Description:
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.
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
17249
- SECONDARY ID:
J1O-MC-JZHC
- SECONDARY ID:
2018-004183-61
- NCT ID:
NCT03955939
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| LY3295668 Erbumine | | LY3295668 Erbumine + Endocrine Therapy Cohort 1 |
| Endocrine therapy | | LY3295668 Erbumine + Endocrine Therapy Cohort 1 |
| Midazolam | | LY3295668 Erbumine Part A |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| LY3295668 Erbumine Part A | Experimental | LY3295668 erbumine administered orally (Part I).
Approximately the first 10 participants enrolled in this arm will be administered midazolam. | - LY3295668 Erbumine
- Midazolam
|
| LY3295668 Erbumine Part B | Experimental | LY3295668 erbumine administered orally (Part I).
Approximately the first 10 participants enrolled in this arm will be administered midazolam. | - LY3295668 Erbumine
- Midazolam
|
| LY3295668 Erbumine + Endocrine Therapy Cohort 1 | Experimental | LY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part II). | - LY3295668 Erbumine
- Endocrine therapy
|
| LY3295668 Erbumine + Endocrine Therapy Continuation Part C | Experimental | LY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part I). | - LY3295668 Erbumine
- Endocrine therapy
|
| LY3295668 Erbumine + Endocrine Therapy Switch Part D | Experimental | LY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part I). | - LY3295668 Erbumine
- Endocrine therapy
|
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | Female |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Number of Participants with Dose Reductions |
| Time Frame: | Baseline through Cycle 1 (28 Day Cycle) |
| Safety Issue: | |
| Description: | Number of Participants with Dose Reductions |
Secondary Outcome Measures
| Measure: | 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) |
| Safety Issue: | |
| Description: | CBR |
| Measure: | Progression-Free Survival (PFS) |
| Time Frame: | Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 23 Months) |
| Safety Issue: | |
| Description: | PFS |
| Measure: | 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) |
| Safety Issue: | |
| Description: | PK: AUC of LY3295668 |
| Measure: | PK: AUC of LY3295668 in Combination with Endocrine Therapy |
| Time Frame: | Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) |
| Safety Issue: | |
| Description: | PK: AUC of LY3295668 in Combination with Endocrine Therapy |
| Measure: | PK: AUC of Endocrine Therapy in Combination with LY3295668 |
| Time Frame: | Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) |
| Safety Issue: | |
| Description: | PK: AUC of Endocrine Therapy in Combination with LY3295668 |
| Measure: | PK: AUC of Midazolam |
| Time Frame: | Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) |
| Safety Issue: | |
| Description: | PK: AUC of Midazolam |
| Measure: | PK: AUC of Midazolam in Combination with LY3295668 |
| Time Frame: | Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) |
| Safety Issue: | |
| Description: | PK: AUC of Midazolam in Combination with LY3295668 |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Completed |
| Lead Sponsor: | Eli Lilly and Company |
Trial Keywords
- aurora kinase A
- kinase
- aurora A
- aurora kinase inhibitor
- aurora kinase A inhibitor
- kinase inhibitor
- AURKA
- AurA
Last Updated
June 1, 2020
