Clinical trial NCT03955939: A Study of LY3295668 Erbumine in Participants With Breast Cancer That Has Spread to Other Parts of the Body
Official title: A Phase 1b Study of Aurora A Kinase Inhibitor LY3295668 Erbumine in Monotherapy and Combination Therapy in Patients With Metastatic Breast Cancer Post CDK4/6 Inhibitor and Endocrine Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metastatic Breast Cancer
Keywords: aurora kinase A
kinase
aurora A
aurora kinase inhibitor
aurora kinase A inhibitor
kinase inhibitor
AURKA
AurA
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-05-20
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with Dose Reductions
timeFrame: Baseline through Cycle 1 (28 Day Cycle)
measure: Part II: Number of Participants with Dose Limiting Toxicities (DLTs)
timeFrame: Baseline through Cycle 1 (28 Day Cycle)
measure: Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
timeFrame: Baseline through Measured Progressive Disease (Estimated up to 23 Months)
measure: Duration of Response (DoR)
timeFrame: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 23 Months)
Secondary outcomes:
measure: Clinical Benefit Rate (CBR): Percentage of Participants Who Achieve CR, PR or SD With a Duration of At Least 6 Months
timeFrame: Baseline through Disease Progression or Death Due to Any Cause (Estimated up to 23 Months)
measure: Progression-Free Survival (PFS)
timeFrame: Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 23 Months)
measure: Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668
timeFrame: Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
measure: PK: AUC of LY3295668 in Combination with Endocrine Therapy
timeFrame: Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
measure: PK: AUC of Endocrine Therapy in Combination with LY3295668
timeFrame: Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
measure: PK: AUC of Midazolam
timeFrame: Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
measure: PK: AUC of Midazolam in Combination with LY3295668
timeFrame: Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics, LLC
state: Texas
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: