NCT03079219已完成3 期
A Randomized Study to Determine the Efficacy and Tolerability of Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Chinese Breast Cancer Patients
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- CCTU
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Number of episodes of vomiting in the first 120 hours after first cycle of chemotherapy.
研究概览
简要总结
The Olanzapine Regimen will be superior to the Standard Regimen, as measured by the proportion of patients with Complete Response in the 120 hours following AC chemotherapy.
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 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Chinese patient, female >=18 and < 75 years of age.
- •Patient is diagnosed with early breast cancer.
- •Patient is naïve to emetogenic chemotherapy moderately or highly emetogenecity.
- •Patient is scheduled to receive her first course of adjuvant chemotherapy for breast cancer follows:
- •IV adriamycin 60 mg/m2 + cyclophosphamide 600 mg/m2
- •Patient has a predicted life expectancy of >=4 months.
- •Patient has ECOG Performance Status of 0-1
- •Premenopausal female patients must not be pregnant (documented negative urine pregnancy test).
- •Patient is able to read, understand and complete study questionnaires and diary, including questions requiring a visual analog scale (VAS) response.
- •Patient understands the procedures and agrees to participate in the study by giving written informed consent
排除标准
- •Patient with advanced breast cancer.
- •Patient receiving cisplatin or any other chemotherapy of higher emetogenic potential, except for cyclophosphamide and doxorubicin in the regimens described above.
- •Patients who are scheduled to receive concurrent radiation as part of their chemotherapy regimen for their malignancy
- •Patients who experience any vomiting or grade 2-3 nausea per Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v 4.03) in the 24 hours before Day 1 of chemotherapy
- •Patient has a history of treatment with moderately to highly emetogenic chemotherapy.
- •Patient has an active infection (e.g., pneumonia, systemic fungal infection) or any uncontrolled disease (e.g., diabetes mellitus, hypertension) which, in the opinion of the investigator, might confound the results of the study or pose unwarranted risk.
- •Patient with history of glaucoma, dementia, seizures, Parkinson's disease, Neuroleptic Malignant Syndrome (NMS), thromboembolic events.
- •Patient currently uses any illicit drugs, including marijuana, or has current evidence of alcohol abuse as determined by the investigator.
- •Patient is mentally incapacitated or has a significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry.
- •Patients who are regular alcohol drinker or smoker
- •Patient has a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose unwarranted risk.
- •Patient has a history of hypersensitivity to aprepitant, ondansetron or dexamethasone.
- •Patients who have phenylketonuria and abnormal uric acid.
- •Any investigational drugs taken within 4 weeks prior to Day 1 of cycle 1, and/or is scheduled to receive any investigational drug during the study;
- •Patient is taking systemic corticosteroid therapy at any dose; however, topical and inhaled corticosteroids are permitted.
- •Patient has taken a non-registered investigational drug within the 28 days of the Prestudy Visit.
- •Use, in the 28 days prior to Treatment Day 1, of barbiturates, rifampicin or rifabutin, phenytoin or carbamazepine
- •Use, in the 7 days prior to Treatment Day 1, of terfenadine, cisapride, astemizole, clarithromycin (azithromycin, erythromycin and roxithromycin are permitted), ketoconazole or itraconazole (fluconazole is permitted), amifostine pimozide 5-HT3 antagonists (ondansetron, granisetron, dolasetron, or tropisetron) phenothiazines (e.g., prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine) butyrophenones (e.g., haloperidol or droperidol) benzamides (e.g., metoclopramide or alizapride) domperidone cannabinoids NK1 receptor antagonists
- •Use, in the 48 hours prior to Treatment Day 1, of benzodiazepines or opiates, except for single daily doses of lorazepam.
- •s. Use of the following drugs: carbamazepine Fluvoxamine ciprofloxacin dopamine agonists. antiparkinsonian medicinal products medicinal products known to increase QTc interval t. Abnormal laboratory values
结局指标
主要结局
Number of episodes of vomiting in the first 120 hours after first cycle of chemotherapy.
时间窗: 120 hours
Number of episodes of vomiting in the first 120 hours after first cycle of chemotherapy.
Number of episodes of nausea in the first 120 hours after first cycle of chemotherapy.
时间窗: 120 hours
Number of episodes of nausea in the first 120 hours after first cycle of chemotherapy.
次要结局
- Number of episodes of vomiting in the first 120 hours during 4 cycles of chemotherapy.(120 hours)
- Number of episodes of nausea in the first 120 hours during 4 cycles of chemotherapy.(120 hours)
研究者
CCTU
Comprehensive Clinical Trial Unit
Chinese University of Hong Kong
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Study of Olanzapine vs. Aripiprazole in the Treatment of SchizophreniaSchizophreniaNCT00088049Eli Lilly and Company560
终止
4 期
A Study in the Treatment of Acute ManiaBipolar DisorderNCT00767715Eli Lilly and Company11
已完成
3 期
Efficacy and Safety of Olanzapine in Patients With Borderline Personality DisorderBorderline Personality DisorderNCT00088036Eli Lilly and Company450
已完成
不适用
Long-acting Paliperidone Palmitate Injection and Olanzapine for SchizophreniaSchizophreniaNCT02918825Beijing HuiLongGuan Hospital100
已完成
4 期
Optimal Length of Treatment Continuation With Olanzapine After Remission of Manic or Mixed EpisodeBipolar DisorderNCT00191997Eli Lilly and Company180