage of Participants with CR, PR, Stable Disease (SD), or Progressive Disease (PD) |
| Time Frame: | Baseline to Date of Objective Disease Progression (Estimated up to 5 Years) |
| Safety Issue: | |
| Description: | BOR |
| Measure: | Progression-Free Survival (PFS) |
| Time Frame: | Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 5 Years) |
| Safety Issue: | |
| Description: | PFS |
| Measure: | Overall Survival (OS) |
| Time Frame: | Baseline to Date of Death from Any Cause (Estimated up to 6 Years) |
| Safety Issue: | |
| Description: | OS |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Eli Lilly and Company |
Trial Keywords
- aurora kinase A
- kinase
- aurora A
- aurora kinase inhibitor
- aurora kinase A inhibitor
- kinase inhibitor
- AURKA
- AurA
- pediatric neuroblastoma
- children
Last Updated
August 18, 2021
