This is a multicentre, single-arm, phase II study to investigate the safety and antiemetic
efficacy of Akynzeo (a fixed dose combination of palonosetron and netupitant) plus
dexamethasone in patients receiving concomitant chemo-radiotherapy with weekly cisplatin for
at least five weeks.
Akynzeo contains a combination of the neurokinin-1 receptor antagonist netupitant and the
serotonin receptor antagonist palonosetron. Akynzeo is approved as antiemetic prophylaxis in
patients receiving high emetogenic chemotherapy e.g. high dose cisplatin administered every
From a previous clinical trial (GAND-emesis trial) we know that patients receiving
radiotherapy and concomitant weekly cisplatin 40 mg/m2 are better protected against nausea
and vomiting when a triplet antiemetic prophylaxis (neurokinin-1 receptor antagonist,
serotonin receptor antagonist, and corticosteroid) is applied.
In the Akynzeo phase III clinical trials, Akynzeo was administered every three weeks. The
neurokinin-1 receptor antagonist, netupitant, has a long plasma half-life (approx. 90 hours),
and theoretically the drug could accumulate when administered on a weekly basis.
The DANGER-emesis trial is designed to collect safety and efficacy data in patients receiving
Akynzeo weekly as antiemetic prophylaxis in combination with dexamethasone in patients
treated for cervical cancer with radiotherapy and concomitant weekly cisplatin 40 mg/m2.
Chemotherapy-induced Nausea and Vomiting, Adverse Event, Cervical Cancer
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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