- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01303978
Phase II Proof-of-concept Study of APD421
September 21, 2012 updated by: Acacia Pharma Ltd
Open-label, Ascending-dose, Phase II Study to Determine the Minimum Effective Dose of APD421 in the Prevention of Cisplatin-induced Nausea and Vomiting
Evaluation of efficacy of APD421 in preventing nausea and vomiting caused by cisplatin
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Copenhagen, Denmark
- Rigshospitalet
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Copenhagen, Denmark
- Herlev Hospital
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Odense, Denmark
- Odense University Hospital
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Manchester, United Kingdom
- University Hospital of South Manchester NHS trust
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: APD421 starting dose
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Single dose
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete Response
Time Frame: 24 hours after cisplatin dosing
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No emesis or use of rescue medication
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24 hours after cisplatin dosing
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Actual)
July 1, 2012
Study Completion (Actual)
July 1, 2012
Study Registration Dates
First Submitted
February 24, 2011
First Submitted That Met QC Criteria
February 24, 2011
First Posted (Estimate)
February 25, 2011
Study Record Updates
Last Update Posted (Estimate)
September 25, 2012
Last Update Submitted That Met QC Criteria
September 21, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DN10007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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