NCT06726291RecruitingPhase 4
Akynzeo as Antiemetic Treatment in Patients With Endometrial Cancer
Akynzeo as Antiemetic Treatment in Patients With Endometrial Cancer Treated With Taxane- Platinum Combination Chemotherapy. NOEME Study.
Source: ClinicalTrials.gov · Last updated 10 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- First submitted
- 25 Nov 2024
- Start date
- 26 Feb 2024
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Diseases
- Endometrial cancer
- NCT number
- NCT06726291
- EU CT number
- 2023-504150-35-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 84
- From 26 Feb 2024 to the primary completion date, 31 Dec 2025
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
- 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)
Other
- Brain metastasis
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro di Riferimento Oncologico di Aviano Coordinator of this site? Confirm its status | Aviano | Italy | Recruiting |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Recruiting |
| Alessandro Manzoni Hospital Coordinator of this site? Confirm its status | Lecco | Italy | Recruiting |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| European Institute Of Oncology S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Istituto Oncologico Veneto Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
| Azienda Ospedaliera Ordine Mauriziano di Torino Coordinator of this site? Confirm its status | Turin | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino Coordinator of this site? Confirm its status | Turin | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.