Akynzeo as Antiemetic Treatment in Patients With Endometrial Cancer
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 immunothe
| Condition(s) | Endometrial Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| 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 t |
| Who can participate | Inclusion Criteria: * Subject is at least 18 years of age, able to understand the study procedures, and agrees to participate in the study by providing written informed consent * Subject has histologically or cytologically proven endometrial cancer * Patients were required to have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 * Adequate organ function allowing the patient to receive taxane-platinum combination therapy with or without immunotherapy according to clinical practice and opinion of treating physician * Naive to chemotherapy * Women of child-bearing potential must have a negative pregnancy test (urine). Female patients are considered of child-bearing potential following menarche and until becoming post-menopausal unless permanently sterile. Permanen |
| Ages | 18 Years |
| Sex | Female |
| Lead sponsor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
| Locations | Brescia, BS, Italy; Lecco, LC, Italy; Padova, PD, Italy; Aviano, PN, Italy; Torino, TO, Italy; Torino, TO, Italy (+2 more sites) |
| Start date | 2024-02-26 |
| NCT ID | NCT06726291 |
| Official listing | https://clinicaltrials.gov/study/NCT06726291 |