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

Neuroblastoma Clinical Trial

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 Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04106219
• Other study ID #: 17295
• Secondary ID: J1O-MC-JZHD2019-
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: June 11, 2020
• Est. completion date: August 25, 2024

Study information

• Verified date: March 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 71
• Est. completion date: August 25, 2024
• Est. primary completion date: April 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neuroblastoma

Intervention

Drug:
• LY3295668 Erbumine
Administered orally.
• Topotecan
Administered IV.
• Cyclophosphamide
Administered IV.

Locations

Country	Name	City	State
Australia	Perth Children's Hospital	Perth	Western Australia
Belgium	UZ Gent	Gent	Oost-Vlaanderen
France	Centre Leon Berard	Lyon	Rhône-Alpes
France	Institut Curie	Paris CEDEX 05
Germany	Universitätsklinikum Köln	Köln
Italy	Istituto Nazionale dei Tumori	Milano	Lombardie
Japan	National Cancer Center Hospital	Chuo-ku	Tokyo
Spain	Hospital Universitari Vall d'Hebron	Barcelona	Barcelona [Barcelona]
Spain	Hospital Infantil Universitario Niño Jesús	Madrid
United Kingdom	Alder Hey Children's Hospital	Liverpool
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	University of Chicago - Comer Children's Hospital	Chicago	Illinois
United States	Cincinnati Childrens Hospital Medical Center	Cincinnati	Ohio
United States	Texas Childrens Hospital	Houston	Texas
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	UCSF Medical Center at Mission Bay	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
Eli Lilly and Company	Innovative Therapies for Children with Cancer in Europe (ITCC), New Approaches to Neuroblastoma Therapy Consortium (NANT)

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  France,  Germany,  Italy,  Japan,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Dose Limiting Toxicities (DLTs)	Number of Participants with DLTs	Baseline through Cycle 2 (28 Day Cycle)
Primary	Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)	ORR	Baseline through Measured Progressive Disease (Estimated up to 5 Years)
Primary	Duration of Response (DoR)	DoR	Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 5 Years)
Secondary	Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668	PK: AUC of LY3295668	Cycle 1 Day 1 through Cycle 1 Day 15 (28 Day Cycles)
Secondary	PK: AUC of LY3295668 in Combination with Topotecan and Cyclophosphamide	PK: AUC of LY3295668 in Combination with topotecan and cyclophosphamide	Cycle 1 Day 1 through Cycle 1 Day 15 (28 Day Cycles)
Secondary	Best Overall Response (BOR): Percentage of Participants with CR, PR, Stable Disease (SD), or Progressive Disease (PD)	BOR	Baseline to Date of Objective Disease Progression (Estimated up to 5 Years)
Secondary	Progression-Free Survival (PFS)	PFS	Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 5 Years)
Secondary	Overall Survival (OS)	OS	Baseline to Date of Death from Any Cause (Estimated up to 6 Years)

External Links

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