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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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 4.
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