Phase II Proof-of-concept Study of APD421

Chemotherapy-induced Nausea and Vomiting Clinical Trial

Official title:

Open-label, Ascending-dose, Phase II Study to Determine the Minimum Effective Dose of APD421 in the Prevention of Cisplatin-induced Nausea and Vomiting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01303978
• Other study ID #: DN10007
• Status: Completed
• Phase: Phase 2
• First received: February 24, 2011
• Last updated: September 21, 2012
• Start date: February 2011
• Est. completion date: July 2012

Study information

• Verified date: September 2012
• Source: Acacia Pharma Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

Evaluation of efficacy of APD421 in preventing nausea and vomiting caused by cisplatin

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chemotherapy-induced Nausea and Vomiting
• Vomiting

Intervention

Drug:
• APD421
Single dose

Locations

Country	Name	City	State
Denmark	Herlev Hospital	Copenhagen
Denmark	Rigshospitalet	Copenhagen
Denmark	Odense University Hospital	Odense
United Kingdom	University Hospital of South Manchester NHS Trust	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Acacia Pharma Ltd

Countries where clinical trial is conducted

Denmark,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Response	No emesis or use of rescue medication	24 hours after cisplatin dosing	No