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CO44195 - Studio a braccio singolo di fase II su Giredestrant in pazienti con carcinoma dell’endometrio di grado 1

Studio Clinico

Patologia: Tumori dell’utero

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: II

Linee di trattamento: Prima linea

Criteri di inclusione: 

- Confirmed Grade 1 endometrial cancer (EC) of endometrioid histology for which participants are willing to receive 6-cycles of study therapy. An endometrial biopsy (EMB) or dilation and curettage (D&C) sample must be provided within 2 months of enrollment to a central laboratory for histologic confirmation to determine eligibility.
- Life expectancy ≥12 weeks
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Magnetic resonance imaging (MRI)-confirmation of non-deeply invasive tumor
- MRI or computed tomography (CT)-confirmation of no extrauterine disease
- Willing to undergo a minimum of 6 continuous cycles of therapy before decision on surgery
- No prior treatment for complex endometrial hyperplasia (EH), endometrial intraepithelial neoplasia (EIN), or endometrial cancer
- Able and willing to take oral medications
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
- Adequate hematologic and end-organ function, as defined in the protocol
- Negative HIV test at screening
- For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agree to refrain from donating eggs, during the treatment period and for 10 days after the final dose of giredestrant, as defined in the protocol.

Criteri di esclusione: 

- Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 10 days after the final dose of giredestrant or within the time period specified per local prescribing guidelines after the final dose of the investigator's choice of endocrine therapy
- Participants with non-endometrioid histologies, such as serous, clear cell, and mixed
- Treatment with investigational therapy within 28 days prior to initiation of study enrollment
- Treatment for cancer including but not limited to, chemotherapy, immunotherapy, cyclin-dependent kinase (CDK)4/6 inhibitors, endocrine therapy, biologic therapy, or herbal therapy within 28 days prior to the initiation of study enrollment
- Any gastrointestinal condition causing malabsorption or obstruction (e.g., celiac sprue, gastric bypass surgery, strictures, adhesions, history of small bowel resection, blind loop syndrome)
- Has been on any hormonal treatment (including progestin-containing intrauterine device [IUD]) for complex atypical hyperplasia (CAH)/EIN or Grade 1 EC in the last 3 months
- Use hormone replacement therapy (including systemic or topical estrogen, progesterone, or testosterone based medication) or/and phytoestrogen supplements (i.e., black cohosh) or has been on progestin (including progestin-containing IUD), tamoxifen or aromatase inhibitor within the prior 3 months
- Known hypersensitivity to giredestrant or its excipients
- Known intercurrent illness or psychiatric illness/social situations that will limit compliance with study requirements
- Evidence or high suspicion of metastatic/extrauterine disease at enrollment
- Unwilling or unable to comply with study-related procedures, including all endometrial sampling/biopsies
- Planned surgery, either for the treatment of cancer or any other surgery, during the study treatment period and up to 9 days after the completion of study treatment
- Serious infections requiring IV antibiotics within 7 days prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact participant safety
- Participants who have clinically significant liver disease consistent with Child-Pugh Class B or C, including active hepatitis (e.g., hepatitis B virus [HBV] or hepatitis C virus [HCV]), current alcohol abuse, cirrhosis, or positive test for viral hepatitis, as defined in the protocol
- Substance abuse within 12 months prior to screening
- Any serious medical condition or abnormality in clinical laboratory tests that precludes the participant's safe participation in and completion of the study
- History of other malignancy within 5 years prior to screening, except for those with an expected negligible risk for metastases or death (e.g., 5-year overall survival 90%) after curative treatment
- Active tuberculosis
- Severe infection per investigator judgment at the time of enrollment, including but not limited to, use of systemic antibiotics, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that, in the opinion of the investigator, could impact participant safety
- Significant cardiovascular disease, such as cardiac disease New York Heart Association Class II or greater, myocardial infarction, or cerebrovascular accident within 3 months prior to enrollment, unstable arrhythmias, or unstable angina
- Participants with known coronary artery disease, congestive heart failure not meeting the above criterion or with a left ventricular ejection fraction 50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate
- Major surgical procedure other than for diagnosis within 28 days prior to enrollment or anticipation of need for a major surgical procedure during the study
- Prior allogeneic bone marrow transplantation or solid organ transplant
- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the participant at high risk for treatment complications Illnesses or conditions that interfere with the participant's capacity to understand, follow, and/or comply with study procedures.

Trattamento sperimentale: 

Giredestrant

Trattamento di controllo: 

NA

Centri partecipanti

Nord Italia

IRCCS - IRST Meldola Dino Amadori
Via P. Maroncelli 40 - 47014 Meldola - FC

 

Centro Italia

Fondazione Policlinico A. Gemelli
Largo Agostino Gemelli 8 - 00168 Roma - RM
NB: Arruolamento pazienti non ancora attivo

Riferimento: Prof.ssa Domenica Lorusso
Telefono: 0630158545
Email: domenica.lorusso@policlinicogemelli.it

 

Sud Italia e isole

Istituto Nazionale Tumori IRCCS Fondazione Pascale
Via Mariano Semmola - 80131 Napoli - NA
UO Oncologia Medica Uro-ginecologica

Riferimento: Dr.ssa Carmela Pisano
Telefono: 08117770707
Email: c.pisano@istitutotumori.na.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2022-002443-21

Data di inserimento: 05.07.2023

Promotore

Hoffmann-La Roche

Principal Investigator ITALIA

Istituto Nazionale Tumori IRCCS - Fondazione Pascale, Napoli

Riferimento: Dr.ssa Carmela Pisano

Telefono: 08117770707

Email: c.pisano@istitutotumori.na.it

Localita: Napoli

 

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