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

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ClinicalTrials.gov Identifier: NCT03955939
Recruitment Status : Completed
First Posted : May 20, 2019
Last Update Posted : June 1, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: LY3295668 Erbumine Drug: Endocrine therapy Drug: Midazolam Phase 1

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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.




Primary Outcome Measures :
  1. Number of Participants with Dose Reductions [ Time Frame: Baseline through Cycle 1 (28 Day Cycle) ]
    Number of Participants with Dose Reductions

  2. 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

  3. 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

  4. 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


Secondary Outcome Measures :
  1. 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

  2. Progression-Free Survival (PFS) [ Time Frame: Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 23 Months) ]
    PFS

  3. 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

  4. 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

  5. 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

  6. PK: AUC of Midazolam [ Time Frame: Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) ]
    PK: AUC of Midazolam

  7. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
Additional Information:
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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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
aurora kinase A
kinase
aurora A
aurora kinase inhibitor
aurora kinase A inhibitor
kinase inhibitor
AURKA
AurA
Additional relevant MeSH terms:
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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