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Metastatic Breast CancerPhase 1NCT03955939

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

A Phase 1 study testing LY3295668 Erbumine, Endocrine therapy and Midazolam in people with Metastatic Breast Cancer, run by Eli Lilly and Company at 7 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
LY3295668 Erbumine, Endocrine therapy and Midazolam
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
7 sitesin 2 countries
Study dates
2 Aug 2019to 14 May 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

Belgium4 sites

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

    Leuven, 3000

Other trials in Belgium

United States3 sites

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • City of Hope National Medical Center

    Duarte, California, 91010-0269

  • South Texas Accelerated Research Therapeutics, LLC

    San Antonio, Texas, 78229-3307

Other trials in United States

About this study

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

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.

Being tested
LY3295668 Erbumine, Endocrine therapy, Midazolam
Keywords
aurora kinase A, kinase, aurora A, aurora kinase inhibitor, aurora kinase A inhibitor, kinase inhibitor, AURKA, AurA
Medical subject headings
Breast Neoplasms, Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY3295668 ErbumineDrug

    Administered orally.

  • Endocrine therapyDrug

    Administered according to label instructions.

  • MidazolamDrug

    Administered orally.

Study groups in NCT03955939
Study groupRoleWhat they receive
LY3295668 Erbumine Part AExperimentalLY3295668 erbumine administered orally (Part I). Approximately the first 10 participants enrolled in this arm will be administered midazolam.
Receives: Drug: LY3295668 Erbumine; Drug: Midazolam
LY3295668 Erbumine Part BExperimentalLY3295668 erbumine administered orally (Part I). Approximately the first 10 participants enrolled in this arm will be administered midazolam.
Receives: Drug: LY3295668 Erbumine; Drug: Midazolam
LY3295668 Erbumine + Endocrine Therapy Cohort 1ExperimentalLY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part II).
Receives: Drug: LY3295668 Erbumine; Drug: Endocrine therapy
LY3295668 Erbumine + Endocrine Therapy Continuation Part CExperimentalLY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part I).
Receives: Drug: LY3295668 Erbumine; Drug: Endocrine therapy
LY3295668 Erbumine + Endocrine Therapy Switch Part DExperimentalLY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part I).
Receives: Drug: LY3295668 Erbumine; Drug: Endocrine therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Dose Reductions

    Number of Participants with Dose Reductions

    Measured: Baseline through Cycle 1 (28 Day Cycle)

  2. Part II: Number of Participants with Dose Limiting Toxicities (DLTs)

    Part II: Number of Participants with DLTs

    Measured: Baseline through Cycle 1 (28 Day Cycle)

  3. Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)

    ORR

    Measured: Baseline through Measured Progressive Disease (Estimated up to 23 Months)

  4. Duration of Response (DoR)

    DoR

    Measured: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 23 Months)

Secondary outcomes (7)

  1. Clinical Benefit Rate (CBR): Percentage of Participants Who Achieve CR, PR or SD With a Duration of At Least 6 Months

    CBR

    Measured: Baseline through Disease Progression or Death Due to Any Cause (Estimated up to 23 Months)

  2. Progression-Free Survival (PFS)

    PFS

    Measured: Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 23 Months)

  3. Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668

    PK: AUC of LY3295668

    Measured: Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)

  4. PK: AUC of LY3295668 in Combination with Endocrine Therapy

    PK: AUC of LY3295668 in Combination with Endocrine Therapy

    Measured: Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)

  5. PK: AUC of Endocrine Therapy in Combination with LY3295668

    PK: AUC of Endocrine Therapy in Combination with LY3295668

    Measured: Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)

  6. PK: AUC of Midazolam

    PK: AUC of Midazolam

    Measured: Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)

  7. PK: AUC of Midazolam in Combination with LY3295668

    PK: AUC of Midazolam in Combination with LY3295668

    Measured: Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2019
  2. Study start2 Aug 2019
  3. Primary completion14 May 2020
  4. Study completion14 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03955939
Sponsor's protocol ID
17249
Other IDs
J1O-MC-JZHC, 2018-004183-61, 2018
Status last verified
May 2020
First submitted
17 May 2019
Last updated
1 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY3295668 Erbumine, Endocrine therapy and Midazolam in people with Metastatic Breast Cancer, run by Eli Lilly and Company at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Belgium, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Dose Reductions (time frame: Baseline through Cycle 1 (28 Day Cycle)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03955939.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2020; AzTrials last refreshed its copy on 8 Nov 2026.

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