EUCTR2007-005068-29-PL进行中（未招募）不适用
A Pivotal Phase 3 Observer-Blind, Randomized Clinical Trial of the Efficacy and Safety of APF530 Compared to Aloxi® for the Prevention of Acute-Onset and Delayed-Onset Chemotherapy-Induced Nausea and Vomiting Following the Administration of either Moderately or Highly Emetogenic Chemotherapy Regimens
A.P. Pharma, Inc.0 个研究点目标入组 1,338 人开始时间: 2007年10月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,338
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Diagnosis and main criteria for inclusion and exclusion:
- •Subject Population: Male or female subjects = 18 years of age, with histologically or cytologically confirmed malignant disease, and scheduled to receive single-day administrations of moderately or highly emetogenic chemotherapy (determined using the Hesketh algorithm). Administration of chemotherapy should not extend beyond 4 hours excluding administration of monoclonal antibodies. Chemotherapy administrations must be separated by at least 7 days but should not be more than 28(+3) days apart. Study drug administrations cannot be more than 28(+ 3) days apart.
- •Inclusion: Men and women 18 years of age or older who are scheduled to receive moderately emetogenic (Hesketh Level 3 and 4) or highly emetogenic (Hesketh Level 5) chemotherapy; have histologically or cytologically confirmed malignant disease; are able to receive the standardized doses of dexamethasone, as required by this protocol; have Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2; are willing and able to comply with all testing and requirements defined in this protocol; are willing and able to provide voluntary, written, informed consent to participate in this study, and the ability to fully understand the study requirements. Eligible patients are not required to be chemotherapy naïve. Female subjects cannot be pregnant and must be adequately protected from conception for the duration of study. It is recommended that females and female partners of male subjects remain adequately protected from conception for up to one year following study participation.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion: Treatment with chemotherapeutic regimens which are mildly or unlikely to be emetogenic (Hesketh Level 1 and 2); allergy or hypersensitivity to 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists or to local anesthetics; ECOG performance status of 3, 4 or 5; head and neck cancers that have compromised the brain vomiting and nausea centers, primary brain tumors and active/symptomatic brain metastases, or GI cancers with gastric or intestinal obstruction that may result in symptoms of nausea and vomiting; a psychological problem that, in the investigator’s opinion, is severe enough to preclude reliable study participation; recent history (within 1 year) of alcohol or drug abuse; greater than mild nausea or any vomiting within 24 hours prior to study drug administration; pregnancy (confirmed by serum or urine test) or breastfeeding; any concomitant condition that, in the opinion of the investigator, could affect assessment of the study drug or could interfere with the nausea/vomiting response, including severe renal or hepatic impairment; use of investigational drug within 30 days before study entry; subjects with QTc interval > 500 msec or with a cardiac abnormality predisposing the subject to arrhythmia.
研究者
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