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Study of Olaparib for Patients with Advanced BRCA-Mutated Ovarian Cancer After Initial Platinum-Based Chemotherapy

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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 BRCA mutated advanced ovarian cancer, which is a type of cancer that affects the ovaries and is linked to specific genetic changes known as BRCA mutations. The study will use a treatment called olaparib, which is taken as a tablet. Olaparib is designed to help maintain the health of patients who have already received their first round of chemotherapy, a common cancer treatment that uses drugs to kill cancer cells.

The purpose of this study is to compare the effects of olaparib with a placebo in patients with advanced ovarian cancer who have responded well to their initial chemotherapy. Participants will be randomly assigned to receive either olaparib or a placebo. The study will last for a period of up to 36 months, during which time the health of the participants will be closely monitored. This includes regular check-ups and assessments to see how the cancer is responding to the treatment.

Throughout the study, the main focus will be on how long patients remain free from cancer progression, which means the cancer does not get worse. This is known as progression-free survival. The study will also look at other important factors, such as overall survival and any side effects that may occur. The information gathered from this study will help determine the effectiveness of olaparib as a maintenance therapy for patients with BRCA mutated advanced ovarian 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
Joining the study
Upon joining the study, eligibility is confirmed. This includes having a BRCA mutation and having completed first-line platinum-based chemotherapy for advanced ovarian cancer.
The study is designed for patients who have shown a complete or partial response to initial treatment.
Step 2
Randomization
Participants are randomly assigned to receive either olaparib or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.
Step 3
Treatment administration
The treatment involves taking olaparib or a placebo orally. The medication is available in two dosages: 150 mg and 100 mg film-coated tablets.
The specific dosage and frequency of administration are determined by the study protocol and are followed throughout the trial.
Step 4
Monitoring and assessments
Regular assessments are conducted to monitor the progression of the disease. This includes physical examinations, vital signs checks, and laboratory tests.
The primary focus is on progression-free survival, which is evaluated using specific criteria to determine the effectiveness of the treatment.
Step 5
Completion of the study
The study is expected to continue until September 2029. Participants will be monitored for any changes in their condition and for any side effects of the treatment.
Secondary outcomes, such as overall survival and time to progression, are also assessed to provide a comprehensive understanding of the treatment's impact.

Who can join the trial?

8 criteria

Must be a female patient.
Must have newly diagnosed, high-risk advanced ovarian cancer, specifically **BRCA mutated** high-grade serous or high-grade endometrioid ovarian cancer, primary peritoneal cancer, and/or fallopian-tube cancer.
Must have completed first-line **platinum-based chemotherapy**. This means treatment with drugs like carboplatin or cisplatin, given through a vein or directly into the abdomen.
For patients with **Stage III** cancer, there must have been one attempt at surgery to remove as much of the tumor as possible, either before or after starting chemotherapy.
For patients with **Stage IV** cancer, there must have been either a biopsy or surgery to remove as much of the tumor as possible, either before or after starting chemotherapy.
Must have a documented mutation in the **BRCA1** or **BRCA2** genes that is known or suspected to be harmful.
Must have shown a complete or partial response to the first-line platinum-based chemotherapy, meaning the cancer has shrunk or disappeared, and there is no sign of the disease getting worse on a scan or through a blood test called **CA-125**.
Patients with stable disease, meaning the cancer has not changed, are not eligible.

Who cannot join the trial?

5 criteria

Patients who do not have a **BRCA mutation**. A BRCA mutation is a change in a specific gene that can increase the risk of certain cancers.
Patients who do not have **advanced ovarian cancer** at **FIGO Stage III-IV**. FIGO stages are used to describe how much cancer has spread.
Patients who are not in a **clinical complete response** or **partial response** after their first 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 there.
Patients who are not female, as the study is only for female participants.
Patients who are not considered part of a **vulnerable population**. This term refers to groups of people who might need special protection or care.

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Verified sites

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

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain
Institut De Cancerologie De Lorraine
Responsive
Vandoeuvre Les Nancy, France
Istituto Europeo Di Oncologia S.r.l.
Responsive
Milan, Italy

Trial locations

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Investigated drugs

Olaparib is a medication used in this clinical trial as a maintenance therapy for patients with advanced ovarian cancer who have a specific genetic mutation known as BRCA. After these patients have completed their initial treatment with platinum-based chemotherapy and have shown a complete or partial response, olaparib is given to help prevent the cancer from coming back. It works by interfering with the cancer cells' ability to repair their DNA, which can help to slow down or stop the growth of the cancer.

Olaparib

What is already known about the treatment

Olaparib – Olaparib is administered orally in the form of tablets. It is currently recognized in medical literature as a treatment option for certain types of cancer, particularly those with specific genetic mutations. The main therapeutic indication for Olaparib is BRCA mutated advanced ovarian cancer, especially following initial chemotherapy. At the molecular level, Olaparib works by inhibiting an enzyme called PARP, which helps repair DNA damage in cells. By blocking this enzyme, Olaparib prevents cancer cells from repairing themselves, leading to their death. It is classified pharmacologically as a PARP inhibitor.

Investigated diseases

BRCA Mutated Advanced Ovarian Cancer – This is a type of ovarian cancer characterized by mutations in the BRCA1 or BRCA2 genes, which are involved in DNA repair. It typically occurs at an advanced stage, specifically FIGO Stage III or IV, indicating that the cancer has spread beyond the ovaries to other parts of the abdomen or beyond. The disease often presents with symptoms such as abdominal bloating, pelvic pain, and changes in bowel habits. As the cancer progresses, it may lead to the accumulation of fluid in the abdomen and difficulty eating. The progression of the disease is monitored using criteria like the Response Evaluation Criteria in Solid Tumours (RECIST). This type of cancer is often treated with chemotherapy, and its progression is assessed by measuring the time until the disease worsens or spreads further.