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Completed

NCT Number: NCT03955939

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

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.

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Key information

Conditions

Metastatic Breast Cancer Brain Diseases Breast Diseases Breast Neoplasms Central Nervous System Diseases Epilepsy Neoplasms Neoplasms by Site Nervous System Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Cliniques Universitaires Saint-Luc, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3295668 Erbumine

Drug

Administered orally.

endocrine therapy

Drug

Administered according to label instructions.

midazolam

Drug

Administered orally.

Primary outcomes

  1. Number of Participants with Dose Reductions

    Time frame: Baseline through Cycle 1 (28 Day Cycle)

    Number of Participants with Dose Reductions

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. 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

  2. Progression-Free Survival (PFS)

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

    PFS

  3. 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

  4. 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

  5. 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

  6. PK: AUC of Midazolam

    Time frame: Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)

    PK: AUC of Midazolam

  7. 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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 20, 2019
Registry last updated
Jun 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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