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

Lilly

Status and phase: Completed; Phase 1

Conditions: Small Cell Lung Cancer

Treatments: Drug: LY3295668 Erbumine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03898791

17248

J1O-MC-JZHB (Other Identifier)

2018-003485-14 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

48 participants in 3 patient groups

LY3295668 Erbumine Cohort A

Experimental group

Description:

LY3295668 erbumine administered orally.

Treatment:

Drug: LY3295668 Erbumine

LY3295668 Erbumine Cohort B

Experimental group

Description:

LY3295668 erbumine administered orally.

Treatment:

Drug: LY3295668 Erbumine

LY3295668 Part JP

Experimental group

Description:

LY3295668 erbumine administered orally.

Treatment:

Drug: LY3295668 Erbumine