Akynzeo as Antiemetic Treatment in Patients With Endometrial Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
NEPA (300mg netupitant/0.5mg palonosetron): a single dose (capsule) of NEPA (300mg netupitant/0.5 palonosetron) at day 1 for a maximum of 4 cycles
Study summary
The clinical trial concerns the use of an innovative \"anti-emetic\" drug (that is, anti-vomiting and nausea) in subjects affected by endometrial cancer. It is addressed to patients who have never received chemotherapy before and are about to start a treatment with platinum and taxanes with or without immunotherapy for endometrial cancer.
The primary objective of the study is to learn if the drug is able to avoid the occurrence of vomiting and post- nausea chemotherapy within 120 hours after cycle 1 with carboplatin and paclitaxel with or without immunotherapy.
Partecipants will take the drug before the chemotherapy/immunotherapy (single dose at day one of each cycle of therapy, that is one capsule before treatment). The entire duration of participation in the study may extend to the fourth cycle of chemotherapy/immunotherapy.
Patients will fill in questionnaires and keep a diary of the number and intensity of symptoms (vomiting and nausea).
Eligibility
Primary outcome measure(s)
- Effectiveness — overall phase (0-120 hours after NEPA administration) at cycle 1
Evaluate effectiveness of a single oral dose of NEPA in terms of complete response (CR: no emesis, no rescue medication) in the overall phase (0-120h) at cycle 1 in chemotherapy-naïve patients with endometrial cancer receiving paclitaxel and carboplatin chemotherapy with or without immunotherapy
Trial sites (8)
| Facility | City | Region | Status |
|---|---|---|---|
| ASST Spedali Civili di Brescia | Brescia | BS | Not Yet Recruiting |
| ASST Lecco - A. Manzoni Hospital | Lecco | LC | Recruiting |
| Istituto Oncologico Veneto | Padova | PD | Recruiting |
| Centro di Riferimento Oncologico (CRO) IRCCS | Aviano | PN | Not Yet Recruiting |
| Azienda Ospedaliera Ordine Mauriziano di Torino | Torino | TO | Active Not Recruiting |
| AOU Città della Salute e della Scienza di Torino | Torino | TO | Not Yet Recruiting |
| Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | Italy | Recruiting |
| Istituto Europeo di Oncologia | Milan | Italy | Active Not Recruiting |
More Fondazione IRCCS Istituto Nazionale dei Tumori, Milano trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06726291 on ClinicalTrials.gov ↗ ← All trials in Italy