Phase II proof-of-concept study of APD421

• Research type

  Research Study

• Full title

  Open-label, ascending-dose, Phase II study to determine the minimum effective dose of APD421 (intravenous amisulpride) in the prevention of cisplatin-induced nausea and vomiting

• IRAS ID

  66636

• Contact name

  Yvonne Summers

• Sponsor organisation

  Acacia Pharma Ltd

• Eudract number

  2010-022170-14

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  This study aims to find out how effective the drug APD421 is at preventing sickness in cancer patients receiving cisplatin chemotherapy as treatment for their cancer. Cisplatin is an effective treatment for a number of types of cancer such as lung and bladder cancer but causes a very high rate of nausea (feeling sick) and vomiting (being sick). This is known as cisplatin-induced nausea and vomiting (CINV). Without anti-sickness drugs, almost everyone who gets cisplatin will get CINV. A number of anti-sickness drugs (anti-emetics) are available and they are effective at preventing CINV in half to three-quarters of patients receiving cisplatin. But there is a need for new and better anti-emetics to help more patients. The study will look at up to 3 or 4 different doses of APD421 to see if any is effective enough at preventing CINV. Between 5 and 18 patients will be enrolled at each dose level over a period of about 3-6 months. Each patient will be observed for 24 hours after receiving APD421 and cisplatin and any episodes of sickness will be recorded.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  10/H0304/91

• Date of REC Opinion

  14 Dec 2010

• REC opinion

  Further Information Favourable Opinion