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Study of Olaparib for Patients with Recurrent Ovarian Cancer Without BRCA Gene Mutations

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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 recurrent ovarian cancer in patients who do not have certain genetic mutations in the BRCA1 and BRCA2 genes. The treatment being tested is a medication called Olaparib, which is also known by its code name AZD-2281. Olaparib is taken in the form of film-coated tablets and is used as a maintenance treatment after patients have responded to a type of chemotherapy that includes a drug called platinum.

The purpose of the study is to explore how well Olaparib works in patients with this specific type of ovarian cancer. Participants in the study will take Olaparib tablets by mouth. The study will monitor how long patients remain free from cancer progression, as well as their overall survival and response to the treatment. The study will also look at any side effects experienced by the participants.

This trial is expected to continue until 2027. It aims to provide valuable information about the effectiveness of Olaparib in treating recurrent ovarian cancer in patients without BRCA1 and BRCA2 mutations. The findings could help improve treatment options for this group of patients in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment

    Eligibility is confirmed based on specific criteria, including age, diagnosis of recurrent high-grade ovarian cancer, and absence of certain genetic mutations.

    A signed informed consent is required to confirm awareness and willingness to comply with study requirements.

    Availability of tumor and blood samples for analysis is necessary.

  2. Step 2

    Pre-treatment assessment

    A series of tests are conducted to ensure normal organ and bone marrow function.

    A negative pregnancy test is required for women of childbearing potential.

    Patients must have completed at least four cycles of platinum-based chemotherapy and be enrolled within eight weeks of their last dose.

  3. Step 3

    Treatment initiation

    The treatment involves taking olaparib in the form of film-coated tablets.

    The medication is administered orally, with available dosages of 100 mg and 150 mg tablets.

    The specific dosage and frequency are determined by the study protocol.

  4. Step 4

    Maintenance phase

    Olaparib is used as maintenance therapy after a response to platinum-based chemotherapy.

    The treatment continues as long as it is beneficial and tolerated.

  5. Step 5

    Monitoring and follow-up

    Regular monitoring is conducted to assess the response to treatment and any side effects.

    Progression-free survival is a primary endpoint, with overall survival and response rate as secondary endpoints.

  6. Step 6

    Completion

    The trial is estimated to end by June 30, 2027.

    Final assessments are conducted to evaluate the outcomes of the treatment.

Who can join the trial?

20 criteria

  • Patients must be at least 18 years old.
  • Only female patients with a confirmed diagnosis of relapsed high-grade ovarian cancer, including cancer of the lining of the abdomen (primary peritoneal) or the fallopian tubes, can participate.
  • Patients must not have harmful changes (mutations) in the BRCA1 or BRCA2 genes, which are linked to some types of cancer.
  • Patients should have an ECOG Performance Status of 0 to 2, which is a scale used to assess how a patient's disease is progressing and how the disease affects their daily living abilities.
  • Patients must have a life expectancy of at least 16 weeks.
  • Patients need to sign a consent form to show they understand the study and agree to participate.
  • Patients must provide tumor and blood samples for analysis. The tumor sample should be from the first surgery before any treatment.
  • Patients should have received at least two previous treatments with platinum-based chemotherapy, such as carboplatin or cisplatin.
  • Patients must be considered platinum sensitive, meaning their cancer did not progress for more than 6 months after the last platinum chemotherapy.
  • Patients should show a response to the last chemotherapy, either partial or complete, or have no evidence of disease if surgery was done before chemotherapy.
  • Patients must have received at least four cycles of platinum-based chemotherapy.
  • Patients must join the study within 8 weeks after their last chemotherapy dose.
  • Maintenance treatment, including a drug called bevacizumab, is allowed after the second-to-last platinum treatment.
  • Women who can have children must show they are not pregnant with a negative pregnancy test before starting the study treatment.
  • Patients must have normal organ and bone marrow function, which includes:
    • Hemoglobin levels of at least 10.0 g/dL without a blood transfusion in the past 28 days.
    • An absolute neutrophil count (ANC) of at least 1.5 x 109/L, which measures a type of white blood cell.
    • A platelet count of at least 100 x 109/L, which measures cells that help with blood clotting.
    • Total bilirubin levels of 1.5 times or less than the normal upper limit, which checks liver function.
    • AST and ALT levels of 2.5 times or less than the normal upper limit, unless there are liver metastases, in which case they must be 5 times or less than the normal upper limit. These are enzymes that help check liver health.
    • A creatinine clearance of at least 51 mL/min, which measures kidney function, calculated using the Cockcroft-Gault equation.

Who cannot join the trial?

4 criteria

  • Patients who do not have **recurrent ovarian cancer** that is **wild type** for **germline and somatic BRCA 1 and 2 genes**. This means the cancer does not have certain genetic changes in the BRCA 1 and 2 genes.
  • 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. The age range is not specified here, but it is important for eligibility.
  • Patients who are part of a vulnerable population that the study does not include. This could mean groups like children, pregnant women, or others who need special protection.
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Investigated drugs

Olaparib is a medication used in this clinical trial for patients with recurrent ovarian cancer. It is specifically for those who do not have mutations in the BRCA1 and BRCA2 genes. Olaparib is used as a maintenance treatment after the cancer has responded to platinum-based chemotherapy. Its role is to help keep the cancer from coming back by targeting cancer cells and preventing them from repairing themselves.

What is already known about the treatment

Olaparib – Olaparib is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating recurrent ovarian cancer in patients who do not have BRCA 1 and 2 gene mutations. The main therapeutic indication for Olaparib is as a maintenance treatment for ovarian cancer after a positive response to platinum-based chemotherapy. At the molecular level, Olaparib works by inhibiting the enzyme poly (ADP-ribose) polymerase (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 as a PARP inhibitor in pharmacology.

Investigated diseases

Recurrent Ovarian Cancer Wild Type for Germline and Somatic BRCA 1 and 2 Genes – This form of ovarian cancer occurs when the disease returns after initial treatment and does not have mutations in the BRCA1 or BRCA2 genes. It is characterized by the growth of cancerous cells in the ovaries, which can spread to other parts of the body. The cancer is considered high-grade, meaning the cells look very different from normal cells and tend to grow and spread more quickly. This type of ovarian cancer is often sensitive to platinum-based chemotherapy, which can initially shrink the tumors. However, the cancer may recur, requiring further treatment to manage its progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516841-38-00Estimated enrolment100 patientsSponsorIRCCS Istituto Nazionale Tumori Fondazione Pascale

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