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

Metastatic Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03955939
• Other study ID #: 17249
• Secondary ID: J1O-MC-JZHC2018-
• Status: Completed
• Phase: Phase 1
• Start date: August 2, 2019
• Est. completion date: May 14, 2020

Study information

• Verified date: May 2020
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: May 14, 2020
• Est. primary completion date: May 14, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

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

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Brussels
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg	Leuven
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	City of Hope National Medical Center	Duarte	California
United States	South Texas Accelerated Research Therapeutics, LLC	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Dose Reductions	Number of Participants with Dose Reductions	Baseline through Cycle 1 (28 Day Cycle)
Primary	Part II: Number of Participants with Dose Limiting Toxicities (DLTs)	Part II: Number of Participants with DLTs	Baseline through Cycle 1 (28 Day Cycle)
Primary	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)
Primary	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	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)
Secondary	Progression-Free Survival (PFS)	PFS	Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 23 Months)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	PK: AUC of Midazolam	PK: AUC of Midazolam	Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
Secondary	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)

External Links

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