A Study of LY3295668 Erbumine in Participants With Breast Cancer That Has Spread to Other Parts of the Body
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03955939 |
Recruitment Status :
Completed
First Posted : May 20, 2019
Last Update Posted : June 1, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metastatic Breast Cancer | Drug: LY3295668 Erbumine Drug: Endocrine therapy Drug: Midazolam | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 5 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | August 2, 2019 |
Actual Primary Completion Date : | May 14, 2020 |
Actual Study Completion Date : | May 14, 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: LY3295668 Erbumine Part A
LY3295668 erbumine administered orally (Part I). Approximately the first 10 participants enrolled in this arm will be administered midazolam. |
Drug: LY3295668 Erbumine
Administered orally. Drug: Midazolam Administered orally. |
Experimental: LY3295668 Erbumine Part B
LY3295668 erbumine administered orally (Part I). Approximately the first 10 participants enrolled in this arm will be administered midazolam. |
Drug: LY3295668 Erbumine
Administered orally. Drug: Midazolam Administered orally. |
Experimental: LY3295668 Erbumine + Endocrine Therapy Cohort 1
LY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part II).
|
Drug: LY3295668 Erbumine
Administered orally. Drug: Endocrine therapy Administered according to label instructions. |
Experimental: LY3295668 Erbumine + Endocrine Therapy Continuation Part C
LY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part I).
|
Drug: LY3295668 Erbumine
Administered orally. Drug: Endocrine therapy Administered according to label instructions. |
Experimental: LY3295668 Erbumine + Endocrine Therapy Switch Part D
LY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part I).
|
Drug: LY3295668 Erbumine
Administered orally. Drug: Endocrine therapy Administered according to label instructions. |
- Number of Participants with Dose Reductions [ Time Frame: Baseline through Cycle 1 (28 Day Cycle) ]Number of Participants with Dose Reductions
- Part II: Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Baseline through Cycle 1 (28 Day Cycle) ]Part II: Number of Participants with DLTs
- Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) [ Time Frame: Baseline through Measured Progressive Disease (Estimated up to 23 Months) ]ORR
- Duration of Response (DoR) [ Time Frame: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 23 Months) ]DoR
- Clinical Benefit Rate (CBR): Percentage of Participants Who Achieve CR, PR or SD With a Duration of At Least 6 Months [ Time Frame: Baseline through Disease Progression or Death Due to Any Cause (Estimated up to 23 Months) ]CBR
- Progression-Free Survival (PFS) [ Time Frame: Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 23 Months) ]PFS
- Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668 [ Time Frame: Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) ]PK: AUC of LY3295668
- PK: AUC of LY3295668 in Combination with Endocrine Therapy [ Time Frame: Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) ]PK: AUC of LY3295668 in Combination with Endocrine Therapy
- PK: AUC of Endocrine Therapy in Combination with LY3295668 [ Time Frame: Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) ]PK: AUC of Endocrine Therapy in Combination with LY3295668
- PK: AUC of Midazolam [ Time Frame: Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) ]PK: AUC of Midazolam
- PK: AUC of Midazolam in Combination with LY3295668 [ Time Frame: Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) ]PK: AUC of Midazolam in Combination with LY3295668
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03955939
United States, California | |
City of Hope National Medical Center | |
Duarte, California, United States, 91010-0269 | |
United States, Massachusetts | |
Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United States, Texas | |
South Texas Accelerated Research Therapeutics, LLC | |
San Antonio, Texas, United States, 78229-3307 | |
Belgium | |
Cliniques Universitaires Saint-Luc | |
Brussels, Belgium, 1200 | |
Universitair Ziekenhuis Antwerpen | |
Edegem, Belgium, 2650 | |
Universitair Ziekenhuis Gent | |
Gent, Belgium, 9000 | |
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg | |
Leuven, Belgium, 3000 |
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 |
Responsible Party: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT03955939 |
Other Study ID Numbers: |
17249 J1O-MC-JZHC ( Other Identifier: Eli Lilly and Company ) 2018-004183-61 ( EudraCT Number ) |
First Posted: | May 20, 2019 Key Record Dates |
Last Update Posted: | June 1, 2020 |
Last Verified: | May 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
aurora kinase A kinase aurora A aurora kinase inhibitor |
aurora kinase A inhibitor kinase inhibitor AURKA AurA |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Midazolam Adjuvants, Anesthesia Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs |
Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs Anesthetics, Intravenous Anesthetics, General Anesthetics GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |