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

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: NCT03703466
Recruitment Status : Active, not recruiting
First Posted : October 12, 2018
Results First Posted : August 13, 2020
Last Update Posted : May 9, 2023
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Abemaciclib Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 28, 2018
Actual Primary Completion Date : July 29, 2019
Estimated Study Completion Date : September 20, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Abemaciclib

Arms and Interventions
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Arm Intervention/treatment
Experimental: 200 mg Abemaciclib With a Meal
200 mg abemaciclib given twice a day (BID) orally with a meal.
 Drug: Abemaciclib
Administered orally.
Other Name: 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 Name: 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 Name: LY2835219


Outcome Measures
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Primary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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


Eligibility Criteria
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Information from the National Library of Medicine

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.


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

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.
Contacts and Locations
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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): NCT03703466


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

Documents provided by Eli Lilly and Company:
Study Protocol  [PDF] February 10, 2020
Statistical Analysis Plan  [PDF] November 8, 2018

More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03703466    
Other Study ID Numbers: 17041
I3Y-MC-JPCP ( Other Identifier: Eli Lilly and Company )
2018-001853-28 ( EudraCT Number )
First Posted: October 12, 2018    Key Record Dates
Results First Posted: August 13, 2020
Last Update Posted: May 9, 2023
Last Verified: May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases