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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04106219
Recruitment Status : Active, not recruiting
First Posted : September 26, 2019
Last Update Posted : March 25, 2024
Sponsor:
Collaborators:
New Approaches to Neuroblastoma Therapy Consortium (NANT)
Innovative Therapies for Children with Cancer in Europe (ITCC)
Information provided by (Responsible Party):
Eli Lilly and Company

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

Condition or disease Intervention/treatment Phase
Neuroblastoma Drug: LY3295668 Erbumine Drug: Topotecan Drug: Cyclophosphamide Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 11, 2020
Actual Primary Completion Date : April 13, 2022
Estimated Study Completion Date : August 25, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Neuroblastoma
Drug Information available for: Topotecan

Arms and Interventions
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Arm Intervention/treatment
Experimental: LY3295668 Erbumine Escalation
LY3295668 Erbumine given orally.
 Drug: LY3295668 Erbumine
Administered orally.
Experimental: LY3295668 Erbumine + Topotecan + Cyclophosphamide Escalation
LY3295668 Erbumine given orally and topotecan and cyclophosphamide given intravenously (IV).
 Drug: LY3295668 Erbumine
Administered orally.

Drug: Topotecan
Administered IV.

Drug: Cyclophosphamide
Administered IV.
Experimental: LY3295668 Erbumine Expansion
LY3295668 Erbumine given orally.
 Drug: LY3295668 Erbumine
Administered orally.
Experimental: LY3295668 Erbumine + Topotecan + Cyclophosphamide Expansion
LY3295668 Erbumine given orally and topotecan and cyclophosphamide given IV.
 Drug: LY3295668 Erbumine
Administered orally.

Drug: Topotecan
Administered IV.

Drug: Cyclophosphamide
Administered IV.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Baseline through Cycle 2 (28 Day Cycle) ]
    Number of Participants with DLTs

  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) ]
    ORR

  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) ]
    DoR


Secondary Outcome Measures :
  1. 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) ]
    PK: AUC of LY3295668

  2. PK: AUC of LY3295668 in Combination with Topotecan and Cyclophosphamide [ Time Frame: Cycle 1 Day 1 through Cycle 1 Day 15 (28 Day Cycles) ]
    PK: AUC of LY3295668 in Combination with topotecan and cyclophosphamide

  3. 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) ]
    BOR

  4. Progression-Free Survival (PFS) [ Time Frame: Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 5 Years) ]
    PFS

  5. Overall Survival (OS) [ Time Frame: Baseline to Date of Death from Any Cause (Estimated up to 6 Years) ]
    OS


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04106219


Locations
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Sponsors and Collaborators
Eli Lilly and Company
New Approaches to Neuroblastoma Therapy Consortium (NANT)
Innovative Therapies for Children with Cancer in Europe (ITCC)
Investigators
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Study Director: Call 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
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04106219    
Other Study ID Numbers: 17295
J1O-MC-JZHD ( Other Identifier: Eli Lilly and Company )
2019-001042-18 ( EudraCT Number )
2019-01 ( Other Identifier: NANT )
ITCC-085 ( Other Identifier: ITCC )
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: March 25, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
aurora kinase A
kinase
aurora A
aurora kinase inhibitor
aurora kinase A inhibitor
 kinase inhibitor
AURKA
AurA
pediatric neuroblastoma
children
Additional relevant MeSH terms:
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Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Cyclophosphamide
Topotecan
 Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors