A Study of LY3295668 Erbumine in Participants With Extensive-stage Small-Cell Lung Cancer

Phase 1

Completed

• Conditions: Small Cell Lung Cancer
• Interventions: Drug: LY3295668 Erbumine

• Registration Number: NCT03898791
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-01
• Study First Submitted QC: 2019-04-01
• Study First Posted: 2019-04-02
• Study Start: 2019-07-16
• Primary Completion: 2020-06-02
• Study Completion: 2021-03-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-30
• Last Update Posted: 2021-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3295668 Part JP	LY3295668 Erbumine	LY3295668 erbumine administered orally.
LY3295668 Erbumine Cohort A	LY3295668 Erbumine	LY3295668 erbumine administered orally.
LY3295668 Erbumine Cohort B	LY3295668 Erbumine	LY3295668 erbumine administered orally.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Dose Reductions	Baseline through Cycle 1 (28 Day Cycle)	Number of Participants with Dose Reductions
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
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
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 Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (40)

Highlands Oncology Group; 🇺🇸 Fayetteville, Arkansas, United States

Rocky Mountain Cancer Center; 🇺🇸 Denver, Colorado, United States

H Lee Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Washington University Medical School; 🇺🇸 Saint Louis, Missouri, United States

Dartmouth Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Levine Cancer Institute- Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

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