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Study on Olaparib for Maintenance Therapy in Patients with Newly Diagnosed Advanced Ovarian, Fallopian Tube, and Peritoneal 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 the effects of a medication called Olaparib, also known by its code name AZD-2281, in treating certain types of cancer. The cancers being studied are advanced forms of ovarian cancer, fallopian tube cancer, and primary peritoneal cancer that do not have specific genetic changes known as BRCA mutations. The purpose of the study is to understand how effective Olaparib is as a maintenance treatment, which means it is used to help keep the cancer from coming back after initial treatment.

Participants in the study will take Olaparib in the form of film-coated tablets, which are taken by mouth. The study will follow a single group of patients who have been newly diagnosed with these types of cancer and have responded well to their first round of chemotherapy. The study will last for a period of up to 24 months, during which the patients will be monitored to see how long they remain free from cancer progression, which is when the cancer does not get worse.

The study will also look at various factors that might help predict how well patients will do with this treatment. These factors include certain characteristics of the patients and their tumors. The goal is to identify which patients might have a better outcome in terms of overall survival and to understand the safety and side effects of the treatment. This information will help doctors make better decisions about using Olaparib for these types of cancer in the future.

The research process

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

  1. Step 1

    Joining the study

    Upon joining the study, the first step involves signing an informed consent form. This document confirms understanding of the study and agreement to participate.

    Eligibility is confirmed based on specific criteria, such as age, medical history, and current health status. This includes a diagnosis of advanced ovarian, fallopian tube, or primitive peritoneal cancer without BRCA mutations.

  2. Step 2

    Initial assessments

    Initial assessments are conducted to establish a baseline for health status. These assessments include blood tests, imaging studies, and other necessary evaluations.

    These tests ensure normal organ and bone marrow function and confirm the absence of pregnancy for women of childbearing potential.

  3. Step 3

    Medication administration

    The study involves taking olaparib, which is provided in the form of film-coated tablets. The medication is taken orally.

    The dosage is either 150 mg or 100 mg, as prescribed by the study team. The frequency and duration of administration are determined by the study protocol.

  4. Step 4

    Regular follow-up visits

    Regular follow-up visits are scheduled to monitor health and response to the medication. These visits include physical examinations, blood tests, and other necessary assessments.

    The frequency of these visits is determined by the study protocol, typically occurring every four weeks.

  5. Step 5

    End of study participation

    Participation in the study concludes after a specified period or if certain health criteria are met. This is determined by the study protocol.

    Final assessments are conducted to evaluate the overall health and any effects of the medication.

Who can join the trial?

15 criteria

  • Must provide a signed informed consent before starting any study-related procedures.
  • Must be a female aged 18 years or older.
  • Must have been diagnosed with advanced high-grade serous or high-grade endometrioid epithelial ovarian cancer, which can include primary peritoneal or fallopian tube cancer.
  • Must have shown a complete or partial response to the first line of platinum-based treatment, but not including Bevacizumab.
  • Must not have mutations in the BRCA 1/2 genes, which are specific genetic markers.
  • Must have a life expectancy of at least 16 weeks.
  • Must have an ECOG Performance Status of 0 to 1, which means being fully active or having some symptoms but nearly fully active.
  • Must have enough tumor tissue available from the primary surgery for further analysis.
  • Must be enrolled in the study within 8 weeks after the last dose of chemotherapy.
  • Must be able to take medications by mouth.
  • If of childbearing potential, must be postmenopausal or have a negative pregnancy test before starting the study treatment.
  • If of childbearing potential, must agree to use effective contraception and ensure their partners use a male condom during the study and for at least 6 months after the last dose of the study drug.
  • Must have normal organ and bone marrow function, which includes specific blood and liver function tests within normal ranges.
  • Must have a creatinine clearance of at least 51 mL/min, which is a measure of kidney function.
  • Must be willing and able to attend scheduled visits, follow the treatment plan, and undergo laboratory tests and other trial procedures.

Who cannot join the trial?

3 criteria

  • Patients who do not have **BRCA wild-type advanced ovarian, fallopian tube, or primitive peritoneal cancer** cannot participate. BRCA wild-type means that the BRCA gene does not have certain mutations.
  • Only **female** patients can participate. Male patients are not eligible.
  • Patients who are considered part of a **vulnerable population** are not eligible. This typically includes groups like pregnant women, children, or those unable to give consent.
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Investigated drugs

Olaparib is a medication used in this clinical trial as a maintenance therapy for patients who have been newly diagnosed with advanced ovarian, fallopian tube, or primitive peritoneal cancer. It is specifically for patients who do not have a BRCA gene mutation. The role of Olaparib in this trial is to help prevent the cancer from coming back after the initial treatment. It works by blocking certain enzymes in the cancer cells, which can help stop the cancer from growing and spreading. This medication is taken orally, meaning it is swallowed in the form of a pill. The trial aims to see how effective Olaparib is in keeping the cancer from progressing and to understand more about how different patient and tumor characteristics might affect the treatment's success.

What is already known about the treatment

Olaparib – Olaparib is administered orally in the form of tablets and is currently being studied as a maintenance therapy for patients with newly diagnosed BRCA wild-type advanced ovarian, fallopian tube, and primitive peritoneal cancer. It is a well-researched medication in medical literature, particularly for its role in prolonging progression-free survival (PFS) in cancer patients. The main therapeutic indication for Olaparib is to help maintain the condition of patients after initial cancer treatment. At the molecular level, Olaparib works by inhibiting an enzyme called PARP, which helps repair damaged DNA in cells; by blocking this enzyme, the medication prevents cancer cells from repairing themselves, leading to their death. Olaparib is classified as a PARP inhibitor in pharmacology.

Investigated diseases

BRCA wild-type advanced ovarian, fallopian tube, and primary peritoneal cancer – This disease involves the growth of cancerous cells in the ovaries, fallopian tubes, or the lining of the abdominal cavity, known as the peritoneum. It is characterized by the absence of mutations in the BRCA genes, which are often linked to hereditary breast and ovarian cancers. The cancer typically progresses by spreading from the original site to nearby tissues and organs. As it advances, it may cause symptoms such as abdominal bloating, pain, and changes in bowel habits. The disease can also lead to the accumulation of fluid in the abdomen, known as ascites. Over time, it may spread to distant organs, complicating the condition further.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516839-27-00Protocol codeMITO 35aEstimated enrolment200 patientsSponsorIRCCS Istituto Nazionale Tumori Fondazione Pascale

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