Phase II dose-finding study of APD403 in CINV
Research type
Research Study
Full title
Randomised, double-blind, dose-finding Phase II study to assess the efficacy of APD403 in the prevention of nausea and vomiting caused by cisplatin- or anthracycline/ cyclophosphamide (AC)-based chemotherapy
IRAS ID
130170
Contact name
Research and Development Directorate Ground Floor, Education and Research Centre
Contact email
Eudract number
2013-001635-51
Clinicaltrials.gov Identifier
Research summary
This study aims to find out how effective the drug APD403 is at preventing sickness in cancer patients receiving either cisplatin or anthracycline-cyclophosphamide (AC) chemotherapy. These are effective treatments for cancers such as lung and breast cancer, but they cause a very high rate of nausea (feeling sick) and vomiting (being sick). This is known as chemotherapy-induced nausea and vomiting (CINV). CINV occurs in two distinct phases: on the day of chemotherapy (known as “acute phase“) and over the following 4 days (“delayed phase“). Without anti-sickness drugs, almost everyone who gets cisplatin or AC will get CINV. A number of anti-sickness drugs (anti-emetics) are available and although they are good at preventing CINV in the acute phase, they are not as good in the delayed phase. There is therefore a need for new and better anti-emetics especially to prevent delayed phase CINV. This study will look at 3 different doses of APD403 to see how effective they are at preventing CINV, compared to a placebo treatment, and how the effectiveness varies with dose, if at all. In addition to each active dose group and the placebo group, there will be a fifth group, the control group, given the currently recommended combination of three preventive anti-emetics. Around 70 patients will be enrolled in each group, over a period of about 8 months. Episodes of sickness will be recorded for each patient for the 5 day (120 hour) period starting from the chemotherapy treatment.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
13/NW/0462
Date of REC Opinion
3 Jul 2013
REC opinion
Favourable Opinion