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Study of Azenosertib (ZN-c3) for Women with Recurrent or Persistent Uterine Serous Carcinoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called uterine serous carcinoma, which is a form of endometrial cancer that can be difficult to treat when it comes back or doesn’t go away. The study is testing a new treatment called azenosertib, also known by its code name ZN-c3. This medication is being evaluated to see how safe it is and how well it works in treating this specific type of cancer.

The trial will involve taking the medication in the form of a film-coated tablet. Participants will be monitored to understand how their bodies respond to the treatment and to check for any side effects. The study aims to gather information on the medication’s ability to reduce or control the cancer and to assess its overall safety for patients.

Throughout the study, participants will receive regular check-ups and tests to track their progress. The goal is to determine if ZN-c3 can be a beneficial treatment option for women with recurrent or persistent uterine serous carcinoma, providing new hope for those who have limited treatment options. The study will also compare the effects of ZN-c3 with other treatments, including a placebo, to ensure comprehensive results.

1 initiation of treatment

Upon joining the study, the treatment begins with the administration of azenosertib, also known as ZN-c3. This medication is taken orally in the form of a hard capsule.

The primary goal at this stage is to assess the safety and tolerability of ZN-c3 in individuals with recurrent or persistent uterine serous carcinoma.

2 monitoring and assessment

Throughout the trial, regular monitoring is conducted to evaluate the frequency and severity of any side effects, known as treatment-emergent adverse events (TEAEs).

Laboratory tests are performed to check for any abnormalities, and adjustments to the dosage may be made if necessary.

3 evaluation of treatment effectiveness

The effectiveness of ZN-c3 is assessed by measuring the overall response rate (ORR) using specific criteria known as RECIST v1.1.

This involves determining the reduction in tumor size or the complete disappearance of the tumor.

4 continuation of treatment

If the treatment is well-tolerated and shows signs of effectiveness, it continues as planned.

The duration of the treatment is determined by the study protocol and the individual’s response to the medication.

5 final assessment and conclusion

At the end of the study, a comprehensive assessment is conducted to evaluate the overall outcomes of the treatment.

The study aims to conclude by May 31, 2025, with all data collected and analyzed to determine the potential benefits and risks of ZN-c3 for future use.

Who Can Join the Study?

  • You must provide signed informed consent before starting any study-related procedures.
  • You must be a female who is 18 years old or older.
  • You must have a confirmed diagnosis of recurrent or persistent uterine serous carcinoma (USC), which means the cancer has come back or continues to exist. There should be no other proven effective treatment options available, or you did not tolerate or refused any available standard treatment. If you have endometrial carcinoma with mixed histology, the serous component must be at least 5% of the tumor. Carcinosarcomas are not eligible.
  • Your ECOG Performance Status (PS) must be 0 or 1, which means you are fully active or have some symptoms but can carry out light work.
  • You must have measurable disease according to RECIST 1.1 criteria, which means the cancer can be measured by scans or physical exams, and it has not been previously treated with radiation or has progressed after radiation therapy.
  • You must have had prior therapy for endometrial cancer, including a platinum-based chemotherapy regimen and a PD-(L)1 inhibitor, unless you are not eligible or it is unavailable in your region. If you have known HER2-positive tumors, you must have had at least one HER2-targeted therapy, unless you are not eligible or it is unavailable in your region.
  • You must provide a FFPE tumor tissue block collected within 3 years before giving informed consent.
  • You must have adequate blood and organ function during the screening period, including:
    • ANC (a type of white blood cell) of at least 1.5 x 109/L
    • Hemoglobin (Hgb) of at least 9.0 g/dL without a blood transfusion in the prior 14 days
    • Platelet count of at least 100 x 109/L
    • ALT and AST (liver enzymes) levels not more than 3 times the upper limit of normal (ULN), or not more than 5 times ULN if due to liver metastases
    • Total serum bilirubin not more than 1.5 times ULN, or not more than 3 times ULN in the case of Gilbert’s Syndrome
    • Creatinine clearance (CrCl) of at least 30 mL/min based on the Cockcroft-Gault method
  • If you are a female of childbearing potential, you must agree to use an effective method of contraception before the first dose and for at least 6 months after the last dose of the study drug.
  • You must be willing and able to attend scheduled visits, follow the treatment plan, and undergo laboratory tests and other study procedures.

Who Cannot Join the Study?

  • Patients who are not female cannot participate.
  • Patients who do not have recurrent or persistent uterine serous carcinoma cannot participate. This is a type of cancer that affects the lining of the uterus and has either come back or continues to exist.
  • Patients who are considered part of a vulnerable population cannot participate. This means individuals who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Centro Ricerche Cliniche Di Verona S.r.l. Verona Italy
Azienda Ospedaliero Universitaria Di Modena Modena Italy
MD Anderson Cancer Center Madrid Spain
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Virgen del Rocío University Hospital Sevilla Spain
Ospedale San Raffaele S.r.l. Milan Italy
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Hopital Prive Des Cotes D’armor Plerin France
Centre Hospitalier Lyon Sud Pierre Benite France
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Iwpoworx Chpudk Dmzpsdpgerhthfvix L'hospitalet De Llobregat Spain
Pdcc Tqkvs Hsweqpaf Utzwpjjcdprz Sabadell Spain
Iaybsdzj Rqomxgbrh Pac Lq Skztob Dlu Tdaesi Dzvr Aonvnxi Iich Sundji Meldola Italy
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Hhhfsqzg Vypz dhjgutmj Barcelona Spain
Cuikei Orzjk Lyrutzs Lille France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
31.05.2024
Italy Italy
Not recruiting
31.05.2024
Spain Spain
Not recruiting
31.05.2024

Trial locations

Investigated drugs:

ZN-c3 is a medication being studied for its potential to treat women with recurrent or persistent uterine serous carcinoma, a type of cancer. The trial aims to assess how safe and tolerable this medication is for patients, as well as its ability to reduce or control the tumor.

Investigated diseases:

Uterine Serous Carcinoma – Uterine serous carcinoma is a type of endometrial cancer that originates in the lining of the uterus. It is known for its aggressive nature and tendency to spread quickly beyond the uterus. This cancer is characterized by the presence of serous cells, which are a type of epithelial cell. It often presents in postmenopausal women and can be associated with genetic mutations. The disease may recur or persist even after initial treatment, making it challenging to manage. Progression involves the potential spread to other parts of the body, including the lymph nodes and abdominal cavity.

Trial ID:
2023-507324-23-00
Protocol code:
ZN‑c3-004
NCT ID:
NCT04814108
Trial Phase:
Therapeutic exploratory (Phase II)

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