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Study on Niraparib's Effects and Safety in Patients with High-Grade Serous Ovarian Cancer

Verified siteRegistered 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 effects of the medication niraparib in patients with certain types of ovarian cancer. Specifically, it involves women with high-grade serous epithelial ovarian, tubal, or primary peritoneal cancers. The treatment being tested is Zejula, which contains the active ingredient niraparib tosilate monohydrate. This medication is taken as a hard capsule and is used as a maintenance treatment to help prevent the cancer from returning after initial chemotherapy.

The purpose of the study is to explore how the body processes niraparib and how this might relate to side effects, particularly those affecting the blood and kidneys. The study will look at different factors that might influence these side effects, such as individual patient characteristics and how the drug is absorbed and used by the body. Participants will receive either a standard dose of 300 mg per day or a reduced dose of 200 mg per day, depending on the doctor's decision.

Throughout the study, researchers will monitor the participants' health and any side effects they experience. They will also assess the quality of life of the participants and how it relates to any side effects observed. The study aims to identify factors that could predict side effects and to develop models that could help in understanding these effects better. The study is expected to continue until 2029, with recruitment starting in 2024.

The research process

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

Step 1
Joining the study
Participation begins after meeting specific criteria, including being a woman over 18 with high-grade serous epithelial ovarian, tubal, or primary peritoneal cancer.
Eligibility requires having completed 4 to 6 courses of platinum-based chemotherapy and a 6 to 8-week interval before starting the study medication.
Informed consent must be signed, and participants must be affiliated with a social security scheme.
Step 2
Medication administration
The study involves taking Zejula 100 mg hard capsules, which contain the active substance niraparib tosilate monohydrate.
The medication is taken orally, with a standard dose of 300 mg per day or a reduced dose of 200 mg per day, as determined by the investigator.
The treatment serves as maintenance therapy for ovarian cancer, whether or not it is BRCA mutated.
Step 3
Monitoring and assessments
Regular monitoring is conducted to identify any clinical, biological, or pharmacokinetic factors that may lead to hematological or renal toxicities.
Assessments include measuring pharmacokinetic parameters and their relation to progression-free survival (PFS) at 24 months.
Quality of life is evaluated and correlated with any observed toxicities.
Step 4
Completion of the study
The study is estimated to conclude by June 11, 2029.
Participants are required to use effective contraception during the treatment and for up to 6 months after stopping the medication if they are of childbearing age.

Who can join the trial?

10 criteria

Women aged over 18
Must have a confirmed diagnosis of high-grade serous epithelial ovarian, tubal, or primary peritoneal cancer. This means the cancer has been identified and classified by a medical professional.
Should have already received 4 to 6 courses of platinum-based chemotherapy, which is a type of cancer treatment using drugs that contain the metal platinum.
There must be a need for maintenance treatment with the drug niraparib, either at a standard dose of 300 mg/day or a reduced dose of 200 mg/day, as decided by the doctor.
Initial glomerular filtration rate (a test to check how well the kidneys are working) should be at least 30 ml/min/1.73m², according to a specific formula.
Must have normal liver function, with a bilirubin level (a substance made by the liver) less than 1.5 times the normal level.
There should be a gap of 6 to 8 weeks between the last course of platinum-based chemotherapy and the start of treatment with niraparib.
For women who can have children: must use effective contraception during treatment and for up to 6 months after stopping treatment. This can include hormonal methods, an IUD, tubal ligation, abstinence, or partner's vasectomy.
Must have been informed about the study and have given signed informed consent, meaning they agree to participate after understanding the details of the study.
Must be affiliated with a social security scheme or be a beneficiary of such a scheme, which means having access to health insurance or similar support.

Who cannot join the trial?

3 criteria

Patients who do not have high-grade serous epithelial ovarian, tubal, or primary peritoneal cancers cannot participate.
Patients who are not female cannot participate.
Patients who are considered part of a vulnerable population cannot participate. A vulnerable population includes groups who may have limited ability to protect their own interests, such as children or those with certain disabilities.

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Centre Hospitalier Lyon Sud
Pierre Benite, France

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Investigated drugs

Niraparib is a medication used in this clinical trial to study its effects on ovarian cancer. It is specifically being examined for its pharmacokinetic properties, which means how the drug is absorbed, distributed, metabolized, and excreted in the body. The trial aims to understand the relationship between these properties and any blood-related or kidney-related side effects that may occur. Niraparib is used as a maintenance treatment for high-grade serous ovarian cancer, whether or not the cancer has a BRCA mutation.

Niraparib Tosilate Monohydrate

What is already known about the treatment

Niraparib – Niraparib is administered orally in the form of capsules. It is currently being studied for its pharmacokinetic properties and potential hematological toxicity in patients with high-grade serous ovarian, tubal, or primary peritoneal cancers. The medication is used as a maintenance treatment for these cancers, whether they have BRCA mutations or not. Niraparib works by inhibiting the enzyme poly (ADP-ribose) polymerase (PARP), which helps repair DNA damage in cells. By blocking this enzyme, niraparib prevents cancer cells from repairing themselves, leading to their death. It is classified as a PARP inhibitor in pharmacology.

Investigated diseases

High-Grade Serous Ovarian Cancer
This is a type of cancer that originates in the cells on the surface of the ovary. It is characterized by the rapid growth of abnormal cells that can invade nearby tissues and 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 spread to the lining of the abdomen and other organs, making it more challenging to manage. High-grade serous ovarian cancer is known for its aggressive nature and tendency to recur after initial treatment. It is the most common and severe form of ovarian cancer.
Primary Peritoneal Cancer
This cancer develops in the peritoneum, a thin layer of tissue lining the abdomen and covering the uterus, bladder, and rectum. It shares many similarities with epithelial ovarian cancer, including symptoms, progression, and treatment approaches. The disease often presents with nonspecific symptoms such as abdominal pain, bloating, and changes in bowel habits, which can complicate early detection. As it advances, the cancer can spread throughout the abdominal cavity and affect other organs. Primary peritoneal cancer is often diagnosed at an advanced stage due to its subtle initial symptoms. It is considered a rare disease but behaves similarly to ovarian cancer.
Fallopian Tube Cancer
This rare cancer originates in the fallopian tubes, which connect the ovaries to the uterus. It is often detected incidentally during surgery for other conditions, as its symptoms can be vague and nonspecific. Common symptoms include abdominal pain, unusual vaginal discharge, and pelvic pressure. The disease can spread to nearby organs and tissues, including the ovaries and peritoneum, as it progresses. Fallopian tube cancer is similar in behavior and treatment to ovarian cancer, and it is often grouped with ovarian and peritoneal cancers in clinical studies. Early detection is challenging due to the lack of specific symptoms.