A Phase Ib, Multicenter, Randomized, Double-blind, Placebo-controlled Parallel Group Clinical Study Evaluating the Efficacy and Safety of Megestrol Acetate Oral Suspension in Preventing Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Proportion of Subjects Experiencing No Nausea During 0-168 Hours After Initiation of the First Chemotherapy Cycle
研究概览
简要总结
To evaluate the efficacy of Megestrol Acetate Oral Suspension in Preventing Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy in Malignant Solid Tumor Patients
详细描述
This multicenter, randomized, double-blind, placebo-controlled parallel-group study evaluates the efficacy, safety, and pharmacokinetic profile of megestrol acetate oral suspension in preventing nausea and vomiting induced by highly emetogenic chemotherapy. The trial plans to enroll 132 chemotherapy-naive malignant solid tumor patients scheduled to undergo initial single-day highly emetogenic chemotherapy regimens.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age ≥ 18 years, regardless of sex
- •Histologically or cytologically confirmed lung cancer
- •Expected survival ≥ 3 months
- •Female subjects of childbearing potential must have negative serum pregnancy test within 72 hours prior to randomization and must be non-lactating
- •Capable of comprehending and willingly providing signed informed consent form (ICF), and adhering to study requirements/restrictions Exclusion Criteria
- •Received or scheduled to receive concurrent radiotherapy within 7 days prior to enrollment through Day 1-8 of treatment
- •Systemic corticosteroid therapy or sedating antihistamines within 7 days prior to enrollment
- •Poorly controlled serous cavity effusions (pleural/peritoneal/pericardial)
- •Severe cardiovascular diseases within 3 months prior to enrollment
- •Participation in other clinical trials within 30 days prior to enrollment
排除标准
- 未提供
研究组 & 干预措施
Low dose of Megestrol Acetate Oral Suspension
干预措施: Low dose of Megestrol Acetate Oral Suspension combined with standard therapy (Drug)
Medium dose of Megestrol Acetate Oral Suspension
干预措施: Medium dose of Megestrol Acetate Oral Suspension combined with standard therapy (Drug)
High dose of Megestrol Acetate Oral Suspension
干预措施: High dose of Megestrol Acetate Oral Suspension combined with standard therapy (Drug)
Megestrol Acetate Oral Suspension Placebo
干预措施: Megestrol Acetate Oral Suspension Placebo combined with standard therapy (Drug)
结局指标
主要结局
Proportion of Subjects Experiencing No Nausea During 0-168 Hours After Initiation of the First Chemotherapy Cycle
时间窗: From 0 to 168 Hours After Initiation of Chemotherapy
Proportion of Subjects Experiencing No Nausea During 0-120 Hours After Initiation of the First Chemotherapy Cycle
时间窗: From 0 to 120 Hours After Initiation of Chemotherapy
次要结局
- Proportion of Subjects Achieving Complete Response (No significant nausea, No vomiting, etc. ) in the Acute, Delayed, Extended Delayed, 0-120 h, and 0-168 h Phases During the First Chemotherapy Cycle(From 0 to 168 Hours After Initiation of Chemotherapy)