Trial Information

Summary: A PivotalPhase 3 Observer-Blind, Randomized Clinical Trial of the Efficacy and Safety of AP530 Compared to Aloxi^R for the Prevention of Acute-Onset and Delayed-Onset Chemotherapy-Induced Nausea and Vomiting Following the Administration of Either Moderately or Highly Emetogenic Chemotherapy Regimens. C2006-01

Inclusion Criteria:

• Subjects will be male or non pregnant female who are 18 years of age or older.
• Subjects must have histologically or cytologically confirmed malignant disease.
• Subjects must be undergoing treatment with a moderately or highly emetogenic chemotherapy regiment (causing nausea and vomiting in 30% to 100% if untreated)
• Subjects must be able to receive standard doses of dexamethasone as prescribed in the protocol, for the prevention of emesis.
• Subjects must be characterized as having EGOC performance status 0,1, or 2.
• Subjects will be willing and able to comply with all testing and requirements defined in the protocol.
• Subjects must be able to provide voluntary written informed consent.
• Adequate protection from conception both female subjects and female partners of male subjects during treatment and up to one year later.

Exclusion Criteria:

• Subjects who have received radiation therapy in the 7 days preceding the study medication or if they are to receive radiation within five days of study medication.
• Subjects who have received chemotherapy in the 7 days preceding the receipt of study medication.
• Subjects who received anti-nausea medication in the 7 days preceding the receipt of study medication.
• Subjects who have a hypersensitivity to other selective 5-HT₃ receptor antagonists or local anesthetics.
• Subjects receiving coticosteriods other than dexamethasone, or doses of dexamethasone other than prescribed in the protocol.
• Subjects who have head and neck or upper GI cancer.
• Pyschological problems that may preclude study participation.
• A recent history of (1 year) of alcohol or drug abuse.
• Greater than mild nausea and vomiting within 24 hours of receiving study med on the first cycle.
• Pregnancy or breast feeding.
• Use of an investigational drug within 30 days of study entry.
• Certain EKG changes or cardiac arrhythmia.
• Use of any prohibited med per study within 7 days of study drug administration.

For more information,

If you would like to learn more about participating in this study, please send an e-mail message using the form below.