NCT01303978已完成2 期
Open-label, Ascending-dose, Phase II Study to Determine the Minimum Effective Dose of APD421 in the Prevention of Cisplatin-induced Nausea and Vomiting
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 4
- 主要终点
- Complete Response
研究概览
简要总结
Evaluation of efficacy of APD421 in preventing nausea and vomiting caused by cisplatin
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Male or female patients ≥ 18 years of age
- •Ability and willingness to give written informed consent
- •Patients scheduled to receive, on day 1 of their chemotherapy, a first cisplatin chemotherapy infusion at a dose of 50 mg/m2 or greater
- •Karnofsky performance score ≥ 60%
- •Adequate cardiac, hepatic and renal function
- •QTc interval < 500 ms
- •Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) < 5 x upper limit normal (ULN)
- •Bilirubin < 3 x ULN
- •Creatinine < 2 x ULN
- •Adequate haematological function
- •Haemoglobin ≥ 9 g/dL
- •White blood count ≥ 3.0 x 109/L
- •Platelet count ≥ 100 x 109/L
- •For females of child-bearing potential: ability and willingness to use a highly effective form of contraception (e.g., abstinence from sexual intercourse, surgical sterilisation (of subject or partner) or a double-barrier method of contraception such as either an intra-uterine device (IUD) or an occlusive cap with spermicide, in conjunction with partner's use of a condom) during the study and for a period of at least 48 hours afterwards.
排除标准
- •Patients scheduled to receive, prior to or in the 24 hours after cisplatin, any chemotherapeutic agent with a high or moderate emetic risk, see Appendix
- •Patients scheduled to receive paclitaxel or docetaxel
- •Patients undergoing abdominal or pelvic irradiation within 48 hours prior to screening or scheduled to receive abdominal or pelvic irradiation between screening and 24 hours after cisplatin administration
- •Patients receiving APD421 for any indication within the last 2 weeks
- •Patients who are allergic to APD421 or any of the excipients of APD421
- •Patients with a pre-existing vestibular disorder
- •Patients being treated with regular anti-emetic therapy including corticosteroids
- •Patients receiving inhaled corticosteroids, unless started more than one month prior to the expected date of study entry
- •Patients being treated with medications which could induce torsades de pointes, including Class Ia antiarrhythmic agents such as quinidine, disopyramide, procainamide; Class III antiarrhythmic agents such as amiodarone and sotalol; and other medications such as bepridil, cisapride, thioridazine, methadone, IV erythromycin, IV vincamine, halofantrine, pentamidine, sparfloxacin
- •Patients being treated with xxx
- •Patients receiving benzodiazepines, unless on a stable dose for at least one month prior to the expected date of study entry
- •Patients with pre-existing nausea or vomiting in the 24 hours before receiving cisplatin chemotherapy, e.g. anticipatory emesis
- •Patients who are pregnant or breast feeding
- •Patients with a history of alcohol abuse
- •Patients with pre-existing, clinically significant cardiac arrhythmia
- •Any other concurrent disease or illness that, in the opinion of the investigator makes the patient unsuitable for the study
- •Patients who have participated in another study within the previous 28 days
研究组 & 干预措施
APD421 starting dose
Experimental
干预措施: APD421 (Drug)
结局指标
主要结局
Complete Response
时间窗: 24 hours after cisplatin dosing
No emesis or use of rescue medication
次要结局
未报告次要终点
研究者
研究点 (4)
Loading locations...
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