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

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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 trial?

17 criteria

  • 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 trial?

4 criteria

  • 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.
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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.

What is already known about the treatment

Niraparib – Niraparib is administered orally in the form of capsules. It is currently being studied in clinical trials, particularly for its effectiveness in treating ovarian cancer with oligometastatic progression. The main therapeutic indication for niraparib is to improve progression-free survival in patients who have undergone surgery for ovarian cancer. At the molecular level, niraparib works by inhibiting the enzyme poly (ADP-ribose) polymerase (PARP), which helps repair damaged DNA in cancer cells, thereby preventing them from growing and dividing. It is classified as a PARP inhibitor in pharmacology.

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508258-24-00Protocol codeMEDOPP557Estimated enrolment30 patientsSponsorMedica Scientia Innovation Research S.L.

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