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

May 29, 2020 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques universitaires Saint-Luc
      • Edegem, Belgium, 2650
        • Universitair Ziekenhuis Antwerpen
      • Gent, Belgium, 9000
        • Universitair Ziekenhuis Gent
      • Leuven, Belgium, 3000
        • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
  • United States
    • California
      • Duarte, California, United States, 91010-0269
        • City of Hope National Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute
    • Texas
      • San Antonio, Texas, United States, 78229-3307
        • South Texas Accelerated Research Therapeutics, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: LY3295668 Erbumine Part A

LY3295668 erbumine administered orally (Part I).

Approximately the first 10 participants enrolled in this arm will be administered midazolam.
Drug: LY3295668 Erbumine
Administered orally.
Drug: Midazolam
Administered orally.
Experimental: LY3295668 Erbumine Part B

LY3295668 erbumine administered orally (Part I).

Approximately the first 10 participants enrolled in this arm will be administered midazolam.
Drug: LY3295668 Erbumine
Administered orally.
Drug: Midazolam
Administered orally.
Experimental: LY3295668 Erbumine + Endocrine Therapy Cohort 1
LY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part II).
Drug: LY3295668 Erbumine
Administered orally.
Drug: Endocrine therapy
Administered according to label instructions.
Experimental: LY3295668 Erbumine + Endocrine Therapy Continuation Part C
LY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part I).
Drug: LY3295668 Erbumine
Administered orally.
Drug: Endocrine therapy
Administered according to label instructions.
Experimental: LY3295668 Erbumine + Endocrine Therapy Switch Part D
LY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part I).
Drug: LY3295668 Erbumine
Administered orally.
Drug: Endocrine therapy
Administered according to label instructions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Dose Reductions
Time Frame: Baseline through Cycle 1 (28 Day Cycle)
Number of Participants with Dose Reductions
Baseline through Cycle 1 (28 Day Cycle)
Part II: Number of Participants with Dose Limiting Toxicities (DLTs)
Time Frame: Baseline through Cycle 1 (28 Day Cycle)
Part II: Number of Participants with DLTs
Baseline through Cycle 1 (28 Day Cycle)
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 23 Months)
ORR
Baseline through Measured Progressive Disease (Estimated up to 23 Months)
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 23 Months)
DoR
Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 23 Months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
CBR
Baseline through Disease Progression or Death Due to Any Cause (Estimated up to 23 Months)
Progression-Free Survival (PFS)
Time Frame: Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 23 Months)
PFS
Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 23 Months)
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)
PK: AUC of LY3295668
Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
PK: AUC of LY3295668 in Combination with Endocrine Therapy
Time Frame: Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
PK: AUC of LY3295668 in Combination with Endocrine Therapy
Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
PK: AUC of Endocrine Therapy in Combination with LY3295668
Time Frame: Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
PK: AUC of Endocrine Therapy in Combination with LY3295668
Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
PK: AUC of Midazolam
Time Frame: Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
PK: AUC of Midazolam
Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
PK: AUC of Midazolam in Combination with LY3295668
Time Frame: Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
PK: AUC of Midazolam in Combination with LY3295668
Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 2, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 14, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 14, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17249
  • J1O-MC-JZHC (Other Identifier: Eli Lilly and Company)
  • 2018-004183-61 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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