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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 15
- 主要终点
- Percentage of Participants With Severe Diarrhea (≥ Grade 3)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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) ≤
- •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.
排除标准
- •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.
研究组 & 干预措施
200 mg Abemaciclib With a Meal
200 mg abemaciclib given twice a day (BID) orally with a meal.
干预措施: Abemaciclib (Drug)
200 mg Abemaciclib Without a Meal
200 mg abemaciclib given twice a day (BID) orally without a meal, taken in the modified fasted condition.
干预措施: Abemaciclib (Drug)
200 mg Abemaciclib Without Regard to Food
200 mg abemaciclib given twice a day (BID) orally without regard for food.
干预措施: Abemaciclib (Drug)
结局指标
主要结局
Percentage of Participants With Severe Diarrhea (≥ Grade 3)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Cycle 3 (28 Days Cycle)
Percentage of participants who discontinue treatment due to diarrhea
Percentage of Participants Utilizing Antidiarrheals
时间窗: Cycle 3 (28 Days Cycle)
Percentage of participants who utilized anti diarrheals at least once during the first 3 cycles.
次要结局
- 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 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(Cycle 1: Day 15; Cycle 2: Day1, Day 15; Cycle 3: Day 1 (28 Days Cycle))