Endometrial CancerPhase 4NOEMENCT06726291
Akynzeo as Antiemetic Treatment in Patients With Endometrial Cancer
A Phase 4 study testing NEPA (300mg netupitant/0.5mg palonosetron) in people with Endometrial Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 8 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- NEPA (300mg netupitant/0.5mg palonosetron)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 8 sitesItaly
- Study dates
- 26 Feb 2024to 30 Jun 2026
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Italy8 sites, 6 recruiting
- Not yet recruiting
Centro di Riferimento Oncologico (CRO) IRCCS
Aviano, PN, 33081
Michele Bartoletti, MD, +39 0434 659139, michele.bartoletti@cro.it
Michele Bartoletti, MD
- Not yet recruiting
ASST Spedali Civili di Brescia
Brescia, BS, 25123
Germana Tognon, MD, +39 030 399842, germanatognon@gmail.com
Germana Tognon, MD
- Recruiting
ASST Lecco - A. Manzoni Hospital
Lecco, LC, 23900
Alessandra Crippa, MD, +39 0341 489902, a.crippa@asst-lecco.it
Alessandra Crippa, MD
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
Monika Ducceschi, MD, +39 02 2390 2342, monika.ducceschi@istitutotumori.mi.it
Mara Mantiero, MD, +39 02 2390 2342, mara.mantiero@istitutotumori.mi.it
- Active, not recruiting
Istituto Europeo di Oncologia
Milan, 20141
- Recruiting
Istituto Oncologico Veneto
Padova, PD, 35128
Giulia Tasca, MD, +39 049 8215931, giulia.tasca@iov.veneto.it
Giulia Tasca, MD
- Active, not recruiting
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino, TO, 10128
- Not yet recruiting
AOU Città della Salute e della Scienza di Torino
Torino, TO, 20126
Dionnyssios Katsaros, MD, +39 011 3131916, d.katsaros@libero.it
Dionnyssios Katsaros, MD
About this study
Official title: Akynzeo as Antiemetic Treatment in Patients With Endometrial Cancer Treated With Taxane- Platinum Combination Chemotherapy. NOEME Study.
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.
Read more
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).
Read the detailed description
Chemotherapy side effects (CSE) have a considerable impact on quality of life and can severely impair a patient's ability to manage daily activities and employment. Moreover, unsatisfactory control of chemotherapy toxicities affecting treatment effectiveness necessitates dose reduction and/or treatment deferral. Measures to reduce CSEs, such as antiemetic drugs and other supportive agents, are often prescribed during treatment cycles.
CINV (chemotherapy-induced nausea and vomiting) is the most dreaded side effect before starting chemotherapy in both genders and across all age classes, and women are significantly more concerned about it than men. Patients with gynecological cancer represent an extremely challenging population in which to treat or control CINV. Indeed, female sex is associated with a higher risk of CINV. In addition, gynecological malignancies often disseminate in the abdomen, increasing the emetogenic potential of chemotherapies. Thus, these patients are at a relatively high risk of experiencing CINV.
This is a phase IV, multicentric, single arm study using a fixed dose combination of netupitant and palonsetron NEPA 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.
This study aims also to evaluate patients' expectation and perception of CINV and other chemotherapy side effects (CSEs); impact of CINV and others CSEs on quality of life, health, family and personal relationships, daily activities and employment in patients with endometrial cancer receiving paclitaxel and carboplatin regimen. The agreement between patients' assessment of CINV and other CSEs as reported in a self-report scale and what they referred to clinicians about nausea and CSEs at the following chemotherapy cycle and agreement between patients' expectation of CINV and other CSEs before initiating of chemotherapy and the side effects that they actually experienced during chemotherapy will be also evaluated.
Patients will be observed over a duration of 4 cycles. The primary endpoint will be assessed at cycle 1.
This study will enroll female patients ≥18 years of age with histologically or cytologically confirmed diagnosis of endometrial cancer who will receive a single line of taxane-platinum combination therapy with or without immunotherapy. This includes chemotherapy naïve patients who will receive taxane-platinum combination therapy in adjuvant setting or chemotherapy naïve patients who will receive first line taxane-platinum combination therapy with or without immunotherapy for primary advanced or recurrent disease. The planned number of patients is 84, and 8 centers will be involved in the trial.
Primary objective: To 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 with or without immunotherapy.
- Conditions
- Endometrial Cancer
- Being tested
- NEPA (300mg netupitant/0.5mg palonosetron)
- Keywords
- antiemetic, nausea, vomiting, chemotherapy side effects, netupitant/palonosetron
- Medical subject headings
- Endometrial Neoplasms, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| antiemetic | Experimental | Patients who will receive a fixed dose combination of netupitant and palonsetron, NEPA Receives: Drug: NEPA (300mg netupitant/0.5mg palonosetron) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: overall phase (0-120 hours after NEPA administration) at cycle 1
Secondary outcomes (5)
Effectiveness
Effectiveness of a single oral dose of NEPA in terms of CR and complete control (CC: no rescue medication, no emesis and no nausea (VAS score of \<25 mm) during the acute (0-24 hours), delayed (\>24 to 120 hours), and overall (0-120 hours) phases after the start of chemotherapy of each cycle
Measured: acute (0-24 hours), delayed (>24 to 120 hours), and overall (0-120 hours) phases after the start of chemotherapy of each cycle
Effectiveness
Effectiveness of a single dose of NEPA in terms of no rescue medication, no emesis and no significant nausea (VAS score of \<25 mm) during the acute (0-24 hours), delayed (\>24 to 120 hours), and overall (0-120 hours) after the start of chemotherapy of each cycle
Measured: acute (0-24 hours), delayed (>24 to 120 hours), and overall (0-120 hours) after the start of chemotherapy of each cycle
Effectiveness
Effectiveness of a single oral dose of NEPA in terms of CR and complete control during the acute (0-24 hours), delayed (\>24 to 120 hours), and overall (0-120 hours) phases after the start of each cycle according to Patient Emetogenicity Risk Profile assessed with CINV Risk Assessment tool
Measured: acute (0-24 hours), delayed (>24 to 120 hours), and overall (0-120 hours) phases after the start of each cycle
Safety
Evaluate safety of NEPA when given in multiple treatment cycles in patients with endometrial cancer receiving paclitaxel and carboplatin regimen with or without immunotherapy
Measured: From cycle 1 to cycle 4 of the treatment
Quality of Life
Evaluate QoL of patients with endometrial cancer treated with paclitaxel and carboplatin regimen receiving NEPA as antiemetic treatment in terms of FLIE scores during each cycle.
This study aims also to evaluate patients' expectation and perception of CINV and other chemotherapy side effects (CSEs); impact of CINV and others CSEs on quality of life, health, family and personal relationships, daily activities and employment in patients with endometrial cancer receiving paclitaxel and carboplatin regimen. The agreement between patients' assessment of CINV and other CSEs as reported in a self-report scale and what they referred to clinicians about nausea and CSEs at the following chemotherapy cycle and agreement between patients' expectation of CINV and other CSEs before initiating of chemotherapy and the side effects that they actually experienced during chemotherapy will be also evaluated.
Measured: during each cycle of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start26 Feb 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Monika Ducceschi, MD, Principal investigator, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726291
- Sponsor's protocol ID
- INT 121-23 NOEME
- Other IDs
- 2023-504150-35-00, 2023
- Acronym
- NOEME
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No