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

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04106219

Collaborator

New Approaches to Neuroblastoma Therapy Consortium (NANT) (Other), Innovative Therapies for Children with Cancer in Europe (ITCC) (Other)

Enrollment

Locations

Arms

38.4

Anticipated Duration (Months)

3.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Neuroblastoma	Drug: LY3295668 Erbumine Drug: Topotecan Drug: Cyclophosphamide	Phase 1

Study Design

Study Type:

Interventional

Anticipated 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 :

Jun 11, 2020

Actual Primary Completion Date :

Apr 13, 2022

Anticipated Study Completion Date :

Aug 25, 2023

Arms and Interventions

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

Primary Outcome Measures

Number of Participants with Dose Limiting Toxicities (DLTs) [Baseline through Cycle 2 (28 Day Cycle)]
Number of Participants with DLTs
Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) [Baseline through Measured Progressive Disease (Estimated up to 5 Years)]
ORR
Duration of Response (DoR) [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

Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668 [Cycle 1 Day 1 through Cycle 1 Day 15 (28 Day Cycles)]
PK: AUC of LY3295668
PK: AUC of LY3295668 in Combination with Topotecan and Cyclophosphamide [Cycle 1 Day 1 through Cycle 1 Day 15 (28 Day Cycles)]
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) [Baseline to Date of Objective Disease Progression (Estimated up to 5 Years)]
BOR
Progression-Free Survival (PFS) [Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 5 Years)]
PFS
Overall Survival (OS) [Baseline to Date of Death from Any Cause (Estimated up to 6 Years)]
OS

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 21 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSF Medical Center at Mission Bay	San Francisco	California	United States	94158
2	The Children's Hospital for Cancer and Blood Disorders	Aurora	Colorado	United States	80045
3	University of Chicago - Comer Children's Hospital	Chicago	Illinois	United States	60637
4	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02215
5	Cincinnati Childrens Hospital Medical Center	Cincinnati	Ohio	United States	45229
6	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
7	Texas Childrens Hospital	Houston	Texas	United States	77030
8	Perth Children's Hospital	Perth	Western Australia	Australia	6009
9	Universitair Ziekenhuis Gent	Gent	Oost-Vlaanderen	Belgium	9000
10	Centre Leon Berard	Lyon	Rhône-Alpes	France	69008
11	Institut Curie	Paris CEDEX 05		France	75248
12	Universitätsklinikum Köln	Köln		Germany	50924
13	IRCCS Istituto Giannina Gaslini	Genova	Liguria	Italy	16147
14	Istituto Nazionale dei Tumori	Milano	Lombardie	Italy	20133
15	Ospedale Regina Margherita di Torino	Torino		Italy	10126
16	National Cancer Center Hospital	Chuo-ku	Tokyo	Japan	104-0045
17	Hospital Universitari Vall d'Hebron	Barcelona	Barcelona [Barcelona]	Spain	8035
18	Hospital Infantil Universitario Niño Jesús	Madrid		Spain	28009
19	Hospital Universitario La Fe de Valencia	Valencia		Spain	46026
20	Leeds General Infirmary	Leeds		United Kingdom	LS1 3EX
21	Alder Hey Children's Hospital	Liverpool		United Kingdom	L12 2AP
22	Great Ormond Street Hospital For Children NHS Foundation Trust	London		United Kingdom	WC1N 3JH

Sponsors and Collaborators

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

Investigators

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