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

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: Completed
• Conditions: Metastatic Breast Cancer
• Intervention / Treatment: Drug: LY3295668 Erbumine; Drug: Midazolam; Drug: Endocrine therapy

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 1

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Number of Participants with Dose Reductions	Number of Participants with Dose Reductions	Baseline through Cycle 1 (28 Day Cycle)
Part II: Number of Participants with Dose Limiting Toxicities (DLTs)	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)	ORR	Baseline through Measured Progressive Disease (Estimated up to 23 Months)
Duration of Response (DoR)	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

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	CBR	Baseline through Disease Progression or Death Due to Any Cause (Estimated up to 23 Months)
Progression-Free Survival (PFS)	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	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	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	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	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	PK: AUC of Midazolam in Combination with LY3295668	Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2019
• Primary Completion (Actual): May 14, 2020
• Study Completion (Actual): May 14, 2020

Study Registration Dates

• First Submitted: May 17, 2019
• First Submitted That Met QC Criteria: May 17, 2019
• First Posted (Actual): May 20, 2019

Study Record Updates

• Last Update Posted (Actual): June 1, 2020
• Last Update Submitted That Met QC Criteria: May 29, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: aurora kinase A; kinase; aurora A; aurora kinase inhibitor; aurora kinase A inhibitor; kinase inhibitor; AURKA; AurA
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID 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