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Study on Niraparib, Carboplatin, and Paclitaxel for Advanced Ovarian Cancer Patients After Tumor Removal

Fast replyRegistered drugNo 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 the treatment of advanced high-grade ovarian cancer, including related conditions such as fallopian tube cancer, primary peritoneal cancer, and clear cell carcinoma of the ovary. The study involves patients who have no remaining tumor mass after initial surgery. The treatment being tested is a medication called niraparib tosylate monohydrate, which is taken as a tablet. This medication is being compared to standard chemotherapy treatments, which include carboplatin and paclitaxel, both given as infusions through a vein.

The purpose of the study is to determine if taking niraparib after three cycles of chemotherapy is as effective as taking it after six cycles. The study will involve patients receiving either three or six cycles of chemotherapy, followed by maintenance treatment with niraparib. Some patients may receive a placebo instead of niraparib to compare the outcomes. The study aims to see if the shorter treatment duration can provide similar benefits in preventing cancer from returning.

Participants in the study will be monitored over time to assess their health and any side effects from the treatments. The study will also look at how long patients live without the cancer coming back and their overall survival rates. The trial will help determine the best approach to using niraparib in treating these types of cancer, potentially offering a more efficient treatment option for patients in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be informed about the trial and will provide written consent to participate.

    The patient must meet specific criteria, such as being postmenopausal or having a non-childbearing status, and must be able to take oral medications.

  2. Step 2

    Initial chemotherapy cycles

    The patient will undergo three cycles of chemotherapy, which includes the administration of carboplatin and paclitaxel through intravenous routes.

    Each cycle will be followed by a medical evaluation to monitor the patient's response to the treatment.

  3. Step 3

    Maintenance therapy with niraparib

    After completing the initial chemotherapy cycles, the patient will begin maintenance therapy with niraparib tosilate monohydrate, taken orally in tablet form.

    The dosage and frequency of niraparib will be determined by the medical team based on the patient's condition and response to previous treatments.

  4. Step 4

    Additional chemotherapy cycles (if applicable)

    If required, the patient may undergo an additional three cycles of chemotherapy with carboplatin and paclitaxel administered intravenously.

    The decision for additional cycles will be based on the patient's medical evaluation and the study's protocol.

  5. Step 5

    Ongoing monitoring and assessments

    Throughout the trial, the patient will have regular assessments to monitor recurrence-free survival and overall health.

    These assessments will include laboratory evaluations, vital signs, and physical examinations to ensure the patient's safety and well-being.

  6. Step 6

    Completion of the trial

    The trial is expected to continue until March 31, 2032, with ongoing monitoring and data collection.

    Upon completion, the patient's overall survival and response to the treatment will be evaluated to determine the effectiveness of the therapy.

Who can join the trial?

15 criteria

  • You must provide written informed consent before any study-related procedures are done.
  • You must be a woman who is either postmenopausal or not able to have children. If you can have children, you need to have a negative pregnancy test before starting the study treatment.
  • You must be 18 years of age or older.
  • You must have advanced high-grade ovarian cancer, which is a specific type of cancer, but not the mucinous type.
  • You must have had surgery to remove the primary tumor, and a CT scan must confirm that no visible tumor remains.
  • You must have tumor samples available for special testing to confirm a specific genetic status called **HRD positive**.
  • Your general health must be good, as measured by a performance status of 0 or 1 on a specific scale called the **ECOG performance status**.
  • You must be able to take medications by mouth.
  • If you have other cancers, they are allowed as long as they do not affect the outlook of your ovarian cancer. The study team must be informed before you join the trial.
  • Your organs and bone marrow must be functioning normally, which includes:
    • Hemoglobin levels of at least 10.0 g/dL without needing a blood transfusion recently.
    • A certain type of white blood cell count, called **absolute neutrophil count**, must be at least 1.5 x 109/L.
    • Platelet count must be at least 100 x 109/L.
    • Total bilirubin, a liver function measure, must be within normal limits, except in certain conditions like **Gilbert’s syndrome**.
    • Liver enzymes, called **ASAT/SGOT** and **ALAT/SGPT**, must be within 2.5 times the normal limit.
    • Serum creatinine, a kidney function measure, must be within normal limits, and creatinine clearance must be over 30 mL/min.

Who cannot join the trial?

6 criteria

  • Patients with any other type of cancer that is not specified in the study.
  • Patients who have not undergone surgery to remove the primary tumor.
  • Patients with remaining tumor mass after surgery.
  • Patients who have not been diagnosed with the specific types of cancer mentioned in the study.
  • Patients who are male, as the study is only for female patients.
  • Patients who are considered part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Niraparib is a medication used in this clinical trial as a maintenance therapy for patients with advanced high-grade ovarian cancer. It is given to patients after they have completed their initial chemotherapy treatment. The goal of using niraparib is to help prevent the cancer from coming back and to extend the time patients remain free from cancer recurrence.

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 for its effectiveness as a maintenance therapy in patients with advanced high-grade ovarian cancer, fallopian tube cancer, and primary peritoneal cancer, particularly those with HRD-positive tumors. The medication works by inhibiting the enzyme poly (ADP-ribose) polymerase (PARP), which is involved in DNA repair. By blocking this enzyme, niraparib helps prevent cancer cells from repairing their DNA, leading to cell death. It is classified as a PARP inhibitor and is being evaluated for its potential to improve recurrence-free survival in patients who have undergone primary tumor debulking.

Investigated diseases

  • High-Grade Ovarian Cancer

    This is a type of cancer that originates in the ovaries and is characterized by rapidly growing, abnormal cells. It is often diagnosed at an advanced stage, such as stage III or IV, according to the FIGO classification. The disease can spread to nearby tissues and organs, including the fallopian tubes and peritoneum. High-grade ovarian cancer is often associated with genetic mutations, such as HRD positivity, which can influence its behavior and progression. The cancer may initially respond to treatment, but there is a risk of recurrence.

  • Fallopian Tube Cancer

    This rare cancer begins in the fallopian tubes, which connect the ovaries to the uterus. It shares similarities with ovarian cancer in terms of symptoms and progression. The disease can spread to nearby organs and tissues, including the ovaries and peritoneum. It is often detected at an advanced stage, making it challenging to manage. The cancer may initially respond to treatment, but recurrence is possible.

  • Primary Peritoneal Cancer

    This cancer originates in the peritoneum, the lining of the abdominal cavity, and is similar to ovarian cancer in its behavior and progression. It can spread to nearby organs and tissues, including the ovaries and fallopian tubes. The disease is often diagnosed at an advanced stage, which can complicate management. Primary peritoneal cancer may initially respond to treatment, but there is a risk of recurrence.

  • Clear Cell Carcinoma of the Ovary

    This is a subtype of ovarian cancer characterized by the presence of clear cells when viewed under a microscope. It is known for its distinct cellular appearance and can behave differently from other types of ovarian cancer. The disease can spread to nearby tissues and organs, including the fallopian tubes and peritoneum. Clear cell carcinoma is often diagnosed at an advanced stage, which can affect its management. The cancer may initially respond to treatment, but recurrence is possible.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-502559-69-01Protocol codeNOGGO-ov53Estimated enrolment640 patientsSponsorNord Ostdeutsche Gesellschaft Fuer Gynaekologische Onkologie e.V.

sourced from the EU Clinical Trials Register and site verification

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