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Study for Patients with BRCA Mutated Ovarian, Breast, Pancreatic, Prostate, and Endometrial Cancers Continuing Olaparib Treatment

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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 patients with certain types of cancer, including BRCA Mutated Ovarian Cancer, Metastatic Breast Cancer, Platinum Sensitive Relapsed Ovarian Cancer, gBRCA mutated metastatic pancreatic cancer, prostate cancer, and endometrium cancer. The study involves a medication called Olaparib, which is available in the form of film-coated tablets. Olaparib is a chemical substance used to treat these cancers, and it is also known by its code name, AZD2281.

The purpose of this study is to continue providing treatment to patients who have completed a previous cancer study with Olaparib and are still benefiting from it. The study aims to ensure the safety and tolerability of the ongoing treatment. Patients will continue to receive Olaparib if they are judged by their doctor to be benefiting from the treatment. The study will monitor the patients' health and any side effects that may occur during the treatment period.

Participants in this study will take Olaparib tablets orally, with the treatment period lasting up to 123 days. The study will keep track of any serious side effects or important medical events that happen up to 30 days after the last dose of the study drug. This trial is designed to help patients who are already experiencing positive effects from Olaparib to continue their treatment safely.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after completing a previous oncology study with olaparib and being assessed by the investigator as benefiting from continued treatment.

    Eligibility requires a signed and dated informed consent form and ongoing clinical benefit from a prior study with an AstraZeneca compound.

  2. Step 2

    Treatment administration

    The treatment involves taking Lynparza film-coated tablets, available in 100 mg and 150 mg doses.

    The tablets are taken orally. The specific dosage and frequency are determined by the healthcare provider based on individual needs.

  3. Step 3

    Monitoring and safety

    The main objective is to provide continuous treatment while monitoring safety and tolerability.

    Serious adverse events (SAEs) and adverse events of special interest (AESIs) are monitored until 30 days after the last dose of the study drug.

  4. Step 4

    Study duration

    The estimated end date for the study is December 30, 2030.

    The study aims to ensure that patients continue to benefit from the treatment throughout its duration.

Who can join the trial?

5 criteria

  • The patient must provide a signed and dated written document called an Informed Consent Form (ICF), which shows they agree to participate in the study.
  • The patient must currently be benefiting from treatment in a previous study with a medication from AstraZeneca, as determined by the study doctor.
  • The patient must have been part of a previous cancer study with an AstraZeneca medication called olaparib and must still be benefiting from this treatment. The previous study could have been open (where both the patient and doctor know the treatment) or blinded (where the treatment is unknown to the patient or doctor until the study ends).
  • The study is open to both male and female patients.
  • The study includes patients who may be considered part of a vulnerable population, meaning they might need extra protection or care.

Who cannot join the trial?

10 criteria

  • Patients who do not have a mutation in the BRCA gene. The BRCA gene is related to breast and ovarian cancer risk.
  • Patients who do not have epithelial ovarian cancer. This is a type of cancer that starts in the cells on the surface of the ovary.
  • Patients who do not have metastatic breast cancer. This means the cancer has spread to other parts of the body.
  • Patients who do not have platinum-sensitive relapsed ovarian cancer. This refers to ovarian cancer that responds to platinum-based chemotherapy after it has returned.
  • Patients who do not have gBRCA mutated metastatic pancreatic cancer. This is pancreatic cancer with a specific genetic mutation that has spread to other parts of the body.
  • Patients who do not have prostate cancer. This is cancer that occurs in the prostate, a small gland in men that produces seminal fluid.
  • Patients who do not have endometrium cancer. This is cancer that starts in the lining of the uterus.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial group.
  • Patients who are not considered part of a vulnerable population as defined by the study.
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Investigated drugs

Olaparib is a medication used in this clinical trial. It is designed to help patients who have completed a previous oncology study and are still benefiting from the treatment. Olaparib works by interfering with the cancer cells' ability to repair their DNA, which can help to slow down or stop the growth of cancer. This trial aims to continue providing Olaparib to patients who are experiencing positive effects, while also monitoring their safety and how well they tolerate the medication.

What is already known about the treatment

Olaparib – Olaparib is administered orally in the form of tablets or capsules. It is currently recognized in medical literature as a treatment for certain types of cancers, particularly those with BRCA mutations. The main therapeutic indications include BRCA-mutated ovarian cancer, metastatic breast cancer, and prostate cancer, among others. 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 pharmacologically as a PARP inhibitor.

Investigated diseases

  • BRCA Mutated Ovarian Cancer

    This type of ovarian cancer occurs in individuals with mutations in the BRCA1 or BRCA2 genes. These mutations can lead to the development of cancer in the cells of the ovaries. The disease often progresses with the growth of tumors in the ovarian tissue, which may spread to other parts of the body if not managed.

  • Epithelial Ovarian Cancer

    This is the most common form of ovarian cancer, originating in the layer of cells covering the ovaries. It typically begins with abnormal cell growth in the ovarian epithelium. As the disease progresses, these cells can form tumors and potentially spread to nearby organs.

  • Metastatic Breast Cancer

    Also known as stage IV breast cancer, this condition occurs when cancer cells from the breast spread to other parts of the body. The disease progresses as these cells invade distant organs such as the bones, liver, or lungs. It is characterized by the growth of secondary tumors in these areas.

  • Platinum Sensitive Relapsed Ovarian Cancer

    This type of ovarian cancer refers to cases where the disease returns after initial treatment with platinum-based chemotherapy. The cancer is considered "platinum-sensitive" if it responds to this treatment again. The progression involves the recurrence of tumors in the ovaries or other areas.

  • gBRCA Mutated Metastatic Pancreatic Cancer

    This form of pancreatic cancer is associated with inherited mutations in the BRCA1 or BRCA2 genes. It progresses as cancer cells spread from the pancreas to other parts of the body. The disease is marked by the development of tumors in the pancreas and potentially other organs.

  • Prostate Cancer

    This cancer develops in the prostate gland, which is part of the male reproductive system. It often begins with slow-growing tumors that may not cause symptoms initially. As it progresses, the cancer can spread to nearby tissues or distant parts of the body.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512982-15-00Protocol codeD0817C00098Estimated enrolment188 patientsSponsorAstraZeneca AB

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