Description:
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.
Title
- Brief Title: A Study of LY3295668 Erbumine in Participants With Extensive-stage Small-Cell Lung Cancer
- Official Title: Phase 1b Study of LY3295668 Erbumine Monotherapy in Patients With Platinum-Sensitive, Extensive-Stage Small-Cell Lung Cancer
Clinical Trial IDs
- ORG STUDY ID:
17248
- SECONDARY ID:
J1O-MC-JZHB
- SECONDARY ID:
2018-003485-14
- NCT ID:
NCT03898791
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| LY3295668 Erbumine | | LY3295668 Erbumine Cohort A |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| LY3295668 Erbumine Cohort A | Experimental | LY3295668 erbumine administered orally. | |
| LY3295668 Erbumine Cohort B | Experimental | LY3295668 erbumine administered orally. | |
| LY3295668 Part JP | Experimental | LY3295668 erbumine administered orally. | |
Eligibility Criteria
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.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| 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: | PK: Maximum Concentration (Cmax) of LY3295668 Erbumine |
| Time Frame: | Predose Cyce 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) |
| Safety Issue: | |
| Description: | PK: Cmax of LY3295668 Erbumine |
| Measure: | Best Overall Response (BOR): Percentage of Participants with CR, PR, Stable Disease (SD), or Progressive Disease (PD) |
| Time Frame: | Baseline to Date of Objective Disease Progression (Estimated up to 20 Months) |
| Safety Issue: | |
| Description: | BOR |
| Measure: | Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and SD |
| Time Frame: | Baseline through Measured Progressive Disease (Estimated up to 20 Months) |
| Safety Issue: | |
| Description: | DCR |
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
August 5, 2021
