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

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What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
IRCCS Humanitas Research Hospital Rozzano Italy
Institut Gustave Roussy Villejuif France
Centr Georges Francois Leclerc Dijon France
Medisprof S.R.L. Cluj Napoca Romania

Other Sites

Site Name City Country Status
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Policlinica De Diagnostic Rapid S.A. Brasov Romania
Centre Antoine Lacassagne Nice France
Rigshospitalet Copenhagen Denmark
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Centre Hospitalier Universitaire De Poitiers Poitiers France
Bon Secours Hospital Cork Cork Ireland
Adelaide And Meath Hospital Dublin Ireland
Focus Lab Plus S.R.L. Bucharest Romania
Hhzbed Hjaujaio Herlev Denmark
Aeslxqr Okbsjjgfpwj Uoadscupiatdp Sclqju Siena Italy
Sd Vizhlonivkegahh Uvuskdjgwv Hngahrbw Dublin Ireland
Hulmshwn Vrlc dlritgow Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Not recruiting
17.01.2019
France France
Not recruiting
17.01.2019
Ireland Ireland
Not recruiting
17.01.2019
Italy Italy
Not recruiting
17.01.2019
Romania Romania
Not recruiting
17.01.2019
Spain Spain
Not recruiting
17.01.2019

Trial locations

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.

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 ID:
2022-500797-34-00
Protocol code:
MK-7339-002
NCT ID:
NCT03742895
Trial Phase:
Therapeutic exploratory (Phase II)

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