Akynzeo as Antiemetic Treatment in Patients With Endometrial Cancer

NCT06726291 | Recruiting Phase 4

• 2 other identifiers: INT 121-23 NOEME2023-504150-35-00
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 8

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).

Conditions

Endometrial Cancer

Keywords

antiemetic; nausea; vomiting; chemotherapy side effects; netupitant/palonosetron

Outcome Measures

Primary Outcomes (1)

• Effectiveness

  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

  overall phase (0-120 hours after NEPA administration) at cycle 1

Secondary Outcomes (5)

• Effectiveness

  acute (0-24 hours), delayed (>24 to 120 hours), and overall (0-120 hours) phases after the start of chemotherapy of each cycle

• Effectiveness

  acute (0-24 hours), delayed (>24 to 120 hours), and overall (0-120 hours) after the start of chemotherapy of each cycle

• Effectiveness

  acute (0-24 hours), delayed (>24 to 120 hours), and overall (0-120 hours) phases after the start of each cycle

• Safety

  From cycle 1 to cycle 4 of the treatment

• Quality of Life

  during each cycle of treatment

Study Arms (1)

antiemetic

EXPERIMENTAL

Patients who will receive a fixed dose combination of netupitant and palonsetron, NEPA

Drug: NEPA (300mg netupitant/0.5mg palonosetron)

Interventions

NEPA (300mg netupitant/0.5mg palonosetron) DRUG

a single dose (capsule) of NEPA (300mg netupitant/0.5 palonosetron) at day 1 for a maximum of 4 cycles

antiemetic

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study will enroll female patients ≥18 years of age with histologically or cytologically confirmed diagnosis of endometrial cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Study Sites (8)

ASST Spedali Civili di Brescia

Brescia, BS, 25123, Italy

NOT YET RECRUITING

ASST Lecco - A. Manzoni Hospital

Lecco, LC, 23900, Italy

RECRUITING

Istituto Oncologico Veneto

Padua, PD, 35128, Italy

RECRUITING

Centro di Riferimento Oncologico (CRO) IRCCS

Aviano, PN, 33081, Italy

NOT YET RECRUITING

Azienda Ospedaliera Ordine Mauriziano di Torino

Torino, TO, 10128, Italy

ACTIVE NOT RECRUITING

AOU Città della Salute e della Scienza di Torino

Torino, TO, 20126, Italy

NOT YET RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

RECRUITING

Istituto Europeo di Oncologia

Milan, 20141, Italy

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms; Nausea; Vomiting

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Monika Ducceschi, MD

  Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monika Ducceschi, MD

CONTACT

+39 02 2390 2342; monika.ducceschi@istitutotumori.mi.it

Mara Mantiero, MD

CONTACT

+39 02 2390 2342; mara.mantiero@istitutotumori.mi.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a phase IV, multicentric, single arm study, using a fixed dose combination of netupitant and palonsetron in the treatment of chemo-naive patients ≥18 years of age with histologically or cytologically confirmed diagnosis of endometrial cancer who will receive a single line of taxane-platinum combination with or without immunotherapy.

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: December 10, 2024
• Study Start: February 26, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 10, 2024

Record last verified: 2024-11

Locations

IT (8)