Clinical Trials /

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

NCT03898791

Description:

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.

Related Conditions:
  • Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of LY3295668 Erbumine in Participants With Extensive-stage Small-Cell Lung Cancer
  • Official Title: Phase 1b Study of LY3295668 Erbumine Monotherapy in Patients With Platinum-Sensitive, Extensive-Stage Small-Cell Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: 17248
  • SECONDARY ID: J1O-MC-JZHB
  • SECONDARY ID: 2018-003485-14
  • NCT ID: NCT03898791

Conditions

  • Small Cell Lung Cancer

Interventions

DrugSynonymsArms
LY3295668 ErbumineLY3295668 Erbumine Cohort A

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
LY3295668 Erbumine Cohort AExperimentalLY3295668 erbumine administered orally.
  • LY3295668 Erbumine
LY3295668 Erbumine Cohort BExperimentalLY3295668 erbumine administered orally.
  • LY3295668 Erbumine
LY3295668 Part JPExperimentalLY3295668 erbumine administered orally.
  • LY3295668 Erbumine

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants with Dose Reductions
Time Frame:Baseline through Cycle 1 (28 Day Cycle)
Safety Issue:
Description:Number of Participants with Dose Reductions

Secondary Outcome Measures

Measure:PK: Maximum Concentration (Cmax) of LY3295668 Erbumine
Time Frame:Predose Cyce 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
Safety Issue:
Description:PK: Cmax of LY3295668 Erbumine
Measure: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)
Safety Issue:
Description:BOR
Measure: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)
Safety Issue:
Description:DCR

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Eli Lilly and Company

Trial Keywords

  • aurora kinase A
  • kinase
  • aurora A
  • aurora kinase inhibitor
  • aurora kinase A inhibitor
  • kinase inhibitor
  • AURKA
  • AurA

Last Updated

November 18, 2019