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Study on Niraparib for Maintenance Treatment in Patients with Advanced Ovarian Cancer After Initial Chemotherapy Response

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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 effects of a medication called niraparib in patients with advanced ovarian cancer. Ovarian cancer is a type of cancer that begins in the ovaries, which are part of the female reproductive system. The study is specifically looking at patients who have a type of ovarian cancer known as homologous recombination deficiency, which means their cancer cells have trouble repairing DNA damage. The treatment being tested is niraparib tosylate monohydrate, which is taken as a capsule by mouth. This medication is being compared to a placebo, which looks like the medication but does not contain the active ingredient.

The purpose of the study is to evaluate how effective niraparib is in maintaining the response to initial chemotherapy treatment in patients with advanced ovarian cancer. Patients who have responded well to their first round of chemotherapy, which is a common cancer treatment using drugs to kill cancer cells, will be given either niraparib or a placebo. The study will monitor how long patients remain free from cancer progression, which means the cancer does not get worse, after starting the study treatment.

Participants in the study will take the study medication for up to 36 months, or until their cancer progresses or they experience unacceptable side effects. Throughout the study, patients will have regular check-ups to monitor their health and the status of their cancer. The study aims to provide valuable information on whether niraparib can help keep ovarian cancer from returning or worsening after initial treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization

    After meeting the eligibility criteria, the patient is randomly assigned to one of two groups: one receiving niraparib and the other receiving a placebo. This process is double-blind, meaning neither the patient nor the researchers know which group the patient is in.

  2. Step 2

    Treatment initiation

    The patient begins taking the assigned medication. If assigned to the niraparib group, the patient takes niraparib tosilate monohydrate orally. The dosage is determined by the study protocol and is taken daily.

    If assigned to the placebo group, the patient takes a placebo capsule that looks identical to the niraparib capsule, also taken daily.

  3. Step 3

    Treatment duration

    The treatment continues as long as the patient does not experience disease progression or unacceptable side effects. The duration is determined by the study protocol and the patient's response to the treatment.

  4. Step 4

    Progress monitoring

    Throughout the study, the patient's health and response to the treatment are regularly monitored. This includes assessments of disease progression and any side effects experienced.

    The primary measure of success is progression-free survival (PFS), which is the time from randomization to disease progression or death.

  5. Step 5

    Completion of treatment

    Once the treatment phase is completed, the patient may continue to be monitored for additional outcomes, such as overall survival and quality of life measures.

    Follow-up assessments are conducted at specified intervals, such as 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the end of treatment.

Who can join the trial?

21 criteria

  • Patients must be female and at least 18 years old.
  • Patients must be able to understand the study procedures and agree to participate by signing a written consent form.
  • Patients who can have children must have a negative pregnancy test within 7 days before starting the study treatment.
  • Patients must be postmenopausal (no periods for over a year), surgically unable to have children, or willing to use effective birth control or avoid pregnancy-related activities during the study and for 180 days after the last dose of treatment.
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
  • Patients must be able to take medications by mouth.
  • Patients must have adequate organ function, which includes specific blood and kidney function levels:
  • White blood cells (neutrophils) count of at least 1,500 per microliter.
  • Platelet count of at least 100,000 per microliter.
  • Hemoglobin level of at least 10 grams per deciliter.
  • Kidney function (serum creatinine) within 1.5 times the normal limit or a creatinine clearance of at least 60 mL/min.
  • Total bilirubin within 1.5 times the normal limit.
  • Liver enzymes (AST and ALT) within 2.5 times the normal limit, or 5 times if there are liver metastases.
  • All patients must agree to complete Patient-Reported Outcomes (PROs) during the study and at specific times after the end of treatment.
  • Patients must have available tumor samples from the primary cancer or agree to a new biopsy before starting the study treatment.
  • Patients must have a specific type of ovarian, fallopian tube, or primary peritoneal cancer that is Stage III or IV according to the FIGO criteria.
  • Patients with inoperable Stage III and IV disease, operable Stage IV disease, or those treated with chemotherapy and surgery are eligible.
  • Patients must have received between 6 and 9 cycles of platinum-based chemotherapy and have a complete or partial response after at least 3 cycles.
  • Patients must have a CA-125 level in the normal range or a significant decrease during therapy that remains stable.
  • Patients must be randomized within 12 weeks of the last chemotherapy cycle.
  • All patients must agree to undergo central tumor HRD testing (a test to check for specific genetic changes in the tumor).

Who cannot join the trial?

5 criteria

  • Patients who do not have **advanced ovarian cancer** with **homologous recombination deficiency**. This means the cancer has specific genetic characteristics.
  • Patients who have not had a **complete response** or **partial response** to initial treatment with **platinum-based chemotherapy**. A complete response means no signs of cancer, and a partial response means the cancer has shrunk but is still present.
  • Patients who are not female, as the study is only for female participants.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a vulnerable population that the study does not include.
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Investigated drugs

Niraparib is a medication used in this clinical trial as a maintenance treatment for patients with advanced ovarian cancer. It is given to patients who have already responded well to initial chemotherapy with platinum-based drugs. The goal of using niraparib is to help keep the cancer from coming back or getting worse, which is known as prolonging progression-free survival.

What is already known about the treatment

Niraparib – Niraparib is an oral medication administered in the form of capsules. It is currently being studied in clinical trials as a maintenance treatment for patients with advanced ovarian cancer, particularly those with homologous recombination deficiency, following a positive response to initial platinum-based chemotherapy. The drug works by inhibiting the enzyme poly (ADP-ribose) polymerase (PARP), which plays a role 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 ability to prolong progression-free survival in affected patients.

Investigated diseases

Homologous recombination deficiency advanced ovarian cancer – This is a type of ovarian cancer characterized by a deficiency in the homologous recombination repair pathway, which is crucial for repairing DNA double-strand breaks. This deficiency can lead to genomic instability and tumor progression. The cancer typically affects the ovaries but can also involve the fallopian tubes and peritoneum. It is often diagnosed at an advanced stage, such as Stage III or IV, where the cancer has spread beyond the ovaries. The progression of this cancer can be influenced by genetic mutations, such as those in the BRCA1 or BRCA2 genes, which are involved in DNA repair. The disease may initially respond to chemotherapy, but there is a risk of recurrence or progression over time.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508010-42-00Protocol codePR-30-5017-CEstimated enrolment1 364 patientsSponsorTesaro Inc.

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