Clinical trial NCT04106219: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Neuroblastoma
Keywords: aurora kinase A
kinase
aurora A
aurora kinase inhibitor
aurora kinase A inhibitor
kinase inhibitor
AURKA
AurA
pediatric neuroblastoma
children
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: New Approaches to Neuroblastoma Therapy Consortium (NANT)
name: Innovative Therapies for Children with Cancer in Europe (ITCC)
First posted: 2019-09-26
Enrollment: 71
Sex: ALL
Minimum age (years): 2
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Number of Participants with Dose Limiting Toxicities (DLTs)
timeFrame: Baseline through Cycle 2 (28 Day Cycle)
measure: Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
timeFrame: Baseline through Measured Progressive Disease (Estimated up to 5 Years)
measure: Duration of Response (DoR)
timeFrame: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 5 Years)
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668
timeFrame: Cycle 1 Day 1 through Cycle 1 Day 15 (28 Day Cycles)
measure: PK: AUC of LY3295668 in Combination with Topotecan and Cyclophosphamide
timeFrame: Cycle 1 Day 1 through Cycle 1 Day 15 (28 Day Cycles)
measure: Best Overall Response (BOR): Percentage of Participants with CR, PR, Stable Disease (SD), or Progressive Disease (PD)
timeFrame: Baseline to Date of Objective Disease Progression (Estimated up to 5 Years)
measure: Progression-Free Survival (PFS)
timeFrame: Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 5 Years)
measure: Overall Survival (OS)
timeFrame: Baseline to Date of Death from Any Cause (Estimated up to 6 Years)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Medical Center at Mission Bay
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Chicago
country: United States
facility: University of Chicago - Comer Children's Hospital
state: Illinois
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Cincinnati
country: United States
facility: Cincinnati Childrens Hospital Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Houston
country: United States
facility: Texas Childrens Hospital
state: Texas
city: Perth
country: Australia
facility: Perth Children's Hospital
state: Western Australia
city: Gent
country: Belgium
facility: UZ Gent
state: Oost-Vlaanderen
city: Lyon
country: France
facility: Centre Leon Berard
state: Rhône-Alpes
city: Paris CEDEX 05
country: France
facility: Institut Curie
city: Köln
country: Germany
facility: Universitätsklinikum Köln
city: Milano
country: Italy
facility: Istituto Nazionale dei Tumori
state: Lombardie
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
state: Barcelona [Barcelona]
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Niño Jesús
city: Liverpool
country: United Kingdom
facility: Alder Hey Children's Hospital
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: