Study on the Effects of ZN-c3 for Patients with High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

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What is this study about?

This clinical trial is focused on studying the effectiveness and safety of a medication called azenosertib, also known by its code name ZN-c3. The study is specifically for patients with a type of cancer known as High-Grade Serous Ovarian Cancer, which can also affect the fallopian tubes or the lining of the abdomen, known as the peritoneum. The purpose of the study is to evaluate how well ZN-c3 works in treating this cancer and to understand any side effects it may cause.

Participants in the study will receive ZN-c3 in the form of film-coated tablets taken orally. The study will be conducted in two parts. In the first part, the focus will be on determining the safety and how well patients can tolerate ZN-c3. The second part will investigate the medication’s ability to reduce or eliminate the cancer. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of ZN-c3.

The study will take place over a period of time, with regular check-ups and assessments to monitor the participants’ health and the cancer’s response to the treatment. The goal is to gather information that could lead to better treatment options for patients with this type of cancer. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and well-being.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, type of cancer, and previous treatments.

The study focuses on individuals with high-grade serous ovarian, fallopian tube, or primary peritoneal cancer.

2 initial assessment

An initial assessment is conducted to evaluate the current health status and ensure all eligibility criteria are met.

This includes confirming the presence of measurable lesions and assessing overall health and organ function.

3 treatment phase 1b

The first part of the treatment involves taking azenosertib (also known as ZN-c3) orally.

The main goal is to determine the safety and tolerability of the medication.

4 monitoring and adjustments

Regular monitoring is conducted to observe any side effects or adverse events.

Adjustments to the dosage may be made based on individual tolerance and response.

5 treatment phase 2

In the second phase, the focus shifts to evaluating the antitumor activity of azenosertib.

The objective response rate is assessed to determine the effectiveness of the treatment.

6 ongoing evaluation

Throughout the study, ongoing evaluations are conducted to measure response duration, progression-free survival, and overall survival.

These assessments help in understanding the long-term benefits and risks of the treatment.

7 completion of study

The study is estimated to conclude by September 2027.

Final assessments are made to gather comprehensive data on the treatment’s efficacy and safety.

Who Can Join the Study?

  • Must be at least 18 years old at the time of giving consent to participate.
  • Must have a confirmed diagnosis of recurrent high-grade serous ovarian, fallopian tube, or primary peritoneal cancer. This means the cancer has come back after treatment and is of a specific type.
  • Must have platinum-resistant disease, meaning the cancer does not respond well to platinum-based chemotherapy. You can have had one to four previous treatments, or up to five in some cases.
  • Must have at least one measurable lesion. This means there is a tumor that can be measured to see if it changes in size during the study.
  • Must have a Performance Status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG). This score indicates how well you can carry out daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to do light work.
  • Must have adequate hematologic and organ function. This means your blood and organs are working well enough to participate in the study.

Who Cannot Join the Study?

  • Patients who have a different type of cancer than the specific ones being studied, which are High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer.
  • Patients who are not within the specified age range for the study.
  • Patients who do not meet the gender requirements for the study.
  • Patients who are considered part of a vulnerable population that the study is not designed to include.

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
Centr Georges Francois Leclerc Dijon France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Katholieke Universiteit te Leuven Leuven Belgium
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Centre Antoine Lacassagne Nice France
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
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
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku Bialystok Poland
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Jagiellońskie Centrum Innowacji Sp. z o.o. Cracow Poland
Med Polonia Sp. z o.o. Poznan Poland
Ospedale San Raffaele S.r.l. Milan Italy
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Institut de Cancérologie de l’Ouest Saint-Herblain France
Crjvzckga Upfxoxzfxapupo Szoyxsjwv Woluwe-Saint-Lambert Belgium
Cfrmmb Lafe Bxgpei Lyon France
Sbeigufr Pfzuymbtx Shb z ovlx Gdynia Poland
Ogjmspmoixgldtbfpezjwbhmmh Aalst Belgium
Binlurak Uoyhvyxvku Hzpgopdd Cdtqwx Besançon France
Njsxlofi Ieuinzin Orocpqsog Ikr Mshyl Shehhxplzktejjggmxxjkoytfqdt Ibgdcsxd Bsbtcool Cracow Poland
Aurcavd Ujehl Sgestxztu Lzoivp Dn Bxhknoc Bologna Italy
Fgdtptsmy Pqbx Lw Ixurzahmmvlsi Bqzkzcnol Dnk Hufxpgmk Uasruwziejzqp Lx Pkm Madrid Spain
Hhpjheve Vckq daccrvai Barcelona Spain
Cawwre Olcaq Lvallfi Lille France
Huxzhnsm Uyiimjcvcmzxra Svmvbrnogm &jrcjfk Heifgmy dz Htyhdrszpbk STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
31.01.2024
France France
Not recruiting
31.01.2024
Italy Italy
Recruiting
31.01.2024
Poland Poland
Recruiting
31.01.2024
Spain Spain
Recruiting
31.01.2024

Trial locations

ZN-c3 is an investigational medication being studied for its potential to treat certain types of cancer, specifically high-grade serous ovarian, fallopian tube, or primary peritoneal cancer. The trial aims to evaluate how safe and tolerable this medication is for patients, as well as its effectiveness in reducing or controlling the growth of tumors in these types of cancer.

High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer – This is a type of cancer that originates in the cells lining the ovaries, fallopian tubes, or the peritoneum, which is the tissue lining the abdominal wall and covering abdominal organs. It is characterized by the rapid growth of abnormal cells that can spread to other parts of the body. The disease often presents with vague symptoms such as abdominal bloating, pelvic pain, and changes in bowel habits, which can lead to a delay in diagnosis. As the cancer progresses, it may cause more noticeable symptoms and can spread to nearby organs and tissues. The high-grade serous subtype is known for its aggressive nature and tendency to be diagnosed at an advanced stage.

Trial ID:
2022-502983-19-00
Protocol code:
ZN‑c3-005
NCT ID:
NCT05128825
Trial Phase:
Therapeutic exploratory (Phase II)

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