EUCTR2013-001635-51-DK进行中（未招募）1 期
Randomised, double-blind, dose-finding Phase II study to assess the efficacy of APD403 in the prevention of nausea and vomiting caused by cisplatin- or anthracycline/ cyclophosphamide (AC)-based chemotherapy - Phase II dose-finding study of APD403 in CINV
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 315
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, either: (i) a first cisplatin chemotherapy infusion at a dose of =70 mg/m2 (males and females); or (ii) a first infusion of cyclophosphamide at a dose of 500-1500 mg/m2 in combination with either epirubicin at a dose of 60-100 mg/m2 or doxorubicin at a dose of 40-60 mg/m2 (females only)
- •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 < 5 x ULN
- •Creatinine < 3 x ULN
- •6.Adequate haematological function
- •Haemoglobin = 8 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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 115
排除标准
- •1.Patients scheduled to receive, prior to or in the 24 hours after cisplatin or AC, any other chemotherapeutic agent with a high or moderate emetic risk
- •2.Patients who have previously received anti-neoplastic chemotherapy
- •3.Patients scheduled to receive paclitaxel or docetaxel during the first cycle of their chemotherapy
- •4.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 or AC administration
- •5.Patients with a known prolactin-dependent tumour (e.g. pituitary gland prolactinoma or confirmed prolactin-dependent breast cancer) or phaeochromocytoma
- •6.Patients receiving amisulpride for any indication within the last 2 weeks
- •7.Patients who are allergic to amisulpride or any of the excipients of APD421; or to ondansetron, fosaprepitant or dexamethasone; or who would be otherwise considered inappropriate for treatment with any of those agents
- •8.Patients with a pre-existing vestibular disorder
- •9.Patients being treated with regular anti-emetic therapy including corticosteroids
- •10.Patients receiving inhaled corticosteroids, unless started more than one month prior to the expected date of study entry
- •11.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
- •12.Patients being treated with levodopa
- •13.Patients receiving benzodiazepines, unless on a stable dose for at least one month prior to the expected date of study entry
- •14.Patients with pre-existing nausea or vomiting in the 24 hours before receiving chemotherapy
- •15.Patients who are pregnant or breast feeding
- •16.Patients with a history of alcohol abuse
- •17.Patients with any pre-existing, clinically significant cardiac arrhythmia
- •18.Any other concurrent disease or illness that, in the opinion of the investigator makes the patient unsuitable for the study
- •19.Patients who have participated in another therapeutic study within the previous 28 days
研究者
相似试验
进行中（未招募）
1 期
Study of APD403 in the prevention of sickness caused by some chemotherapy drugsEUCTR2013-001635-51-GBAcacia Pharma Ltd328
进行中（未招募）
1 期
Study of APD403 in the prevention of sickness caused by some chemotherapy drugsEUCTR2013-001635-51-DEAcacia Pharma Ltd315
进行中（未招募）
1 期
A randomized phase 2 study to determine the dose, and assessthe efficacy, safety, and tolerability of Gemcabene in Patients withHypercholesterolemia.HypercholesterolaemiaMedDRA version: 19.0Level: PTClassification code 10020603Term: HypercholesterolaemiaSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2015-005756-10-DKGemphire Therapeutics Inc.212
未知
2 期
Phase 2 Dose-finding, Double-blind Controlled Study of SFPP in Knee Osteoarthritis 2ndJPRN-jRCT2080220876Taisho Pharmaceutical co., LTD500
进行中（未招募）
1 期
Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative ColitisModerate to Severe Active Ulcerative ColitisMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856EUCTR2021-002537-41-ITAMGEN INC.320