EUCTR2010-022170-14-GB进行中（未招募）不适用
Open-label, ascending-dose, Phase II study to determine the minimum effective dose of APD421 (intravenous amisulpride) in the prevention of cisplatin-induced nausea and vomiting - Phase II proof-of-concept study of APD421
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
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
- •1.Male or female patients = 18 years of age.
- •2.Ability and willingness to give written informed consent.
- •3.Patients scheduled to receive, on day 1 of their chemotherapy, a first cisplatin chemotherapy infusion at a dose of 50 mg/m2 or greater.
- •4.Karnofsky performance score = 60%.
- •5.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.
- •6.Adequate haematological function
- •Haemoglobin = 9 g/dL
- •White blood count = 3.0 x 109/L
- •Platelet count = 100 x 109/L
- •7.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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Patients scheduled to receive, prior to or in the 24 hours after cisplatin, any chemotherapeutic agent with a high or moderate emetic risk according to published criteria.
- •2.Patients scheduled to receive paclitaxel or docetaxel.
- •3.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.
- •4.Patients receiving amisulpride for any indication within the last 2 weeks.
- •5.Patients who are allergic to amisulpride or any of the excipients of APD421.
- •6.Patients with a pre-existing vestibular disorder.
- •7.Patients being treated with regular anti-emetic therapy including corticosteroids.
- •8.Patients receiving inhaled corticosteroids, unless started more than one month prior to the expected date of study entry.
- •9.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.
- •10.Patients being treated with levodopa.
- •11.Patients receiving benzodiazepines, unless on a stable dose for at least one month prior to the expected date of study entry.
- •12.Patients with pre-existing nausea or vomiting in the 24 hours before receiving cisplatin chemotherapy, e.g. anticipatory emesis.
- •13.Patients who are pregnant or breast feeding.
- •14.Patients with a history of alcohol abuse.
- •15.Patients with pre-existing, clinically significant cardiac arrhythmia.
- •16.Any other concurrent disease or illness that, in the opinion of the investigator makes the patient unsuitable for the study.
- •17.Patients who have participated in another study within the previous 28 days.
- •18.Patients who are allergic to ondansetron or who would otherwise be considered inappropriate to receive ondansetron.
研究者
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