Using Akynzeo to prevent nausea in endometrial cancer patients undergoing chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of a combination antiemetic drug, netupitant and palonsetron, in preventing chemotherapy-induced nausea and vomiting (CINV) in patients with endometrial cancer who are starting their first chemotherapy regimen. Participants will take a single dose of the drug before each chemotherapy cycle and will monitor their symptoms through questionnaires and diaries. The study aims to assess the drug's ability to reduce the occurrence of vomiting and nausea within 120 hours after the first cycle of treatment. It is a phase IV, multicentric, single-arm study focusing on chemo-naive patients receiving a taxane-platinum combination with or without immunotherapy.

Why it matters

Who can join: the full rules

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)

Where it's running

• ASST Lecco - A. Manzoni Hospital
  Lecco, Lc, Italy Recruiting
• Istituto Oncologico Veneto
  Padova, Pd, Italy Recruiting
• Fondazione IRCCS Istituto Nazionale dei Tumori
  Milan, Italy Recruiting
• ASST Spedali Civili di Brescia
  Brescia, Bs, Italy Not yet recruiting
• Centro di Riferimento Oncologico (CRO) IRCCS
  Aviano, Pn, Italy Not yet recruiting
• Azienda Ospedaliera Ordine Mauriziano di Torino
  Torino, To, Italy Active not recruiting

Study contacts

• Principal investigator: Monika Ducceschi, MD — Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Study coordinator: Monika Ducceschi, MD
• Email: monika.ducceschi@istitutotumori.mi.it
• Phone: +39 02 2390 2342

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.