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Study of Olaparib for Patients with Advanced Cancer Having HRRm or HRD Mutations

Verified siteInvestigationalNo placebo
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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 on certain types of advanced cancer. The cancers being studied are those that have specific genetic characteristics known as Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD). These genetic traits can affect how cancer cells repair themselves, and the study aims to see how well Olaparib works in treating these cancers.

The purpose of the study is to evaluate how patients with these specific types of cancer respond to treatment with Olaparib. Participants in the study will receive Olaparib in the form of a film-coated tablet, which they will take orally. The study will monitor the participants over a period to see how their cancer responds to the treatment. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of Olaparib against no treatment.

Throughout the study, researchers will assess various outcomes, such as how long the response to the treatment lasts, overall survival rates, and any side effects experienced by participants. The study will also look at specific responses in different types of cancer, such as prostate cancer, and how the treatment affects cancer markers like Prostate-specific Antigen (PSA). The goal is to gather information that could help improve treatment options for patients with these genetic cancer types 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

    Joining the study

    Upon joining the study, you will be informed about the trial's purpose and procedures. You will be asked to provide consent to participate.

    You will undergo initial assessments to confirm eligibility, including medical history review and physical examination.

  2. Step 2

    Initial assessments

    You will provide blood and tissue samples for testing. These samples help determine specific genetic markers related to your cancer.

    A biopsy may be required to obtain a sample of your tumor tissue.

  3. Step 3

    Treatment phase

    You will begin taking the medication olaparib in the form of a film-coated tablet. This medication is taken orally.

    The dosage and frequency of olaparib will be specified by the study team, and you will be instructed on how to take it correctly.

  4. Step 4

    Regular monitoring

    Throughout the study, you will have regular visits to monitor your health and response to the treatment.

    These visits may include physical exams, blood tests, and imaging studies to assess the progress of your cancer.

  5. Step 5

    Evaluation of response

    Your response to the treatment will be evaluated using specific criteria to measure changes in your cancer.

    The study team will review your results to determine the effectiveness of the treatment.

  6. Step 6

    Completion of treatment

    Once the treatment phase is complete, you will undergo final assessments to evaluate your overall health and the impact of the treatment.

    You may be asked to continue follow-up visits to monitor your long-term health.

Who can join the trial?

13 criteria

  • The participant must have a type of cancer that can be measured by doctors using specific guidelines.
  • If the participant has breast cancer, it must be confirmed by a test and show that the cancer has spread to other parts of the body.
  • If the participant has breast cancer, they must have a known or suspected harmful change in the BRCA1 or BRCA2 genes, which are linked to breast cancer risk. They should not have inherited these changes from their parents. Tests can be done at the study site or another location. Blood and tissue samples are required from all participants.
  • If the participant has breast cancer, they must have been treated with certain cancer drugs called anthracyclines and taxanes, unless they cannot take these drugs for medical reasons.
  • If the participant has breast cancer that is sensitive to hormones, they must have tried at least one hormone therapy and it did not work, or the doctor thinks hormone therapy is not suitable for them.
  • The participant must be able to provide a new sample of their tumor or an older sample that was preserved in a specific way.
  • The participant must have a life expectancy of at least 3 months.
  • The participant must have a good level of daily functioning, as measured by a standard scale used by doctors.
  • Male participants must agree to use birth control during the study and for at least 95 days after the last dose of the study treatment. They must also agree not to donate sperm during this time.
  • Female participants must not be pregnant or breastfeeding. They must either not be able to become pregnant or agree to use a highly effective birth control method or abstain from heterosexual intercourse during the study and for at least 180 days after the last dose. They must also agree not to donate eggs during this time.
  • The participant must have organs that are working well enough to participate in the study.
  • If the participant has a type of cancer other than breast or ovarian cancer, it must be confirmed by a test and show that the cancer has spread or cannot be removed by surgery. The cancer must not be treatable with standard treatments, and the participant must have tried standard treatments that are known to help but did not work or could not be tolerated.
  • If the participant has a type of cancer other than breast or ovarian cancer, they must have a known or suspected harmful change in genes involved in homologous recombination repair (HRR) or have a condition called homologous recombination deficiency (HRD), which affects how cells repair themselves.

Who cannot join the trial?

5 criteria

  • Participants who do not have a positive test for **HRRm** or **HRD**. These are specific genetic markers related to cancer.
  • Participants who are not within the specified age range for the study.
  • Participants who are not part of the specified clinical trial groups.
  • Participants who are not male or female, as both genders are included in the study.
  • Participants who are considered part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Olaparib is a medication used in this clinical trial. It is designed to treat certain types of advanced cancer by targeting and interfering with the cancer cells' ability to repair their DNA. This can help to stop the growth of cancer cells and may lead to their death. Olaparib is particularly used for cancers that have specific genetic mutations, making it a targeted therapy option for patients with these mutations. In this trial, the effectiveness of Olaparib is being evaluated in patients who have already received other treatments for their cancer.

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 advanced cancers that have specific genetic mutations or deficiencies related to DNA repair, known as HRRm or HRD. The main therapeutic use of Olaparib is for treating cancers with these genetic characteristics. 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 as a PARP inhibitor in pharmacology.

Investigated diseases

Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. It often progresses slowly and may not show symptoms in the early stages. As it advances, it can cause urinary problems, pelvic discomfort, and erectile dysfunction. The cancer can spread to nearby tissues or other parts of the body, such as bones and lymph nodes. The progression is typically monitored through prostate-specific antigen (PSA) levels and imaging tests. The rate of progression varies among individuals, with some experiencing rapid growth and others having a more indolent course.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-500797-34-00Protocol codeMK-7339-002Estimated enrolment108 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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