A Study of LY3295668 Erbumine in Participants With Breast Cancer That Has Spread to Other Parts of the Body
Phase 1
Completed
- Conditions
- Metastatic Breast Cancer
- Interventions
- Registration Number
- NCT03955939
- Lead Sponsor
- Eli Lilly and Company
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 5
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LY3295668 Erbumine Part A LY3295668 Erbumine LY3295668 erbumine administered orally (Part I). Approximately the first 10 participants enrolled in this arm will be administered midazolam. LY3295668 Erbumine Part B LY3295668 Erbumine LY3295668 erbumine administered orally (Part I). Approximately the first 10 participants enrolled in this arm will be administered midazolam. LY3295668 Erbumine + Endocrine Therapy Cohort 1 LY3295668 Erbumine LY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part II). LY3295668 Erbumine + Endocrine Therapy Cohort 1 Endocrine therapy LY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part II). LY3295668 Erbumine + Endocrine Therapy Continuation Part C LY3295668 Erbumine LY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part I). LY3295668 Erbumine + Endocrine Therapy Continuation Part C Endocrine therapy LY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part I). LY3295668 Erbumine + Endocrine Therapy Switch Part D LY3295668 Erbumine LY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part I). LY3295668 Erbumine + Endocrine Therapy Switch Part D Endocrine therapy LY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part I). LY3295668 Erbumine Part A Midazolam LY3295668 erbumine administered orally (Part I). Approximately the first 10 participants enrolled in this arm will be administered midazolam. LY3295668 Erbumine Part B Midazolam LY3295668 erbumine administered orally (Part I). Approximately the first 10 participants enrolled in this arm will be administered midazolam.
- Primary Outcome Measures
Name Time Method Part II: Number of Participants with Dose Limiting Toxicities (DLTs) Baseline through Cycle 1 (28 Day Cycle) Part II: Number of Participants with DLTs
Number of Participants with Dose Reductions Baseline through Cycle 1 (28 Day Cycle) Number of Participants with Dose Reductions
Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) Baseline through Measured Progressive Disease (Estimated up to 23 Months) ORR
Duration of Response (DoR) Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 23 Months) DoR
- Secondary Outcome Measures
Name Time Method Progression-Free Survival (PFS) Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 23 Months) PFS
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 LY3295668 in Combination with Endocrine Therapy
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 Endocrine Therapy in Combination with LY3295668
PK: AUC of Midazolam 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 Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) PK: AUC of Midazolam in Combination with LY3295668
Clinical Benefit Rate (CBR): Percentage of Participants Who Achieve CR, PR or SD With a Duration of At Least 6 Months Baseline through Disease Progression or Death Due to Any Cause (Estimated up to 23 Months) CBR
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668 Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) PK: AUC of LY3295668
Trial Locations
- Locations (7)
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, United States
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
🇧🇪Leuven, Belgium
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium