Metastatic Breast Cancer
Conditions
Keywords
aurora kinase A, kinase, aurora A, aurora kinase inhibitor, aurora kinase A inhibitor, kinase inhibitor, AURKA, AurA
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.
Interventions
Administered orally.
DRUGEndocrine therapy
Administered according to label instructions.
DRUGMidazolam
Administered orally.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Dose Reductions | Baseline through Cycle 1 (28 Day Cycle) | Number of Participants with Dose Reductions |
| Part II: Number of Participants with Dose Limiting Toxicities (DLTs) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| PK: AUC of Midazolam | Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) | PK: AUC of Midazolam |
| Progression-Free Survival (PFS) | 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 | 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 | Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) | PK: AUC of LY3295668 in Combination with Endocrine Therapy |
Countries
Belgium, United States
Outcome results
None listed