A Study of Abemaciclib (LY2835219) With and Without Food in Participants With Metastatic Breast Cancer
- Registration Number
- NCT03703466
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
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Have a diagnosis of HR+, HER2- metastatic breast cancer (mBC).
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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.
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Have Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1.
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Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy.
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Have adequate organ function.
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Women of child-bearing potential must have a negative pregnancy test.
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 200 mg Abemaciclib Without Regard to Food Abemaciclib 200 mg abemaciclib given twice a day (BID) orally without regard for food. 200 mg Abemaciclib With a Meal Abemaciclib 200 mg abemaciclib given twice a day (BID) orally with a meal. 200 mg Abemaciclib Without a Meal Abemaciclib 200 mg abemaciclib given twice a day (BID) orally without a meal, taken in the modified fasted condition.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Severe Diarrhea (≥ Grade 3) 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 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 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 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 Cycle 3 (28 Days Cycle) Percentage of participants who discontinue treatment due to diarrhea
Percentage of Participants Utilizing Antidiarrheals Cycle 3 (28 Days Cycle) Percentage of participants who utilized anti diarrheals at least once during the first 3 cycles.
- Secondary Outcome Measures
Name Time Method Pharmacokinetics (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
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 LSN2839567
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) PK: Mean steady state exposure of abemaciclib metabolite LSN3106726
Trial Locations
- Locations (15)
Akdeniz University Medical Faculty
🇹🇷Antalya, Turkey
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Medical Park Izmir Hospital
🇹🇷Izmir, Turkey
Hospital Quirón Salud Barcelona-Instituto Oncológico Baselga
🇪🇸Barcelona, Spain
Volgograd regional clinical oncology dispensary
🇷🇺Volgograd, Russian Federation
Peter MacCallum Cancer Centre
🇦🇺Melbourne, Victoria, Australia
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
🇧🇪Leuven, Belgium
Ashford Cancer Centre Research
🇦🇺Kurralta Park, South Australia, Australia
Russian Oncological Research Center
🇷🇺Moscow, Russian Federation
Hospital Ruber Internacional
🇪🇸Madrid, Spain
Trakya University Faculty of Medicine
🇹🇷Edirne, Turkey
Mater Private Hospital
🇦🇺North Sydney, New South Wales, Australia
St Vincent's Hospital
🇦🇺Sydney, New South Wales, Australia
Inonu University Medical Faculty
🇹🇷Malatya, Turkey