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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04106219




Registration number
NCT04106219
Ethics application status
Date submitted
25/09/2019
Date registered
26/09/2019
Date last updated
17/06/2020

Titles & IDs
Public title
A Study of LY3295668 Erbumine in Participants With Relapsed/Refractory Neuroblastoma
Scientific 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
Secondary ID [1] 0 0
J1O-MC-JZHD
Secondary ID [2] 0 0
17295
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuroblastoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Neuroendocrine tumour (NET)
Cancer 0 0 0 0
Children's - Other

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LY3295668 Erbumine
Treatment: Drugs - Topotecan
Treatment: Drugs - Cyclophosphamide

Experimental: LY3295668 Erbumine Escalation - LY3295668 Erbumine given orally.

Experimental: LY3295668 Erbumine + Topotecan + Cyclophosphamide Escalation - LY3295668 Erbumine given orally and topotecan and cyclophosphamide given intravenously (IV).

Experimental: LY3295668 Erbumine Expansion - LY3295668 Erbumine given orally.

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


Treatment: Drugs: LY3295668 Erbumine
Administered orally.

Treatment: Drugs: Topotecan
Administered IV.

Treatment: Drugs: Cyclophosphamide
Administered IV.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Dose Limiting Toxicities (DLTs) - Number of Participants with DLTs
Timepoint [1] 0 0
Baseline through Cycle 2 (28 Day Cycle)
Primary outcome [2] 0 0
Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) - ORR
Timepoint [2] 0 0
Baseline through Measured Progressive Disease (Estimated up to 5 Years)
Primary outcome [3] 0 0
Duration of Response (DoR) - DoR
Timepoint [3] 0 0
Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 5 Years)
Secondary outcome [1] 0 0
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668 - PK: AUC of LY3295668
Timepoint [1] 0 0
Cycle 1 Day 1 through Cycle 1 Day 15 (28 Day Cycles)
Secondary outcome [2] 0 0
PK: AUC of LY3295668 in Combination with Topotecan and Cyclophosphamide - PK: AUC of LY3295668 in Combination with topotecan and cyclophosphamide
Timepoint [2] 0 0
Cycle 1 Day 1 through Cycle 1 Day 15 (28 Day Cycles)
Secondary outcome [3] 0 0
Best Overall Response (BOR): Percentage of Participants with CR, PR, Stable Disease (SD), or Progressive Disease (PD) - BOR
Timepoint [3] 0 0
Baseline to Date of Objective Disease Progression (Estimated up to 5 Years)
Secondary outcome [4] 0 0
Progression-Free Survival (PFS) - PFS
Timepoint [4] 0 0
Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 5 Years)
Secondary outcome [5] 0 0
Overall Survival (OS) - OS
Timepoint [5] 0 0
Baseline to Date of Death from Any Cause (Estimated up to 6 Years)

Eligibility
Key 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.
Minimum age
2 Years
Maximum age
21 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
The Sydney Children's Hospitals Network - Westmead
Recruitment hospital [2] 0 0
Royal Childrens Hospital Melbourne - Parkville
Recruitment hospital [3] 0 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
3052 - Parkville
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Washington
Country [13] 0 0
Belgium
State/province [13] 0 0
Oost-Vlaanderen
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
France
State/province [15] 0 0
Lyon Cedex 08
Country [16] 0 0
France
State/province [16] 0 0
Paris CEDEX 05
Country [17] 0 0
France
State/province [17] 0 0
Toulouse Cedex 9
Country [18] 0 0
Germany
State/province [18] 0 0
Berlin
Country [19] 0 0
Germany
State/province [19] 0 0
Köln
Country [20] 0 0
Italy
State/province [20] 0 0
GE
Country [21] 0 0
Italy
State/province [21] 0 0
Lombardie
Country [22] 0 0
Italy
State/province [22] 0 0
Torino
Country [23] 0 0
Japan
State/province [23] 0 0
Tokyo
Country [24] 0 0
Spain
State/province [24] 0 0
Barcelona
Country [25] 0 0
Spain
State/province [25] 0 0
Madrid
Country [26] 0 0
Spain
State/province [26] 0 0
Valencia
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Cambridgeshire
Country [28] 0 0
United Kingdom
State/province [28] 0 0
London
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Leeds
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Liverpool

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
New Approaches to Neuroblastoma Therapy Consortium (NANT)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Innovative Therapies for Children with Cancer in Europe (ITCC)
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The reason for this study is to see if the study drug LY3295668 erbumine is safe in
participants with relapsed/refractory neuroblastoma.
Trial website
https://clinicaltrials.gov/show/NCT04106219
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
1-317-615-4559
Fax 0 0
Email 0 0
clinicaltrials.gov@lilly.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04106219