Dose-finding Study of APD403 to Prevent Nausea and Vomiting After Chemotherapy

Inclusion criteria * 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, 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) * 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 \< 5 x ULN * Creatinine \< 3 x ULN * Adequate haematological function * Haemoglobin ≥ 8 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 Exclusion Criteria * Patients scheduled to receive, prior to or in the 120 hours after cisplatin or AC, any other chemotherapeutic agent with a high or moderate emetic risk * Patients who have previously received anti-neoplastic chemotherapy * Patients scheduled to receive paclitaxel or docetaxel during the first cycle of their chemotherapy * 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 * Patients with a known prolactin-dependent tumour (e.g. pituitary gland prolactinoma or confirmed prolactin-dependent breast cancer) or phaeochromocytoma * 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