Clinical Trials /

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

NCT04106219

Description:

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

Related Conditions:
  • Neuroblastoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

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

  • Neuroblastoma

Interventions

DrugSynonymsArms
LY3295668 ErbumineLY3295668 Erbumine Escalation
TopotecanLY3295668 Erbumine + Topotecan + Cyclophosphamide Escalation
CyclophosphamideLY3295668 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

NameTypeDescriptionInterventions
LY3295668 Erbumine EscalationExperimentalLY3295668 Erbumine given orally.
  • LY3295668 Erbumine
LY3295668 Erbumine + Topotecan + Cyclophosphamide EscalationExperimentalLY3295668 Erbumine given orally and topotecan and cyclophosphamide given intravenously (IV).
  • LY3295668 Erbumine
  • Topotecan
  • Cyclophosphamide
LY3295668 Erbumine ExpansionExperimentalLY3295668 Erbumine given orally.
  • LY3295668 Erbumine
LY3295668 Erbumine + Topotecan + Cyclophosphamide ExpansionExperimentalLY3295668 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 more than 3 treatment regimens given after frontline
             initial therapy.

          -  Participants must not have had prior allogeneic 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:Not yet 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

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