Actively Recruiting
Akynzeo as Antiemetic Treatment in Patients With Endometrial Cancer
Led by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Updated on 2024-12-10
84
Participants Needed
8
Research Sites
122 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Akynzeo as Antiemetic Treatment in Patients With Endometrial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 years or older
- Histologically or cytologically confirmed diagnosis of endometrial cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Adequate organ function to receive taxane-platinum chemotherapy with or without immunotherapy
- Chemotherapy-naive patients
- Women of child-bearing potential must have a negative pregnancy test and agree to use adequate birth control during the study and for 6 months after the last dose
- Permanent sterilization or post-menopausal status with at least 1 year without menses exempts from birth control requirements
You will not qualify if you...
- Vomiting within 24 hours before starting chemotherapy
- Scheduled radiation therapy to the abdomen or pelvis within 1 week before or between days 1 to 5 of chemotherapy
- Planned bone marrow or stem-cell transplant
- Chronic systemic corticosteroid use
- Presence of brain metastasis
- Serious uncontrolled medical disorders posing poor medical risk
- History or risk of cardiac conduction abnormalities, torsade de pointes, or severe cardiovascular diseases
- Pregnancy, breastfeeding, or planned pregnancy during the study and up to 180 days after last dose
- Known allergy or contraindication to study drug components
AI-Screening
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Trial Site Locations
Total: 8 locations
1
ASST Spedali Civili di Brescia
Brescia, BS, Italy, 25123
Not Yet Recruiting
2
ASST Lecco - A. Manzoni Hospital
Lecco, LC, Italy, 23900
Actively Recruiting
3
Istituto Oncologico Veneto
Padova, PD, Italy, 35128
Actively Recruiting
4
Centro di Riferimento Oncologico (CRO) IRCCS
Aviano, PN, Italy, 33081
Not Yet Recruiting
5
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino, TO, Italy, 10128
Active, Not Recruiting
6
AOU Città della Salute e della Scienza di Torino
Torino, TO, Italy, 20126
Not Yet Recruiting
7
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133
Actively Recruiting
8
Istituto Europeo di Oncologia
Milan, Italy, 20141
Active, Not Recruiting
Research Team
M
Monika Ducceschi, MD
CONTACT
M
Mara Mantiero, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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