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

• ClinicalTrials.gov Identifier: NCT03955939
• Recruitment Status: Completed
• First Posted: May 20, 2019
• Last Update Posted: June 1, 2020
• Sponsor: Eli Lilly and Company
• Information provided by (Responsible Party): Eli Lilly and Company

Tracking Information

• First Submitted Date: May 17, 2019
• First Posted Date: May 20, 2019
• Last Update Posted Date: June 1, 2020
• Actual Study Start Date: August 2, 2019
• Actual Primary Completion Date: May 14, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 17, 2019)

• Number of Participants with Dose Reductions [ Time Frame: Baseline through Cycle 1 (28 Day Cycle) ]
  Number of Participants with Dose Reductions
• 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
• 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
• 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 17, 2019)

• 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
• Progression-Free Survival (PFS) [ Time Frame: Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 23 Months) ]
  PFS
• 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
• 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
• 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
• PK: AUC of Midazolam [ Time Frame: Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) ]
  PK: AUC of Midazolam
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of LY3295668 Erbumine in Participants With Breast Cancer That Has Spread to Other Parts of the Body
• 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
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Metastatic Breast Cancer

Intervention

• Drug: LY3295668 Erbumine
  Administered orally.
• Drug: Endocrine therapy
  Administered according to label instructions.
• Drug: Midazolam
  Administered orally.

Study Arms

• Experimental: LY3295668 Erbumine Part A

  LY3295668 erbumine administered orally (Part I).

  Approximately the first 10 participants enrolled in this arm will be administered midazolam.

  Interventions:

  • Drug: LY3295668 Erbumine
  • Drug: Midazolam
• Experimental: LY3295668 Erbumine Part B

  LY3295668 erbumine administered orally (Part I).

  Approximately the first 10 participants enrolled in this arm will be administered midazolam.

  Interventions:

  • Drug: LY3295668 Erbumine
  • Drug: Midazolam
• Experimental: LY3295668 Erbumine + Endocrine Therapy Cohort 1
  LY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part II).
  Interventions:

  • Drug: LY3295668 Erbumine
  • Drug: Endocrine therapy
• Experimental: LY3295668 Erbumine + Endocrine Therapy Continuation Part C
  LY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part I).
  Interventions:

  • Drug: LY3295668 Erbumine
  • Drug: Endocrine therapy
• Experimental: LY3295668 Erbumine + Endocrine Therapy Switch Part D
  LY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part I).
  Interventions:

  • Drug: LY3295668 Erbumine
  • Drug: Endocrine therapy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 29, 2020): 5
• Original Estimated Enrollment (submitted: May 17, 2019): 100
• Actual Study Completion Date: May 14, 2020
• Actual Primary Completion Date: May 14, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, United States
• Removed Location Countries: France, Italy, Korea, Republic of, Spain

Administrative Information

• NCT Number: NCT03955939
• Other Study ID Numbers: 17249; J1O-MC-JZHC ( Other Identifier: Eli Lilly and Company ); 2018-004183-61 ( EudraCT Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Eli Lilly and Company
• Original Responsible Party: Same as current
• Current Study Sponsor: Eli Lilly and Company
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST); Eli Lilly and Company

• PRS Account: Eli Lilly and Company
• Verification Date: May 2020