A Study of LY3295668 Erbumine in Participants With Breast Cancer That Has Spread to Other Parts of the Body
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
3 other identifiers
interventional
5
2 countries
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2019
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2019
CompletedFirst Posted
Study publicly available on registry
May 20, 2019
CompletedStudy Start
First participant enrolled
August 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 14, 2020
CompletedJune 1, 2020
May 1, 2020
10 months
May 17, 2019
May 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Number of Participants with Dose Reductions
Number of Participants with Dose Reductions
Baseline through Cycle 1 (28 Day Cycle)
Part II: Number of Participants with Dose Limiting Toxicities (DLTs)
Part II: Number of Participants with DLTs
Baseline through Cycle 1 (28 Day Cycle)
Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
ORR
Baseline through Measured Progressive Disease (Estimated up to 23 Months)
Duration of Response (DoR)
DoR
Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 23 Months)
Secondary Outcomes (7)
Clinical Benefit Rate (CBR): Percentage of Participants Who Achieve CR, PR or SD With a Duration of At Least 6 Months
Baseline through Disease Progression or Death Due to Any Cause (Estimated up to 23 Months)
Progression-Free Survival (PFS)
Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 23 Months)
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668
Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
PK: AUC of LY3295668 in Combination with Endocrine Therapy
Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
PK: AUC of Endocrine Therapy in Combination with LY3295668
Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
- +2 more secondary outcomes
Study Arms (5)
LY3295668 Erbumine Part A
EXPERIMENTALLY3295668 erbumine administered orally (Part I). Approximately the first 10 participants enrolled in this arm will be administered midazolam.
LY3295668 Erbumine Part B
EXPERIMENTALLY3295668 erbumine administered orally (Part I). Approximately the first 10 participants enrolled in this arm will be administered midazolam.
LY3295668 Erbumine + Endocrine Therapy Cohort 1
EXPERIMENTALLY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part II).
LY3295668 Erbumine + Endocrine Therapy Continuation Part C
EXPERIMENTALLY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part I).
LY3295668 Erbumine + Endocrine Therapy Switch Part D
EXPERIMENTALLY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part I).
Interventions
Administered orally.
Administered according to label instructions.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
City of Hope National Medical Center
Duarte, California, 91010-0269, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, 78229-3307, United States
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, 2650, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, 3000, Belgium
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2019
First Posted
May 20, 2019
Study Start
August 2, 2019
Primary Completion
May 14, 2020
Study Completion
May 14, 2020
Last Updated
June 1, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share