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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04106219
Ethics application status
Date submitted
25/09/2019
Date registered
26/09/2019

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)
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)
Timepoint [2] 0 0
Baseline through Measured Progressive Disease (Estimated up to 5 Years)
Primary outcome [3] 0 0
Duration of Response (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
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
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)
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)
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)
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
Sex
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/06/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2025
Actual
Sample size
Target
71
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Perth Children's Hospital - Perth
Recruitment postcode(s) [1] 0 0
6009 - Perth
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
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Belgium
State/province [8] 0 0
Oost-Vlaanderen
Country [9] 0 0
France
State/province [9] 0 0
Rhône-Alpes
Country [10] 0 0
France
State/province [10] 0 0
Paris CEDEX 05
Country [11] 0 0
Germany
State/province [11] 0 0
Köln
Country [12] 0 0
Italy
State/province [12] 0 0
Lombardie
Country [13] 0 0
Japan
State/province [13] 0 0
Tokyo
Country [14] 0 0
Spain
State/province [14] 0 0
Barcelona [Barcelona]
Country [15] 0 0
Spain
State/province [15] 0 0
Madrid
Country [16] 0 0
United Kingdom
State/province [16] 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
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04106219