Cisplatin-induced nausea and vomiting MedDRA version: 14.0 Level: PT Classification code 10054133 Term: Prophylaxis of nausea and vomiting System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Sponsors
Acacia Pharma Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the lowest dose of APD421 which shows an adequate level of effectiveness at preventing sickness in patients given cisplatin chemotherapy (compared to what would be expected based on historical data on other known anti-emetics).;Secondary Objective: To quantify the severity and timescale of any sickness seen in patients given APD421 (at various doses) before cisplatin chemotherapy, and to assess the safety of APD421 at various doses.;Primary end point(s): The primary outcome measure is complete response, described as an absence of emetic episodes and no rescue medication use in the 24-hour period after the start of the cisplatin infusion. | — |
Countries
United Kingdom
Outcome results
None listed