Bioanalytical
New study aims to reduce CINV in cancer patients
Oct 30 2013
A new Phase II study has been launched to test whether APD403 successfully helps to minimise nausea and vomiting within patients that are undergoing chemotherapy. The study, being run by Acacia Pharma, which specialises in supportive care medication, will look at whether the drug helps to reduce chemotherapy-induced nausea and vomiting (CINV) in patients, which can make cancer treatment more bearable.
Around 70 per cent of all cancer patients receiving chemotherapy experience CINV. This goes up to 90 per cent of patients when they are being treated with highly emetogenic chemotherapy (HEC). The treatment can result in two forms of the condition, acute CINV occurs on the same day as treatment, while delayed CINV can affect a patient up to five days after treatment.
For patients who undergo chemotherapy for the treatment of cancer, CINV is an unneeded extra weight on their shoulders and, although management of CINV has come a long way, more still needs to be done to improve quality of life throughout treatment.
Dr Julian Gilbert, chief executive of Acacia Pharma, said: "CINV is an incredibly debilitating condition. Although significant advances have been made in the management of vomiting, nausea remains a major issue. We believe APD403 is a good anti-vomiting agent and an excellent anti-nauseant, thereby having the potential to make a significant contribution to cancer care."
The study is taking place in centres throughout Denmark, the US, Germany and the UK. Around 315 patients that are receiving HEC as part of the cancer treatment are to be recruited. Participants will receive three doses of the APD403 treatment during the phase that delayed CINV will usually affect people, which will be measured against a placebo to assess its effectiveness.
It is hoped that the drug will result in patients not experiencing any vomiting or retching for the five days following chemotherapy treatment. The study will also monitor the feeling of nausea experienced by participants, although this is to be the second endpoint of the study.
Dr Gabriel Fox, chief medical officer for Acacia Pharma, said: "We are delighted to be working with an outstanding international group of investigators, including some of the world's leading authorities on CINV. Our clinical sites are highly enthusiastic about investigating this promising potential addition to the anti-emetic armamentarium."
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