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Clinical Trials

Date: 2011-02-16

Type of information:

phase: 2a

Announcement: initiation of the dose-escalating, Phase IIa proof-of-concept study

Company: Acacia Pharma (UK)

Product: APD421 (intravenous formulation of a currently marketed dopamine D2 antagonist for the new use of prevention and treatment of nausea & vomiting.)

Action mechanism:

Disease: chemotherapy-induced nausea & vomiting (CINV) and post-operative nausea and vomiting (PONV)

Therapeutic area: Cancer - Oncology - CNS diseases

Country: Denmark, UK

Trial details: The single ascending dose study is taking place in four hospitals in Denmark and the UK, and will enrol up to 54 cancer patients receiving the highly emetogenic chemotherapy drug cisplatin. The primary endpoint will be protection from vomiting and no requirement for anti-emetic rescue medication during the first 24 hours after dosing with cisplatin. Upon successful completion of this proof-of-concept study, Acacia Pharma will proceed to a dose-ranging study of APD421 in adult surgical patients.

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Is general: Yes