Small Cell Lung Cancer
Conditions
Keywords
aurora kinase A, kinase, aurora A, aurora kinase inhibitor, aurora kinase A inhibitor, kinase inhibitor, AURKA, AurA
Brief summary
The purpose of this study is to determine the recommended phase 2 dose of LY3295668 erbumine in participants with platinum-sensitive, extensive-stage small-cell lung cancer.
Interventions
oral capsules
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have histological or cytological evidence of a diagnosis of platinum sensitive small cell lung cancer that is extensive stage. * Have adequate organ function. * Have a performance status (PS) of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale. * Have discontinued previous treatments for cancer. * Are able to swallow capsules.
Exclusion criteria
* Currently enrolled in a clinical study. * Have a serious concomitant systemic disorder. * Have a symptomatic human immunodeficiency virus infection or symptomatic activated/reactivated hepatitis B or C. * Have a significant cardiac condition. * 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 |
| Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) | Baseline through Measured Progressive Disease (Estimated up to 20 Months) | ORR: Percentage of participants who achieve CR or PR |
| Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668 Erbumine | Predose Cyce 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) | PK: AUC of LY3295668 Erbumine |
| Duration of Response (DoR) | Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 20 Months) | DoR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best Overall Response (BOR): Percentage of Participants with CR, PR, Stable Disease (SD), or Progressive Disease (PD) | Baseline to Date of Objective Disease Progression (Estimated up to 20 Months) | BOR |
| Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and SD | Baseline through Measured Progressive Disease (Estimated up to 20 Months) | DCR |
| PK: Maximum Concentration (Cmax) of LY3295668 Erbumine | Predose Cyce 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) | PK: Cmax of LY3295668 Erbumine |
Countries
Belgium, France, Japan, South Korea, Spain, Turkey (Türkiye), United Kingdom, United States
Outcome results
None listed