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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04106219
Recruitment Status : Recruiting
First Posted : September 26, 2019
Last Update Posted : April 8, 2021
Sponsor:
Collaborators:
New Approaches to Neuroblastoma Therapy Consortium (NANT)
Innovative Therapies for Children with Cancer in Europe (ITCC)
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE September 25, 2019
First Posted Date  ICMJE September 26, 2019
Last Update Posted Date April 8, 2021
Actual Study Start Date  ICMJE June 11, 2020
Estimated Primary Completion Date April 17, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2019)
  • Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: 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) [ Time Frame: Baseline through Measured Progressive Disease (Estimated up to 5 Years) ]
    ORR
  • Duration of Response (DoR) [ Time Frame: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 5 Years) ]
    DoR
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2019)
  • Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: Baseline to Date of Objective Disease Progression (Estimated up to 5 Years) ]
    BOR
  • Progression-Free Survival (PFS) [ Time Frame: Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 5 Years) ]
    PFS
  • Overall Survival (OS) [ Time Frame: Baseline to Date of Death from Any Cause (Estimated up to 6 Years) ]
    OS
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of LY3295668 Erbumine in Participants With Relapsed/Refractory Neuroblastoma
Official Title  ICMJE A Phase 1 Study of Aurora Kinase A Inhibitor LY3295668 Erbumine as a Single Agent and in Combination in Patients With Relapsed/Refractory Neuroblastoma
Brief Summary The reason for this study is to see if the study drug LY3295668 erbumine is safe in participants with relapsed/refractory neuroblastoma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neuroblastoma
Intervention  ICMJE
  • Drug: LY3295668 Erbumine
    Administered orally.
  • Drug: Topotecan
    Administered IV.
  • Drug: Cyclophosphamide
    Administered IV.
Study Arms  ICMJE
  • Experimental: LY3295668 Erbumine Escalation
    LY3295668 Erbumine given orally.
    Intervention: Drug: LY3295668 Erbumine
  • Experimental: LY3295668 Erbumine + Topotecan + Cyclophosphamide Escalation
    LY3295668 Erbumine given orally and topotecan and cyclophosphamide given intravenously (IV).
    Interventions:
    • Drug: LY3295668 Erbumine
    • Drug: Topotecan
    • Drug: Cyclophosphamide
  • Experimental: LY3295668 Erbumine Expansion
    LY3295668 Erbumine given orally.
    Intervention: Drug: LY3295668 Erbumine
  • Experimental: LY3295668 Erbumine + Topotecan + Cyclophosphamide Expansion
    LY3295668 Erbumine given orally and topotecan and cyclophosphamide given IV.
    Interventions:
    • Drug: LY3295668 Erbumine
    • Drug: Topotecan
    • Drug: Cyclophosphamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 25, 2019)
71
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 18, 2025
Estimated Primary Completion Date April 17, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 clinicaltrials.gov@lilly.com
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   France,   Germany,   Italy,   Japan,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04106219
Other Study ID Numbers  ICMJE 17295
J1O-MC-JZHD ( Other Identifier: Eli Lilly and Company )
2019-001042-18 ( EudraCT Number )
2019-01 ( Other Identifier: NANT )
ITCC-085 ( Other Identifier: ITCC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE
  • New Approaches to Neuroblastoma Therapy Consortium (NANT)
  • Innovative Therapies for Children with Cancer in Europe (ITCC)
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date April 1, 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP