Clinical Trials /

A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer

NCT04188548

Description:

The reason for this study is to see if the study drug LY3484356 alone or in combination with abemaciclib is safe and effective in participants with advanced or metastatic breast cancer.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer
  • Official Title: A Phase 1a/1b Study of LY3484356 Administered as Monotherapy and in Combination With Abemaciclib to Patients With ER+, HER2- Locally Advanced or Metastatic Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: 17502
  • SECONDARY ID: J2J-MC-JZLA
  • SECONDARY ID: 2019-003581-41
  • NCT ID: NCT04188548

Conditions

  • Breast Cancer
  • Advanced Breast Cancer
  • Metastatic Breast Cancer

Interventions

DrugSynonymsArms
LY3484356Dose Escalation LY3484356
AbemaciclibLY2835219Dose Escalation LY3484356 + Abemaciclib

Purpose

The reason for this study is to see if the study drug LY3484356 alone or in combination with abemaciclib is safe and effective in participants with advanced or metastatic breast cancer.

Trial Arms

NameTypeDescriptionInterventions
Dose Escalation LY3484356ExperimentalLY3484356 given orally.
  • LY3484356
Dose Escalation LY3484356 + AbemaciclibExperimentalLY3484356 and abemaciclib given orally.
  • LY3484356
  • Abemaciclib
Dose Expansion LY3484356ExperimentalLY3484356 given orally.
  • LY3484356
Dose Expansion LY3484356 + AbemaciclibExperimentalLY3484356 and abemaciclib given orally.
  • LY3484356
  • Abemaciclib

Eligibility Criteria

        Inclusion Criteria:

          -  Participants must have estrogen receptor positive (ER+), human epidermal growth factor
             receptor 2 negative (HER2-) breast cancer that may have spread to other part(s) of the
             body and has had at least 1 line of standard therapy

          -  Participants with measurable disease must be willing to have new tumor tissue biopsies
             (doctor removes a small amount of tissue) during the study if it does not cause undue
             risks to health

          -  Participants must be willing to use highly effective birth control

          -  Participants must have adequate organ function

          -  Participants must be able to swallow capsules

        Exclusion Criteria:

          -  Participants must not have certain infections such as hepatitis or tuberculosis or HIV
             that are not well controlled

          -  Participants must not have another serious medical condition

          -  Participants must not have cancer of the central nervous system that is not stable

          -  Participants must not be pregnant or breastfeeding
      
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 Limiting Toxicities (DLTs)
Time Frame:Baseline through Cycle 1 (28 Day Cycle)
Safety Issue:
Description:Number of Participants with DLTs

Secondary Outcome Measures

Measure:Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3484356
Time Frame:Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (28 Day Cycles)
Safety Issue:
Description:PK: AUC of LY3484356
Measure:PK: Maximum Concentration (Cmax) of LY3484356
Time Frame:Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (28 Day Cycles)
Safety Issue:
Description:PK: Cmax of LY3484356
Measure:PK: AUC of LY3484356 in Combination with Abemaciclib
Time Frame:Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (28 Day Cycles)
Safety Issue:
Description:PK: AUC of LY3484356 in Combination with Abemaciclib
Measure:PK: Cmax of LY3484356 in Combination with Abemaciclib
Time Frame:Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (28 Day Cycles)
Safety Issue:
Description:PK: Cmax of LY3484356 in Combination with Abemaciclib
Measure:Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR)
Time Frame:Baseline through Disease Progression or Death (Estimated up to 42 Months)
Safety Issue:
Description:ORR: Percentage of Participants with CR or PR
Measure:Duration of Response (DoR)
Time Frame:Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Estimated up to 42 Months)
Safety Issue:
Description:DoR
Measure:Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and Stable Disease
Time Frame:Baseline through Measured Progressive Disease (Estimated up to 42 Months)
Safety Issue:
Description:DCR: Percentage of Participants with a Best Overall Response of CR, PR, and Stable Disease
Measure:Progression Free Survival (PFS)
Time Frame:Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 42 Months)
Safety Issue:
Description:PFS

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Eli Lilly and Company

Last Updated

December 4, 2019