NCT04536558Unknown3 期
Olanzapine Plus Fosaprepitant Standard Antiemetic Therapy in the Prevention of Chemotherapy-induced Nausea and Vomiting in Patients Receiving High Emetic Risk Multi-day Chemotherapy: a Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study（OFFER）
Sun Yat-sen University18 个研究点 分布在 1 个国家目标入组 352 人开始时间: 2020年10月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 352
- 试验地点
- 18
- 主要终点
- Complete response (CR) during overall phase
研究概览
简要总结
This is a multicenter, randomized, controlled, double-blind, phase III study.
详细描述
This is a multicenter, randomized, controlled, double-blind, phase III study assessing the efficacy and safety of Olanzapine plus fosaprepitant plus ondansetron and dexamethasone versus fosaprepitant plus ondansetron and dexamethasone in the prevention of chemotherapy-induced nausea and vomiting in patients receiving high emetic risk multi-day chemotherapy. Eligible patients will be randomized to receive either olanzapine plus fosaprepitant standard antiemetic therapy or fosaprepitant standard antiemetic therapy in a 1:1 ratio.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(abbreviated)
- •Male and female patients aged ≥ 18 and ≤ 75 years old;
- •Patients were diagnosed with histologically or cytology confirmed solid malignant tumors;
- •Patients have a Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2;
- •Patients were predicted life expectancy of ≥ 3 months;
- •Patients who were scheduled for 3 days of cisplatin based chemotherapy.
排除标准
- •(abbreviated)
- •Patients were mentally disable or suffered from emotional disorders;
- •Patients were current illicit drug use, including alcohol abuse;
- •Patients scheduled administration of stem cell rescue therapy during cisplatin chemotherapy;
- •Patients have participated in other clinical trials in the past 4 weeks;
- •Patients were treated with chemotherapy including ordinary paclitaxel(using castor oil as a solvent);
- •Patients with active infections (e.g., pneumonia) or any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction) other than malignant tumors, and the researchers believe that it may confound the results of the study or expose patients receiving treatment with the study drug at unnecessary risk;
- •Patients have any disease that the researcher believes may confound the results of the study or expose the patient to unnecessary risk；
- •Patients were treated with moderate or highly emetogenic chemotherapy within 6 days prior to the initial of cisplatin infusion and/or 6 days after cisplatin infusion;
- •Patients were scheduled to receive radiation therapy to the abdomen or pelvis within a week of treatment;
- •Absolute neutrophil count<1,500 cells/ L, white blood cell count<3,000 cells/ L, platelet count<100,000 cells/ L, aspartate aminotransferase and alanine aminotransferase>2.5 upper limit of normal (ULN), bilirubin > 1.5 ULN, and creatinine > 1.5 ULN;
- •Patients were pregnant or breastfeeding;
- •Patients had suffered from vomiting or nausea in the 24 hours before treatment;
- •Patients were known to be at risk for narrow angle glaucoma；
- •Patients who are taking or have used CYP3A4 inducers within 30 days before the first day of treatment, which will affect the efficacy of the treatment drugs according to the researcher's evaluation, can not be enrolled;
- •Patients who are taking or have used CYP3A4 substrates and inhibitors within 7 days before the first day of treatment will significantly increase the treatment drug-related adverse events according to the researcher's evaluation, can not be enrolled;
- •Within 48 hours before the first day of treatment, patients used the following antiemetic agents: 5-hydroxytryptamine 3 receptor antagonists (such as ondansetron), phenothiazines (such as prochlorperazine), benzophenones (such as haloperidol), benzamide (such as metoclopramide), domperidone, cannabinoids, herbs with potential antiemetic effects, scopolamine, and cyclizine, etc;
- •Patients began to receive benzodiazepines or opioids within 48 hours prior to the first day of the study (except for triazolam, temazepam or midazolam single dose daily);
- •Patients had symptomatic primary or metastatic central nervous system malignancies;
- •Patients had concomitant diseases that could not take dexamethasone for 5 days, such as systemic fungal infection or uncontrolled diabetes mellitus;
- •Patients were not allowed to receive any dose of systemic glucocorticoid therapy within 72 hours before the first day except those prescribed in the protocol; however, local and inhaled corticosteroids were allowed;
- •Patients had a history of hypersensitivity to fosaprepitant meglumine, olanzapine, ondansetron or dexamethasone；
- •Patients had been treated with neurokinin-1 receptor antagonist in the past;
研究组 & 干预措施
olanzapine plus fosaprepitant-based triple regimen
Experimental
Olanzapine（5mg p.o. d1-d5）plus fosaprepitant（150mg i.v. d1-d3） plus ondansetron（8mg i.v. d1-d3）and dexamethasone（6mg p.o. d1-d5） before undergoing chemotherapy.
干预措施: olanzapine plus fosaprepitant-based triple regimen (Drug)
Placebo plus fosaprepitant-based triple regimen
Placebo Comparator
Placebo plus fosaprepitant（150mg i.v. d1-d3） plus ondansetron（8mg i.v. d1-d3）and dexamethasone（6mg p.o. d1-d5） before undergoing chemotherapy.
干预措施: placebo plus fosaprepitant-based triple regimen (Drug)
结局指标
主要结局
Complete response (CR) during overall phase
时间窗: Day 1 to day 8 after highly emetogenic chemotherapy initiation
To compare olanzapine plus fosaprepitant regimen with placebo plus fosaprepitant regimen with respect to efficacy; complete response (CR) defined as no vomiting and no use of rescue therapy during overall phase (day 1 to day 8） after highly emetogenic chemotherapy initiation)
次要结局
- To compare quality of life using the functional living index-emesis questionnaire(From baseline to day 8 after highly emetogenic chemotherapy initiation)
- Complete response (CR) during acute phase(Day 1 to day 3 days after highly emetogenic chemotherapy initiation)
- No significant nausea during overall phase using questionnaire(Day 1 to day 8 after highly emetogenic chemotherapy initiation)
- To compare the change of score using Hospital Anxiety and Depression Scale(From baseline to day 8 after highly emetogenic chemotherapy initiation)
- Complete response (CR) during delayed phase(Day 4 to day 8 after highly emetogenic chemotherapy initiation)
- No significant nausea during acute phase using questionnaire(Day 1 to day 3 after highly emetogenic chemotherapy initiation)
- No significant nausea during delayed phase using questionnaire(Day 4 to day 8 after highly emetogenic chemotherapy initiation)
- To compare olanzapine plus fosaprepitant regimen with placebo plus fosaprepitant regimen in terms of the number of days to first emetic episode.(Day 1 to day 8 after highly emetogenic chemotherapy initiation)
- To compare the number of participants with treatment-related adverse events as assessed by CTCAE v4.0(From baseline to day 8 after highly emetogenic chemotherapy initiation)
研究者
Li Zhang, MD
head of the medical department
Sun Yat-sen University
研究点 (18)
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