Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2 Study of Olaparib Monotherapy in Participants with Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer

This research study, called a Phase 2 trial, is looking at a medication named Olaparib. It's for adults with advanced cancer that has specific genetic changes known as Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD). Previous treatments for their cancer may not have worked as hoped. The main goal is to find out if Olaparib can make tumours smaller. Researchers will also look at how long people respond to the treatment, how long people live, how long they stay free of cancer progression, and any side effects. This helps scientists understand if Olaparib could be a useful new treatment option for certain cancers.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

22 Feb 2023

Treatment of participants with positive cancer for HRRm or HRD.

What is this study about?

This study is a Phase 2 clinical trial, which means it's one of the earlier steps in testing new medicines. The main aim is to see how well a drug called Olaparib works in people with advanced cancer. Advanced cancer means the cancer may have spread or come back after previous treatments. The study is specifically looking for people whose cancer has particular genetic changes, known as HRRm or HRD positive. These genetic changes can sometimes make cancer cells more vulnerable to certain types of drugs, like Olaparib.

Researchers want to find out if Olaparib can shrink tumours, which is called an 'Objective Response Rate'. This is the main thing they are measuring. They are also curious about other important things, like how long the tumour shrinkage lasts (Duration of Response), how long people live after starting the treatment (Overall Survival), and how long before the cancer starts to grow or spread again (Progression Free Survival). These measurements help doctors understand the potential benefits of the drug.

Beyond how well the drug works, the study also pays close attention to safety. Researchers will be carefully tracking any side effects (Adverse Events) that people experience, and if anyone needs to stop the treatment because of these side effects. They're also looking at specific markers, like CA-125 for some cancers or PSA for prostate cancer, to see if these change with treatment. Everything learned from this study will help decide if Olaparib should be tested in larger studies and potentially become a standard treatment for certain types of cancer in the future.

Key takeaways

This study is testing Olaparib for advanced cancer with specific genetic changes.
It aims to see if the drug can shrink tumours and how long those effects last.
Patient safety and side effects will be closely watched.
Participation involves regular hospital visits for monitoring and taking the study drug.
You can stop participating at any time.
This is a Phase 2 trial, meaning it's an earlier stage of testing a new treatment.

Who may be eligible?

To join this study, you need to be at least 18 years old. Both men and women can take part. You must have advanced cancer, and your doctors will need to check if your cancer has specific genetic changes, called HRRm or HRD positive, which are important for this study.

Before you can join, the study team will carry out some tests and checks to make sure the study is suitable and safe for you. This often includes looking at your general health and previous cancer treatments. You will have had previous treatments for your cancer already.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have advanced cancer?
Has your cancer been previously treated?
Has your doctor confirmed your cancer has the HRRm or HRD genetic changes?
Are you able to attend regular hospital visits for treatment and monitoring?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the study drug, Olaparib. This will likely be in tablet or capsule form, and you will take it regularly as instructed by the study team. You'll have regular visits to the hospital or clinic so the doctors and nurses can monitor your health, check for any side effects, and see how well the treatment is working. These visits might include blood tests, scans, and physical examinations.

Taking part involves a commitment to these regular visits and careful follow-up. The team will explain exactly how often you need to come in and for how long. You'll be closely monitored throughout your time on the study and even after you finish taking the drug, to understand the long-term effects. The total duration of your participation will depend on how you respond to the treatment and the study's follow-up plan, but it generally involves several months of active treatment and follow-up.

Potential risks and benefits

Taking part in any clinical trial comes with potential benefits and risks. You might benefit from a new treatment that isn't yet widely available, and your health will be carefully monitored by a dedicated medical team. However, Olaparib could have side effects, which the study team will explain to you in detail. There's also no guarantee that the treatment will work for your cancer, or that it will work better than standard treatments. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Ireland
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Unverified
Denmark
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Unverified
Spain
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Unverified
Italy
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Unverified
Romania
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Unverified
France

Common questions

What is Olaparib?

Olaparib is a medication being tested in this study to see if it can help treat certain types of advanced cancer. It belongs to a group of drugs that target specific weaknesses in cancer cells.

What does 'HRRm or HRD positive' mean?

This refers to specific genetic changes or weaknesses in your cancer cells. The study is particularly interested in people whose cancer has these changes, as Olaparib might be more effective for them.

Is this a new treatment?

Olaparib is a tested drug, but for the specific types of cancer being studied here, it's being explored in this Phase 2 trial to understand its full potential and safety.

How long will I be on the study?

The length of your participation can vary. You will receive the treatment for as long as it is helping you and you are tolerating it, followed by a period of close monitoring by the study team.

Can I leave the study at any time?

Yes, absolutely. You are free to withdraw from the study at any point, and your decision will not affect your ongoing medical care.