Long-term Safety Study of Niraparib for Patients with Advanced Ovarian, Breast, or Prostate Cancer Who Completed a Previous Niraparib Study

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What is this study about?

This clinical trial is focused on studying the long-term effects of a medication called niraparib in patients who have previously participated in a study involving this drug. The diseases being studied include advanced forms of ovarian cancer, breast cancer, and prostate cancer. The purpose of the study is to evaluate the safety and how well patients can tolerate niraparib over an extended period.

Participants in this study will continue to receive niraparib, which is available in different forms such as hard capsules and film-coated tablets. The study will monitor patients who have already been receiving niraparib and are considered by their doctors to benefit from ongoing treatment. The medication is taken orally, meaning it is swallowed in the form of a pill or capsule.

Throughout the study, the health and well-being of participants will be closely observed. This includes checking for any side effects or changes in health status, such as alterations in blood tests or vital signs. The study aims to ensure that niraparib remains a safe and effective treatment option for those with advanced cancer who have previously responded well to it.

1 joining the study

Upon joining the study, the patient must provide written consent, indicating understanding of the study procedures and agreement to participate.

The patient must be willing and able to comply with scheduled visits, treatment plans, and any other study procedures.

2 treatment continuation

The patient will continue receiving treatment with niraparib, which is the active substance in the study.

The medication is administered orally in the form of either Zejula 100 mg hard capsules or Zejula 100 mg film-coated tablets.

3 medication regimen

The patient will take the prescribed dose of niraparib as directed by the study protocol.

The frequency and duration of administration will be determined by the investigator based on the patient’s response and the study requirements.

4 safety and monitoring

The primary objective is to evaluate the long-term safety and tolerability of niraparib.

Safety will be assessed through monitoring of any adverse effects, changes in performance status, laboratory assessments, vital signs, and physical examinations.

5 use of contraception

Patients of childbearing potential who are sexually active, and their partners, must use effective contraception during the study and for 180 days after the last dose.

Male patients must use a condom and refrain from donating sperm during the study and for 90 days after the last dose.

6 study duration

The estimated end date for the study is November 13, 2025.

The study is designed to continue as long as the patient is benefiting from the treatment, as assessed by the investigator.

Who Can Join the Study?

The patient must be able to understand the study procedures and agree to participate by providing written consent.
The patient must be willing and able to attend scheduled visits, follow treatment plans, and participate in other study procedures.
The patient must currently be receiving treatment with niraparib (a type of medication) either alone or with other treatments in a study sponsored by GSK/TESARO that has met its main goals.
The patient must be benefiting from the niraparib treatment as determined by the study doctor according to the study’s requirements.
Patients who can have children and are sexually active, along with their partners, must agree to use an effective form of birth control during the study and for 180 days after the last dose of the study drug.
Male patients must use a condom and must not donate sperm during the study treatment with niraparib and for 90 days after the last dose of the study drug.

Who Cannot Join the Study?

Patients who do not have advanced ovarian, breast, or prostate cancer cannot participate.
Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are not female or male cannot participate, as the study includes both genders.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or people with certain disabilities who may need special protection in research.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medical University Of Graz	Graz	Austria
Medical University Of Vienna	Vienna	Austria
Hospital Clinico San Carlos	Madrid	Spain

Other Sites

Site Name	City	Country
MVZ-Onkologie Velbert GbR	Velbert	Germany
Centre Antoine Lacassagne	Nice	France
Centrul De Oncologie SF Nectarie S.R.L.	Craiova	Romania
Azienda Socio Sanitaria Territoriale Di Cremona	Cremona	Italy
L’Hopital Prive Du Confluent	Nantes	France
Fbmtzegvt Puyi Lp Ixsisnbvixhat Besbcjaor Dkf Hqlvzvpt Uwayydugxtrng La Pfc	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	30.11.2023
France	Not recruiting	30.11.2023
Germany	Not yet recruiting	30.11.2023
Italy	Recruiting	30.11.2023
Romania	Not yet recruiting	30.11.2023
Spain	Recruiting	30.11.2023

Trial locations

Investigated drugs:

Niraparib Tosilate Monohydrate

Niraparib is a medication used in this clinical trial. It is designed to help treat certain types of cancer by interfering with the cancer cells’ ability to repair their DNA. This can lead to the death of the cancer cells and potentially slow down or stop the growth of the cancer. The trial aims to assess the long-term safety and tolerability of continuing treatment with Niraparib for patients who have already participated in a previous study and are believed to benefit from ongoing use of the medication.

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 like abdominal bloating, pelvic pain, and changes in bowel habits may occur. The disease can spread to other parts of the body, making it more challenging to treat. It is most common in women over the age of 50, but it can occur at any age. The progression of ovarian cancer can vary, with some types growing slowly and others more rapidly.

Breast Cancer – Breast cancer is a disease in which cells in the breast grow out of control. It can begin in different parts of the breast, most commonly in the ducts or lobules. As the cancer progresses, it may spread to nearby lymph nodes or other parts of the body. Symptoms can include a lump in the breast, changes in breast shape, dimpling of the skin, or discharge from the nipple. The disease can affect both men and women, although it is much more common in women. The rate of progression can vary depending on the type and stage of the cancer.

Prostate Cancer – Prostate cancer is a form of cancer that occurs in the prostate, a small gland that produces seminal fluid in men. It is one of the most common types of cancer in men and often grows slowly. In its early stages, prostate cancer may not cause any symptoms, but as it advances, it can lead to difficulty urinating, blood in the urine, or pelvic discomfort. The disease can spread to bones and other organs if not managed. The progression can vary, with some types remaining confined to the prostate and others spreading more aggressively. It is most frequently diagnosed in older men.

Trial ID:

2023-506618-29-00

Protocol code:

213409

NCT ID:

NCT04641247

Trial Phase:

Therapeutic exploratory (Phase II)

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Long-term Safety Study of Niraparib for Patients with Advanced Ovarian, Breast, or Prostate Cancer Who Completed a Previous Niraparib Study

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?