This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of LY3295668 Erbumine in Participants With Extensive-stage Small-Cell Lung Cancer

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03898791
Recruitment Status : Completed
First Posted : April 2, 2019
Last Update Posted : August 5, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE April 1, 2019
First Posted Date  ICMJE April 2, 2019
Last Update Posted Date August 5, 2021
Actual Study Start Date  ICMJE July 16, 2019
Actual Primary Completion Date June 2, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2019)
  • Number of Participants with Dose Reductions [ Time Frame: Baseline through Cycle 1 (28 Day Cycle) ]
    Number of Participants with Dose Reductions
  • Objective 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 20 Months) ]
    ORR: Percentage of participants who achieve CR or PR
  • Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668 Erbumine [ Time Frame: Predose Cyce 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) ]
    PK: AUC of LY3295668 Erbumine
  • 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 20 Months) ]
    DoR
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2019)
  • PK: Maximum Concentration (Cmax) of LY3295668 Erbumine [ Time Frame: Predose Cyce 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) ]
    PK: Cmax of LY3295668 Erbumine
  • 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 20 Months) ]
    BOR
  • Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and SD [ Time Frame: Baseline through Measured Progressive Disease (Estimated up to 20 Months) ]
    DCR
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 Extensive-stage Small-Cell Lung Cancer
Official Title  ICMJE Phase 1b Study of LY3295668 Erbumine Monotherapy in Patients With Platinum-Sensitive, Extensive-Stage Small-Cell Lung Cancer
Brief Summary The purpose of this study is to determine the recommended phase 2 dose of LY3295668 erbumine in participants with platinum-sensitive, extensive-stage small-cell lung cancer.
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 Small Cell Lung Cancer
Intervention  ICMJE Drug: LY3295668 Erbumine
oral capsules
Study Arms  ICMJE
  • Experimental: LY3295668 Erbumine Cohort A
    LY3295668 erbumine administered orally.
    Intervention: Drug: LY3295668 Erbumine
  • Experimental: LY3295668 Erbumine Cohort B
    LY3295668 erbumine administered orally.
    Intervention: Drug: LY3295668 Erbumine
  • Experimental: LY3295668 Part JP
    LY3295668 erbumine administered orally.
    Intervention: Drug: LY3295668 Erbumine
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 Completed
Actual Enrollment  ICMJE
 (submitted: March 2, 2021)
48
Original Estimated Enrollment  ICMJE
 (submitted: April 1, 2019)
64
Actual Study Completion Date  ICMJE March 30, 2021
Actual Primary Completion Date June 2, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have histological or cytological evidence of a diagnosis of platinum sensitive small cell lung cancer that is extensive stage.
  • Have adequate organ function.
  • Have a performance status (PS) of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.
  • Have discontinued previous treatments for cancer.
  • Are able to swallow capsules.

Exclusion Criteria:

  • Currently enrolled in a clinical study.
  • Have a serious concomitant systemic disorder.
  • Have a symptomatic human immunodeficiency virus infection or symptomatic activated/reactivated hepatitis B or C.
  • Have a significant cardiac condition.
  • Have previously received an aurora kinase inhibitor.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   Japan,   Korea, Republic of,   Spain,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03898791
Other Study ID Numbers  ICMJE 17248
J1O-MC-JZHB ( Other Identifier: Eli Lilly and Company )
2018-003485-14 ( EudraCT Number )
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: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/
Current Responsible Party Eli Lilly and Company
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Eli Lilly and Company
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
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 July 2021

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