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Study on the Effectiveness of Niraparib Rechallenge After Surgery in Ovarian Cancer Patients with Limited Metastasis

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What is this study about?

This clinical trial is focused on studying ovarian cancer, specifically in patients who have a type of cancer progression called oligometastatic progression. This means the cancer has spread to a limited number of other areas. The treatment being tested is a medication called niraparib, which is taken in tablet form. The purpose of the study is to see how effective niraparib is when used again after surgery in patients who have no visible cancer left after their operation.

Participants in the study will take niraparib by mouth. The study will monitor how long patients can go without the cancer getting worse after starting the treatment. This is known as progression-free survival. The study will also look at other factors, such as how long patients live overall and any side effects they might experience. Patients will be followed up regularly to check on their health and the status of their cancer.

The study is designed to help understand if using niraparib again after surgery can help keep the cancer from coming back or spreading further. This research is important for finding better ways to manage ovarian cancer and improve outcomes for patients with this condition.

1 initiation of treatment

The treatment begins 3 to 6 weeks after surgery, once recovery is complete.

The medication used is niraparib tosilate monohydrate, administered in the form of a tablet taken orally.

2 treatment administration

The patient takes the niraparib tablet daily. The dosage and specific instructions are provided by the healthcare provider.

Regular monitoring is conducted to assess the patient’s response to the treatment and to manage any side effects.

3 monitoring and follow-up

Blood samples and tumor tissue samples are collected at the start, every 3 cycles (12 weeks), and at the end of treatment.

The patient’s health and treatment progress are evaluated using imaging tests such as CT or PET-CT scans.

4 end of treatment

The treatment continues until disease progression or unacceptable side effects occur.

The primary goal is to assess the time from treatment initiation until disease progression or death, known as progression-free survival (PFS).

Who Can Join the Study?

  • Must provide a signed document agreeing to participate in the study.
  • Must have previously received a type of treatment called PARPi alone or with another drug called bevacizumab.
  • Must have benefited from the previous PARPi treatment for at least 12 months, or 18 months if there is a BRCA1/2 mutation. This means the treatment helped control the cancer for that time.
  • If the previous treatment was with a drug called niraparib, there should have been no serious side effects or need to stop the treatment.
  • Must be willing to provide samples of tumor tissue and blood at different times during the study.
  • Must be able to take medications by mouth.
  • Must start the study treatment 3 to 6 weeks after surgery, once fully recovered.
  • Women who can have children must agree to use birth control and not donate eggs during the study. They must also have a negative pregnancy test before starting the study treatment.
  • Must have healthy bone marrow, liver, and kidneys, as shown by specific blood test results.
  • Must be available for follow-up appointments during the study.
  • Must be a female aged 18 years or older.
  • Must have a good general health status, as measured by a scale called ECOG with a score of 0 or 1.
  • Must have a life expectancy of at least 16 weeks.
  • Must have a specific type of ovarian cancer called high-grade serous or endometrioid OC with a limited number of cancer spots, known as oligometastatic progression.
  • Must have had surgery to remove cancer with no visible tumor left after the surgery.
  • Must have a normal or slightly elevated level of a marker called CA 125 in the blood.
  • Must have documented information about BRCA1/2 gene status and another status called homologous recombination (HR).

Who Cannot Join the Study?

  • Patients who do not have ovarian cancer with oligometastatic progression. This means the cancer has spread to a few other places in the body.
  • Patients who have not had secondary cytoreductive surgery with no remaining disease. This is a surgery to remove as much of the cancer as possible.
  • Patients who are not female, as the study is only for women.
  • Patients who are considered part of a vulnerable population. This means groups of people 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
Hospital Universitario Y Politecnico La Fe Valencia Spain

Other Sites

Site Name City Country Status
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Universitario De Jaen Jaen Spain
Hospital Universitario De Cruces Barakaldo Spain
Salut Sant Joan De Reus Reus Spain
Hospital Universitario Virgen De La Victoria Malaga Spain
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Hvguldwh Vlju dkqjoapi Barcelona Spain
Hhqhzboz Uwpbtcvrejxzg dm A Czudjr A Coruna Galicia Spain

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

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
01.08.2024

Trial locations

Investigated drugs:

Niraparib is a medication used in this clinical trial to treat ovarian cancer patients. It is being tested to see if it can help prevent the cancer from coming back after surgery. The trial is specifically looking at patients who have a small number of cancerous areas that have spread, known as oligometastatic progression, and who have no remaining visible cancer after a second surgery to remove tumors.

Investigated diseases:

Ovarian Cancer – Ovarian cancer is a type of cancer that begins in the ovaries, which are the female reproductive glands. It often goes undetected until it has spread within the pelvis and abdomen. In its early stages, it may not cause noticeable symptoms, but as it progresses, symptoms can include abdominal bloating, pelvic pain, and changes in bowel habits. Oligometastatic progression refers to a state where the cancer has spread to a limited number of other locations. This progression can affect treatment options and strategies. The disease can vary in its rate of progression, with some cases advancing more rapidly than others.

Trial ID:
2023-508258-24-00
Protocol code:
MEDOPP557
NCT ID:
NCT06180356
Trial Phase:
Therapeutic exploratory (Phase II)

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