Phase II Proof-of-concept Study of APD421
Study Details
Study Description
Brief Summary
Evaluation of efficacy of APD421 in preventing nausea and vomiting caused by cisplatin
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: APD421 starting dose
|
Drug: APD421
Single dose
|
Outcome Measures
Primary Outcome Measures
- Complete Response [24 hours after cisplatin dosing]
No emesis or use of rescue medication
Eligibility Criteria
Criteria
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, 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.
Exclusion Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Herlev Hospital | Copenhagen | Denmark | ||
| 2 | Rigshospitalet | Copenhagen | Denmark | ||
| 3 | Odense University Hospital | Odense | Denmark | ||
| 4 | University Hospital of South Manchester NHS Trust | Manchester | United Kingdom |
Sponsors and Collaborators
- Acacia Pharma Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DN10007