A Phase 2, Double-blind, Placebo-Controlled Study to Evaluate LY3537021 for the Treatment of Chemotherapy-Induced Nausea and Vomiting in Adult Participants With Malignant Disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 204
- 试验地点
- 68
- 主要终点
- Proportion of Participants with a Complete Response (CR) in the Delayed Phase of CINV
研究概览
简要总结
The purpose of this study is to check how well LY35327021 works and how safe it is for controlling nausea and vomiting caused by chemotherapy. Participants who join this study will be in it until all parts are finished, which could take about 2 months.
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
- Double (Participant, Investigator)
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
- •Chemotherapy-naive participants, planned to receive AC or cisplatin-based chemotherapy greater than or equal to (≥)70 milligrams per square meter (mg/m²), on Day 1 of each cycle, with no multiple administrations during the CINV observation period, from Day 2 to Day 5 of each cycle.
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
排除标准
- •Have symptomatic or untreated central nervous system (CNS) metastases.
- •Have an established diagnosis of uncontrolled diabetes mellitus.
- •Have a history of, or current evidence of, a clinically significant cardiac condition or QT/QTcF-related conditions.
- •Have another etiology for nausea and vomiting, or receives medications with know or potential antiemetic activity
- •Signs, symptoms or history of thyroid tumors
- •Receives treatment with a gastric inhibitory polypetide (GIP) or glucagon-like peptide-1 (GLP-1) receptor agonist within 4 weeks prior to chemotherapy.
- •Have participated in a clinical study involving study intervention within 30 days of Cycle 1 Day 1 (C1D1). If the previous study intervention has a long half-life, within 3 months or 5 halflives, whichever is longer, of C1D
- •Are pregnant, breastfeeding, or intend to become pregnant during the study or within 30 days of the last dose of study intervention.
研究组 & 干预措施
Placebo + Antiemetic Therapies
Prior to chemotherapy, participants receive placebo administered SC with SOC antiemetic therapies orally, IV, or transdermally, per local label
干预措施: Placebo (Drug)
LY3537021 + Antiemetic Therapies
Prior to chemotherapy, participants receive LY3537021 administered subcutaneously (SC) with standard of care (SOC) antiemetic therapies orally, intravenously (IV), or transdermally, per local label
干预措施: Background Chemotherapy (Drug)
Placebo + Antiemetic Therapies
Prior to chemotherapy, participants receive placebo administered SC with SOC antiemetic therapies orally, IV, or transdermally, per local label
干预措施: Standard of Care Antiemetic Therapies (Drug)
Placebo + Antiemetic Therapies
Prior to chemotherapy, participants receive placebo administered SC with SOC antiemetic therapies orally, IV, or transdermally, per local label
干预措施: Background Chemotherapy (Drug)
LY3537021 + Antiemetic Therapies
Prior to chemotherapy, participants receive LY3537021 administered subcutaneously (SC) with standard of care (SOC) antiemetic therapies orally, intravenously (IV), or transdermally, per local label
干预措施: Standard of Care Antiemetic Therapies (Drug)
LY3537021 + Antiemetic Therapies
Prior to chemotherapy, participants receive LY3537021 administered subcutaneously (SC) with standard of care (SOC) antiemetic therapies orally, intravenously (IV), or transdermally, per local label
干预措施: LY3537021 (Drug)
结局指标
主要结局
Proportion of Participants with a Complete Response (CR) in the Delayed Phase of CINV
时间窗: 24 to 120 hours after first chemotherapy infusion
CR defined as no vomiting and no rescue medication
次要结局
- Proportion of Participants with a CR to CINV(Zero to 120 hours after the first chemotherapy infusion)
- Proportion of Participants with a Response of 0 in the Nausea Item of the Vomiting and Nausea Diary and No Rescue Medication(Zero to 120 hours after the first chemotherapy infusion)
- Proportion of Participants with a Response of Less than or Equal to (≤)3 in the Nausea Item of the Vomiting and Nausea Diary and No Rescue Medication(Zero to 120 hours after the first chemotherapy infusion)
- Pharmacokinetics (PK) Trough Concentrations (Ctrough) of LY3537021(From Day 1 of Cycle 1 until Day 1 of Cycle 2 (each cycle is expected to be 14, 21 or 28 days))