Active not recruitingPHASE3INTERVENTIONAL

Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib

This study, called ROSY-O, is for patients with ovarian or breast cancer who are currently taking a medication called olaparib as part of an existing clinical trial. It's designed for those who are still getting a clear benefit from olaparib treatment when their current study is due to finish. The main goal is to allow these patients to continue receiving olaparib without interruption. This ensures that if the medication is working well for them, they can keep using it for as long as their doctor believes it's helping and they are not experiencing severe side effects. Participants will continue in this new study indefinitely, unless their health changes, severe side effects occur, or other reasons for stopping treatment arise.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

185

Start

04 Aug 2020

Estimated completion

06 Apr 2027

Ovarian Cancer Breast Cancer

What is this study about?

This study is called ROSY-O, which stands for 'Roll Over StudY for Patients.' It's specifically for people who have ovarian cancer or breast cancer and are already taking a medicine called olaparib as part of another research study. Sometimes, studies come to an end, even if the treatment is still helping patients. This 'roll-over' study is designed as a way for these patients to seamlessly continue receiving olaparib if their doctor believes it's still benefiting them.

The main idea behind ROSY-O is to ensure that if olaparib is working well for a patient in one study, they don't have to stop taking it simply because that study is finishing. It provides a way to carry on with their treatment without a break, as long as it continues to be helpful and safe for them. This is especially important for ongoing conditions like cancer, where continuous effective treatment is key.

This study is for adults aged 18 to 99 and includes all genders. It will run in many different hospitals around the world. The study is 'open-label,' meaning both you and your doctors will know you are receiving olaparib. It's also 'non-randomised,' which means you won't be put into different groups by chance; everyone in this study will continue to receive olaparib.

Key takeaways

This study helps patients continue taking olaparib if it's working for them.
It's for people with ovarian or breast cancer already in an olaparib study.
You will know you are receiving the active drug (olaparib).
Participation ensures continuous access to your beneficial treatment.
You can stop participating at any time.
Your doctor will regularly monitor your health and side effects.

Who may be eligible?

To be part of this study, you must meet certain requirements. Firstly, you need to have been taking olaparib in another research study run by AstraZeneca (AZ), and your doctor must believe that the treatment is still helping you. This applies even if your previous study was 'blinded' (meaning you didn't know if you were getting the drug or a placebo) but has now ended and the information has been revealed.

There are also some reasons why you wouldn't be able to join. For example, if you had severe side effects from olaparib (Grade 3 or higher) that weren't resolved when your previous study ended and caused you to stop treatment, you wouldn't be eligible. Also, if you're taking other medications that shouldn't be mixed with olaparib, or if you've already had to stop your olaparib treatment permanently in the previous study due to side effects or your cancer getting worse, you can't join this study.

Finally, if the olaparib drug is already easily available to you at no cost in your local area, then you wouldn't be able to join this study, as its purpose is to provide continued access for those who otherwise wouldn't have it after their parent study finishes.

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 currently taking olaparib in an AstraZeneca clinical research study?
Does your doctor believe that olaparib is still helping you with your cancer?
Did you *not* have to permanently stop your previous olaparib study because of severe side effects or your cancer getting worse?
Are you aged 18 or older?
Is olaparib *not* easily available for free in your local area outside of a study?

Answer every question to see your result.

What does participation involve?

If you join the ROSY-O study, you will continue to take olaparib, just as you were doing in your previous study. Your doctors will regularly check your health, any side effects you might be experiencing, and how well the treatment is working. These checks will involve regular clinic visits, physical examinations, and blood tests, similar to what you've likely experienced in your past study. You will continue with this treatment for an indefinite period, as long as it continues to help you, you don't experience severe side effects, and your doctor thinks it's still the best option for you. The study will only end for you if these conditions change, or if you or your doctor decide it's best to stop.

Potential risks and benefits

The main potential benefit of joining this study is that you can continue receiving olaparib, which your doctor believes is still helping you, without a break when your current study ends. This ensures ongoing access to a treatment that is effective for you. As with any medication, there are potential risks and side effects associated with olaparib; these will be the same ones you may have already experienced or been told about in your previous study. Your medical team will discuss these with you in detail. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (107)

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

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Boca Raton, United States
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Towson, United States
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Detroit, United States
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Minneapolis, United States
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Basking Ridge, United States
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Hackensack, United States
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New York, United States
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The Bronx, United States
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Philadelphia, United States
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Pittsburgh, United States
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Willow Grove, United States
Research Site
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Providence, United States

Common questions

What is the main goal of the ROSY-O study?

The main goal is to allow patients who are already taking olaparib in another study and are benefiting from it, to continue their treatment after their current study ends.

Who can join this study?

Adults aged 18 to 99 with ovarian or breast cancer who are currently taking olaparib in another AstraZeneca study and are still benefiting from it, as judged by their doctor.

Will I know if I'm getting the actual drug?

Yes, this is an 'open-label' study, which means both you and your doctors will know you are receiving olaparib.

How long will I be in the study?

You will continue to receive treatment indefinitely, as long as it continues to help you and your doctor believes it's safe for you to continue.

What happens if I experience serious side effects?

If you develop serious side effects, your doctor may decide to pause or stop your treatment, or you can choose to stop at any time.