NCT06726291 Akynzeo as Antiemetic Treatment in Patients With Endometrial Cancer
| NCT ID | NCT06726291 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
| Condition | Endometrial Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2024-02-26 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 84 participants in total. It began in 2024-02-26 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Patients are considered to not be of child-bearing potential if they have a history of tubal ligation or hysterectomy or are post-menopausal with a minimum of 1 year without menses. Patients of child-bearing potential must agree to adequate birth control if conception is possible during the study and for 6 months after the last dose; in this case, patients must take a monthly pregnancy test for the duration of the study Exclusion Criteria: * They will experience emesis within the 24 hours before receipt of 1 course of chemotherapy * will be scheduled to radiation therapy to the abdomen or pelvis within 1 week before day 1 or between day 1 and 5 * Will be scheduled to undergo bone marrow or stem-cell transplant * Chronic systemic corticosteroid use * Brain metastasis * Subject is considered a poor medical risk due to a serious, uncontrolled medical disorder * History or predisposition to cardiac conduction abnormalities, torsade des pointes or severe cardiovascular diseases * Subject is pregnant or breastfeeding or is expecting to conceive children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of study treatment * They have any known hypersensitivity or contraindication to the components of the study drugs (hypersensitivity to the active substance or to any of the excipients contained in the product, as listed in the relevant section of the summary of product characteristics)
Contact & Investigator
Monika Ducceschi, MD
PRINCIPAL INVESTIGATOR
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Frequently Asked Questions
Who can join the NCT06726291 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Endometrial Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06726291 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06726291 currently recruiting?
Yes, NCT06726291 is actively recruiting participants. Contact the research team at monika.ducceschi@istitutotumori.mi.it for enrollment information.
Where is the NCT06726291 trial being conducted?
This trial is being conducted at Brescia, Italy, Lecco, Italy, Padova, Italy, Aviano, Italy and 4 additional locations.
Who is sponsoring the NCT06726291 clinical trial?
NCT06726291 is sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano. The principal investigator is Monika Ducceschi, MD at Fondazione IRCCS Istituto Nazionale dei Tumori, Milano. The trial plans to enroll 84 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.