Chemotherapy-induced Nausea and Vomiting
Conditions
Brief summary
Evaluation of efficacy of APD421 in preventing nausea and vomiting caused by cisplatin
Interventions
DRUGAPD421
Single dose
Sponsors
Acacia Pharma Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 \< 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.
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, see Appendix 4. 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 APD421 for any indication within the last 2 weeks 5. Patients who are allergic to APD421 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 xxx 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response | 24 hours after cisplatin dosing | No emesis or use of rescue medication |
Countries
Denmark, United Kingdom
Outcome results
None listed