A Study of Abemaciclib (LY2835219) With and Without Food in Participants With Metastatic Breast Cancer
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|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
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|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: Abemaciclib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: 200 mg Abemaciclib With a Meal
200 mg abemaciclib given twice a day (BID) orally with a meal.
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.
Other Name: LY2835219
Experimental: 200 mg Abemaciclib Without Regard to Food
200 mg abemaciclib given twice a day (BID) orally without regard for food.
Other Name: LY2835219
- 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).
- 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.
- 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.
- 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.
- 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
- 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.
- 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
- 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
- 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
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:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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
|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|
|Peter MacCallum Cancer Centre|
|Melbourne, Victoria, Australia, 3000|
|Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg|
|Leuven, Belgium, 3000|
|Russian Oncological Research Center|
|Moscow, Russian Federation, 115478|
|Volgograd regional clinical oncology dispensary|
|Volgograd, Russian Federation, 400138|
|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|
|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|
|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|
Documents provided by Eli Lilly and Company:
|Responsible Party:||Eli Lilly and Company|
|Other Study ID Numbers:||
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.|
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.|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
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