A Study of Abemaciclib (LY2835219) With and Without Food in Participants With Metastatic Breast Cancer

March 8, 2024 updated by: Eli Lilly and Company

An Open-Label, Randomized Phase 2 Study of the Impact of Food on Tolerability When Receiving Abemaciclib for Patients With Previously Treated Hormone Receptor-Positive, HER2-Negative, Metastatic Breast Cancer

The main purpose of this study is to examine the side effects that participants with metastatic breast cancer experience when taking abemaciclib with or without food.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • North Sydney, New South Wales, Australia, 2291
        • Mater Private Hospital
      • Sydney, New South Wales, Australia, 2010
        • St Vincent's Hospital
    • South Australia
      • Kurralta Park, South Australia, Australia, 5037
        • Ashford Cancer Centre Research
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Peter MacCallum Cancer Centre
  • Belgium
      • Leuven, Belgium, 3000
        • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
  • Russian Federation
      • Moscow, Russian Federation, 115478
        • Russian Oncological Research Center
      • Volgograd, Russian Federation, 400138
        • Volgograd Regional Clinical Oncology Dispensary
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain, 08023
        • Hospital Quirón Salud Barcelona-Instituto Oncológico Baselga
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28034
        • Hospital Ruber Internacional
  • Turkey
      • Antalya, Turkey, 07058
        • Akdeniz University Medical Faculty
      • Edirne, Turkey, 22030
        • Trakya University Faculty of Medicine
      • Izmir, Turkey, 35575
        • Medical Park Izmir Hospital
      • Malatya, Turkey, 44280
        • Inonu University Medical Faculty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Have a diagnosis of HR+, HER2- metastatic breast cancer (mBC).

  • Have all of the following:

    • Recurrent, locally advanced, unresectable or mBC with disease progression following anti-estrogen therapy.
    • Prior treatment with chemotherapy for locally advanced or metastatic disease.
    • No prior treatment with cyclin-dependent kinases (CDK) 4 and 6 inhibitor.
  • Have Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1.
  • Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy.
  • Have adequate organ function.
  • Women of child-bearing potential must have a negative pregnancy test.
  • Are able to swallow tablets/capsules.

Exclusion Criteria:

  • Are currently receiving treatment in a clinical study involving an investigational product.
  • Have a serious concomitant systemic disorder.
  • Have symptomatic central nervous system (CNS) malignancy or metastasis.
  • Have a symptomatic Human Immunodeficiency Virus (HIV) infection or symptomatic activated/reactivated hepatitis A, B, or C.
  • Have a personal history of syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.
  • Have a history of any other cancer.
  • Had major surgery within 14 days prior to randomization.
  • Are breastfeeding.
  • Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 200 mg Abemaciclib With a Meal
200 mg abemaciclib given twice a day (BID) orally with a meal.
Drug: Abemaciclib
Administered orally.
Other Names:
  • LY2835219
Experimental: 200 mg Abemaciclib Without a Meal
200 mg abemaciclib given twice a day (BID) orally without a meal, taken in the modified fasted condition.
Drug: Abemaciclib
Administered orally.
Other Names:
  • LY2835219
Experimental: 200 mg Abemaciclib Without Regard to Food
200 mg abemaciclib given twice a day (BID) orally without regard for food.
Drug: Abemaciclib
Administered orally.
Other Names:
  • LY2835219

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Severe Diarrhea (≥ Grade 3)
Time Frame: Cycle 3 (28 Days Cycle)
Percentage of participants with severe diarrhea (≥ grade 3) during the first 3 cycles. Events were as assessed by the investigator and graded according to Common Terminology Criteria for Adverse Events (CTCAE). Grade 3 was defined as an increase of ≥7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self-care activities of daily living (ADL).
Cycle 3 (28 Days Cycle)
Percentage of Participants With Prolonged Grade 2 Diarrhea
Time Frame: Cycle 3 (28 Days Cycle)
Percentage of participants with prolonged grade 2 diarrhea during first 3 cycles. Events were as assessed by the investigator and graded according to Common Terminology Criteria for Adverse Events (CTCAE). Prolonged Grade 2 diarrhea was any event lasting more than 7 days. Grade 2 was defined as Increase of 4-6 stools per day over baseline; moderate increase in ostomy output compared to baseline.
Cycle 3 (28 Days Cycle)
Percentage of Participants With Dose Reductions Due to Diarrhea
Time Frame: Cycle 3 (28 Days Cycle)
Percentage of participants with dose reductions due to diarrhea during first 3 cycles.
Cycle 3 (28 Days Cycle)
Percentage of Participants With Dose Interruptions Due to Diarrhea
Time Frame: Cycle 3 (28 Days Cycle)
Percentage of participants with dose interruptions due to diarrhea during first 3 cycles.
Cycle 3 (28 Days Cycle)
Percentage of Participants Who Discontinue Treatment Due to Diarrhea
Time Frame: Cycle 3 (28 Days Cycle)
Percentage of participants who discontinue treatment due to diarrhea
Cycle 3 (28 Days Cycle)
Percentage of Participants Utilizing Antidiarrheals
Time Frame: Cycle 3 (28 Days Cycle)
Percentage of participants who utilized anti diarrheals at least once during the first 3 cycles.
Cycle 3 (28 Days Cycle)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib
Time Frame: Cycle 1: Day 15; Cycle 2: Day 1, Day 15; Cycle 3: Day 1 (28 Days Cycle)
PK: Mean steady state exposure of abemaciclib
Cycle 1: Day 15; Cycle 2: Day 1, Day 15; Cycle 3: Day 1 (28 Days Cycle)
PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN2839567
Time Frame: Cycle 1: Day 15; Cycle 2: Day1, Day 15; Cycle 3: Day 1 (28 Days Cycle)
PK: Mean steady state exposure of abemaciclib metabolite LSN2839567
Cycle 1: Day 15; Cycle 2: Day1, Day 15; Cycle 3: Day 1 (28 Days Cycle)
PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN3106726
Time Frame: Cycle 1: Day 15; Cycle 2: Day1, Day 15; Cycle 3: Day 1 (28 Days Cycle)
PK: Mean steady state exposure of abemaciclib metabolite LSN3106726
Cycle 1: Day 15; Cycle 2: Day1, Day 15; Cycle 3: Day 1 (28 Days Cycle)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 28, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 29, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 9, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 5, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17041
  • I3Y-MC-JPCP (Other Identifier: Eli Lilly and Company)
  • 2018-001853-28 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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