Clinical Trials /

A Study of LY3295668 Erbumine in Participants With Breast Cancer That Has Spread to Other Parts of the Body

NCT03955939

Description:

The reason for this study is to determine the recommended phase 2 dose of the study drug LY3295668 erbumine in participants with breast cancer that has spread to other parts of the body.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of LY3295668 Erbumine in Participants With Breast Cancer That Has Spread to Other Parts of the Body
  • Official Title: A Phase 1b Study of Aurora A Kinase Inhibitor LY3295668 Erbumine in Monotherapy and Combination Therapy in Patients With Metastatic Breast Cancer Post CDK4/6 Inhibitor and Endocrine Therapy

Clinical Trial IDs

  • ORG STUDY ID: 17249
  • SECONDARY ID: J1O-MC-JZHC
  • SECONDARY ID: 2018-004183-61
  • NCT ID: NCT03955939

Conditions

  • Metastatic Breast Cancer

Interventions

DrugSynonymsArms
LY3295668 ErbumineLY3295668 Erbumine Part A
Endocrine therapyLY3295668 Erbumine + Endocrine Therapy Cohort 1
MidazolamLY3295668 Erbumine Part A

Purpose

The reason for this study is to determine the recommended phase 2 dose of the study drug LY3295668 erbumine in participants with breast cancer that has spread to other parts of the body.

Trial Arms

NameTypeDescriptionInterventions
LY3295668 Erbumine Part AExperimentalLY3295668 erbumine administered orally (Part I). Approximately the first 10 participants enrolled in this arm will be administered midazolam.
  • LY3295668 Erbumine
  • Midazolam
LY3295668 Erbumine Part BExperimentalLY3295668 erbumine administered orally (Part I). Approximately the first 10 participants enrolled in this arm will be administered midazolam.
  • LY3295668 Erbumine
  • Midazolam
LY3295668 Erbumine + Endocrine Therapy Cohort 1ExperimentalLY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part II).
  • LY3295668 Erbumine
  • Endocrine therapy
LY3295668 Erbumine + Endocrine Therapy Continuation Part CExperimentalLY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part I).
  • LY3295668 Erbumine
  • Endocrine therapy
LY3295668 Erbumine + Endocrine Therapy Switch Part DExperimentalLY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part I).
  • LY3295668 Erbumine
  • Endocrine therapy

Eligibility Criteria

        Inclusion Criteria:

          -  Participant must have hormone receptor positive and HER2 negative metastatic breast
             cancer

          -  Participant must have progressed on at least 1 line of endocrine therapy and 1 cyclin
             dependent kinase (CDK)4/6 inhibitor

          -  Participant must be able and willing to undergo mandatory tumor biopsy

          -  Participant must have normal organ function

          -  Participant must be able to swallow capsules

        Exclusion Criteria:

          -  Participant must not have had prior chemotherapy for mBC. Chemotherapy in the
             adjuvant/neoadjuvant setting is permitted

          -  Participant must not be currently enrolled in a clinical study

          -  Participant must not have another serious medical condition

          -  Participant must not have previously received an aurora kinase inhibitor
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
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:Clinical Benefit Rate (CBR): Percentage of Participants Who Achieve CR, PR or SD With a Duration of At Least 6 Months
Time Frame:Baseline through Disease Progression or Death Due to Any Cause (Estimated up to 23 Months)
Safety Issue:
Description:CBR
Measure:Progression-Free Survival (PFS)
Time Frame:Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 23 Months)
Safety Issue:
Description:PFS
Measure:Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668
Time Frame:Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
Safety Issue:
Description:PK: AUC of LY3295668
Measure:PK: AUC of LY3295668 in Combination with Endocrine Therapy
Time Frame:Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
Safety Issue:
Description:PK: AUC of LY3295668 in Combination with Endocrine Therapy
Measure:PK: AUC of Endocrine Therapy in Combination with LY3295668
Time Frame:Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
Safety Issue:
Description:PK: AUC of Endocrine Therapy in Combination with LY3295668
Measure:PK: AUC of Midazolam
Time Frame:Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
Safety Issue:
Description:PK: AUC of Midazolam
Measure:PK: AUC of Midazolam in Combination with LY3295668
Time Frame:Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
Safety Issue:
Description:PK: AUC of Midazolam in Combination with LY3295668

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet 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