Phase II Proof-of-concept Study of APD421

NCT01303978 | Completed Phase 2

• 1 other identifier: DN10007
• Study Type: interventional
• Target: 51
• Locations: 2 countries
• Sites: 4

Brief Summary

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

Conditions

Chemotherapy-induced Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• Complete Response

  No emesis or use of rescue medication

  24 hours after cisplatin dosing

Study Arms (1)

APD421 starting dose

EXPERIMENTAL

Drug: APD421

Interventions

APD421 DRUG

Single dose

APD421 starting dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Acacia Pharma Ltd: lead

Study Sites (4)

Herlev Hospital

Copenhagen, Denmark

Location

Rigshospitalet

Copenhagen, Denmark

Location

Odense University Hospital

Odense, Denmark

Location

University Hospital of South Manchester NHS Trust

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2011
• First Posted: February 25, 2011
• Study Start: February 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: September 25, 2012

Record last verified: 2012-09

Locations

GB (1); DK (3)