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Study Comparing Niraparib and Platinum-Taxane Drug Combination for Patients with Advanced Ovarian Cancer

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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 treatments for ovarian cancer, specifically in patients with a subtype known as homologous recombination-deficient (HRd) Stage III/IV ovarian cancer. The study will compare the effectiveness of a medication called niraparib with a combination of chemotherapy drugs known as platinum-taxane doublet chemotherapy. The chemotherapy involves two drugs, carboplatin and paclitaxel, which are commonly used to treat ovarian cancer. Niraparib is taken orally in the form of capsules, while the chemotherapy drugs are given through an infusion into a vein.

The purpose of the study is to evaluate how well these treatments work in patients who have already received one cycle of chemotherapy with carboplatin and paclitaxel. Participants will be randomly assigned to receive either niraparib or the platinum-taxane chemotherapy. The study will monitor the safety and effectiveness of these treatments over a period of time. Participants will be asked to complete questionnaires about their health and quality of life during the study.

This trial is part of a larger research effort called the OPAL Master Protocol, which aims to explore new treatments and combinations for ovarian cancer. The study will help determine if niraparib can be an effective alternative to traditional chemotherapy for patients with HRd ovarian cancer. The results will contribute to understanding the best treatment options for this type of cancer.

The research process

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

Step 1
Initial treatment phase
Receive an initial cycle of treatment with carboplatin and paclitaxel. These medications are administered as a solution for infusion, which means they are given through a vein.
The goal of this phase is to assess the response to the treatment. Completion of this phase requires receiving at least 50% of the prescribed dose within 5 weeks.
Step 2
Randomization and treatment assignment
After the initial treatment phase, participants are randomly assigned to one of two treatment groups.
One group receives niraparib, which is taken orally in the form of 100 mg hard capsules.
The other group continues with a combination of platinum-taxane doublet chemotherapy, which includes carboplatin and paclitaxel.
Step 3
Treatment administration
Participants in the niraparib group take the medication orally as prescribed by the study protocol.
Participants in the chemotherapy group receive carboplatin and paclitaxel through intravenous infusion according to the study schedule.
Step 4
Monitoring and evaluation
Throughout the study, regular monitoring is conducted to evaluate the response to the treatment.
This includes assessments based on the Response Evaluation Criteria in Solid Tumors (RECIST) to determine the effectiveness of the treatment.
Step 5
Completion of study participation
Upon completion of the treatment phase, participants undergo final evaluations to assess the overall response and any changes in health status.
The study aims to gather data on the safety and efficacy of the treatments for future reference.

Who can join the trial?

8 criteria

The participant must be a female who is 18 years of age or older, able to understand the study procedures, and willing to participate by signing a written consent form.
The participant must have a disease that can be measured according to specific guidelines called RECIST v1.1.
The participant must have been newly diagnosed with Stage III or IV ovarian, fallopian tube, or primary peritoneal cancer, which are types of cancer affecting the female reproductive system.
The participant must provide enough tumor tissue for testing before the study begins and agree to undergo a specific test to check for a condition called **homologous recombination deficiency (HRd)**, which is related to how cells repair DNA. If the participant has certain genetic mutations related to breast cancer, they may join the study before the test results are available, but they still need to provide a tumor sample for confirmation.
The participant must have completed one cycle of treatment with specific chemotherapy drugs called carboplatin and paclitaxel, and not have experienced worsening of the disease after this treatment. Completion means receiving at least 50% of the prescribed dose within 5 weeks.
The participant must not have any known allergies or reactions to the chemotherapy drugs carboplatin and paclitaxel, or to the study drug niraparib, and must not have any pre-existing conditions that would prevent treatment with these drugs.
The participant must not have symptoms of fluid buildup in the abdomen or around the lungs that require removal within one week before signing the consent form.
The participant must agree to complete questionnaires about their health and work productivity throughout the study.

Who cannot join the trial?

5 criteria

Patients who are not female cannot participate.
Patients who do not have confirmed **Stage III to IV ovarian cancer** cannot participate. **Stage III to IV** refers to advanced stages of cancer where it has spread beyond the ovaries.
Patients who do not have **homologous recombination-deficient (HRd)** ovarian cancer cannot participate. **HRd** means the cancer cells have trouble repairing DNA, which is important for the study.
Patients who are not within the specified age range cannot participate. The age range is typically defined by the study but is not specified here.
Patients who belong to a vulnerable population, such as those unable to give consent, cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Hospital Universitario De Navarra
Verified
Pamplona, Spain
Hospital Universitario Hm Sanchinarro
Responsive
Madrid, Spain
Hospital Universitario Quironsalud Madrid
Verified
Pozuelo De Alarcon, Spain

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Investigated drugs

Niraparib
is a medication being studied for its effectiveness in treating ovarian cancer. It is being tested as a neoadjuvant treatment, which means it is given before the main treatment to help shrink the tumor. In this trial, niraparib is being compared to another treatment option to see how well it works in patients with a specific type of ovarian cancer.
Carboplatin
is a chemotherapy drug used to treat various types of cancer, including ovarian cancer. It works by damaging the DNA of cancer cells, which prevents them from growing and dividing. In this trial, carboplatin is used as part of an induction cycle to help evaluate the response of the cancer to treatment.
Paclitaxel
is another chemotherapy medication used in the treatment of ovarian cancer. It works by stopping cancer cells from dividing, which leads to their death. In this study, paclitaxel is combined with carboplatin as part of the initial treatment to assess the cancer's response.
Platinum-Taxane Doublet Chemotherapy
refers to a combination of two chemotherapy drugs, typically a platinum-based drug like carboplatin and a taxane drug like paclitaxel. This combination is commonly used to treat ovarian cancer and is being compared to niraparib in this trial to determine which treatment is more effective as a neoadjuvant therapy.

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 in treating ovarian cancer, particularly in patients with homologous recombination-deficient Stage III to IV ovarian cancer. The main therapeutic indication for niraparib is as a neoadjuvant treatment for ovarian cancer. At the molecular level, niraparib works by inhibiting the enzyme poly (ADP-ribose) polymerase (PARP), which helps repair damaged DNA 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

Ovarian Neoplasms – Ovarian neoplasms refer to abnormal growths that develop in or on the ovaries. These growths can be benign (non-cancerous) or malignant (cancerous). Malignant ovarian neoplasms, commonly known as ovarian cancer, often originate from the surface epithelium of the ovary. The disease typically progresses silently, with symptoms appearing only in advanced stages, which may include abdominal bloating, pelvic pain, and changes in bowel habits. As the cancer advances, it can spread to other parts of the body, such as the abdomen and pelvis. Early detection is challenging, making regular monitoring important for those at risk.