A Study of LY3295668 Erbumine in Participants With Breast Cancer That Has Spread to Other Parts of the Body

Lilly

Status and phase: Completed; Phase 1

Conditions: Metastatic Breast Cancer

Treatments: Drug: Midazolam; Drug: LY3295668 Erbumine; Drug: Endocrine therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT03955939

J1O-MC-JZHC (Other Identifier)

17249

2018-004183-61 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 5 patient groups

LY3295668 Erbumine Part A

Experimental group

Description:

LY3295668 erbumine administered orally (Part I). Approximately the first 10 participants enrolled in this arm will be administered midazolam.

Treatment:

Drug: Midazolam

Drug: LY3295668 Erbumine

LY3295668 Erbumine Part B

Experimental group

Description:

LY3295668 erbumine administered orally (Part I). Approximately the first 10 participants enrolled in this arm will be administered midazolam.

Treatment:

Drug: Midazolam

Drug: LY3295668 Erbumine

LY3295668 Erbumine + Endocrine Therapy Cohort 1

Experimental group

Description:

LY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part II).

Treatment:

Drug: Endocrine therapy

Drug: LY3295668 Erbumine

LY3295668 Erbumine + Endocrine Therapy Continuation Part C

Experimental group

Description:

LY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part I).

Treatment:

Drug: Endocrine therapy

Drug: LY3295668 Erbumine

LY3295668 Erbumine + Endocrine Therapy Switch Part D

Experimental group

Description:

LY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part I).

Treatment:

Drug: Endocrine therapy

Drug: LY3295668 Erbumine