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

Primary Purpose

Neuroblastoma

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
LY3295668 Erbumine
Topotecan
Cyclophosphamide
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuroblastoma focused on measuring aurora kinase A, kinase, aurora A, aurora kinase inhibitor, aurora kinase A inhibitor, kinase inhibitor, AURKA, AurA, pediatric neuroblastoma, children

Eligibility Criteria

2 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCSF Medical Center at Mission Bay
  • The Children's Hospital for Cancer and Blood Disorders
  • University of Chicago - Comer Children's Hospital
  • Dana-Farber Cancer Institute
  • Cincinnati Childrens Hospital Medical Center
  • Children's Hospital of Philadelphia
  • Texas Childrens Hospital
  • Perth Children's Hospital
  • Universitair Ziekenhuis Gent
  • Centre Leon Berard
  • Institut Curie
  • Universitätsklinikum Köln
  • IRCCS Istituto Giannina Gaslini
  • Istituto Nazionale dei Tumori
  • Ospedale Regina Margherita di Torino
  • National Cancer Center Hospital
  • Hospital Universitari Vall d'Hebron
  • Hospital Infantil Universitario Niño Jesús
  • Hospital Universitario La Fe de Valencia
  • Leeds General Infirmary
  • Alder Hey Children's Hospital
  • Great Ormond Street Hospital For Children NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

LY3295668 Erbumine Escalation

LY3295668 Erbumine + Topotecan + Cyclophosphamide Escalation

LY3295668 Erbumine Expansion

LY3295668 Erbumine + Topotecan + Cyclophosphamide Expansion

Arm Description

LY3295668 Erbumine given orally.

LY3295668 Erbumine given orally and topotecan and cyclophosphamide given intravenously (IV).

LY3295668 Erbumine given orally.

LY3295668 Erbumine given orally and topotecan and cyclophosphamide given IV.

Outcomes

Primary Outcome Measures

Number of Participants with Dose Limiting Toxicities (DLTs)
Number of Participants with DLTs
Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
ORR
Duration of Response (DoR)
DoR

Secondary Outcome Measures

Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668
PK: AUC of LY3295668
PK: AUC of LY3295668 in Combination with Topotecan and Cyclophosphamide
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)
BOR
Progression-Free Survival (PFS)
PFS
Overall Survival (OS)
OS

Full Information

First Posted
September 25, 2019
Last Updated
September 25, 2023
Sponsor
Eli Lilly and Company
Collaborators
New Approaches to Neuroblastoma Therapy Consortium (NANT), Innovative Therapies for Children with Cancer in Europe (ITCC)
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1. Study Identification

Unique Protocol Identification Number
NCT04106219
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 11, 2020 (Actual)
Primary Completion Date
April 13, 2022 (Actual)
Study Completion Date
August 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
Collaborators
New Approaches to Neuroblastoma Therapy Consortium (NANT), Innovative Therapies for Children with Cancer in Europe (ITCC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroblastoma
Keywords
aurora kinase A, kinase, aurora A, aurora kinase inhibitor, aurora kinase A inhibitor, kinase inhibitor, AURKA, AurA, pediatric neuroblastoma, children

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LY3295668 Erbumine Escalation
Arm Type
Experimental
Arm Description
LY3295668 Erbumine given orally.
Arm Title
LY3295668 Erbumine + Topotecan + Cyclophosphamide Escalation
Arm Type
Experimental
Arm Description
LY3295668 Erbumine given orally and topotecan and cyclophosphamide given intravenously (IV).
Arm Title
LY3295668 Erbumine Expansion
Arm Type
Experimental
Arm Description
LY3295668 Erbumine given orally.
Arm Title
LY3295668 Erbumine + Topotecan + Cyclophosphamide Expansion
Arm Type
Experimental
Arm Description
LY3295668 Erbumine given orally and topotecan and cyclophosphamide given IV.
Intervention Type
Drug
Intervention Name(s)
LY3295668 Erbumine
Intervention Description
Administered orally.
Intervention Type
Drug
Intervention Name(s)
Topotecan
Intervention Description
Administered IV.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Administered IV.
Primary Outcome Measure Information:
Title
Number of Participants with Dose Limiting Toxicities (DLTs)
Description
Number of Participants with DLTs
Time Frame
Baseline through Cycle 2 (28 Day Cycle)
Title
Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
Description
ORR
Time Frame
Baseline through Measured Progressive Disease (Estimated up to 5 Years)
Title
Duration of Response (DoR)
Description
DoR
Time Frame
Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 5 Years)
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668
Description
PK: AUC of LY3295668
Time Frame
Cycle 1 Day 1 through Cycle 1 Day 15 (28 Day Cycles)
Title
PK: AUC of LY3295668 in Combination with Topotecan and Cyclophosphamide
Description
PK: AUC of LY3295668 in Combination with topotecan and cyclophosphamide
Time Frame
Cycle 1 Day 1 through Cycle 1 Day 15 (28 Day Cycles)
Title
Best Overall Response (BOR): Percentage of Participants with CR, PR, Stable Disease (SD), or Progressive Disease (PD)
Description
BOR
Time Frame
Baseline to Date of Objective Disease Progression (Estimated up to 5 Years)
Title
Progression-Free Survival (PFS)
Description
PFS
Time Frame
Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 5 Years)
Title
Overall Survival (OS)
Description
OS
Time Frame
Baseline to Date of Death from Any Cause (Estimated up to 6 Years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
UCSF Medical Center at Mission Bay
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
The Children's Hospital for Cancer and Blood Disorders
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Chicago - Comer Children's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Cincinnati Childrens Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Texas Childrens Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Perth Children's Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Universitair Ziekenhuis Gent
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Centre Leon Berard
City
Lyon
State/Province
Rhône-Alpes
ZIP/Postal Code
69008
Country
France
Facility Name
Institut Curie
City
Paris CEDEX 05
ZIP/Postal Code
75248
Country
France
Facility Name
Universitätsklinikum Köln
City
Köln
ZIP/Postal Code
50924
Country
Germany
Facility Name
IRCCS Istituto Giannina Gaslini
City
Genova
State/Province
Liguria
ZIP/Postal Code
16147
Country
Italy
Facility Name
Istituto Nazionale dei Tumori
City
Milano
State/Province
Lombardie
ZIP/Postal Code
20133
Country
Italy
Facility Name
Ospedale Regina Margherita di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
National Cancer Center Hospital
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
8035
Country
Spain
Facility Name
Hospital Infantil Universitario Niño Jesús
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Hospital Universitario La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Leeds General Infirmary
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
Alder Hey Children's Hospital
City
Liverpool
ZIP/Postal Code
L12 2AP
Country
United Kingdom
Facility Name
Great Ormond Street Hospital For Children NHS Foundation Trust
City
London
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/50gRHl2d9N02mw6yfhdI4Z
Description
A Study of LY3295668 Erbumine in Participants With Relapsed/Refractory Neuroblastoma

Learn more about this trial

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

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