Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib (NCT04421963) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib
United States, Belgium, Bulgaria185 participantsStarted 2020-08-04
Plain-language summary
The rationale of the ROSY-O study is to continue to provide study treatment for patients who have participated in a parent study with olaparib and who are continuing to derive clinical benefit from treatment at the end of such studies, as judged by the Investigator.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Provision of signed and dated, written ICF.
. Patient is currently deriving clinical benefit, as judged by the Investigator, from continued treatment in an AZ parent study using an AstraZeneca (AZ) compound that has met its endpoints or has otherwise stopped.
. Patient participating in a prior oncology study with an AZ compound in which they received olaparib and are continuing to receive clinical benefit from treatment; the prior study can be an open-label or blinded study, with unblinding at study close.
Exclusion criteria
. Ongoing, unresolved, Grade 3 or above toxicity requiring interruption of treatment at the time of the termination of the parent study.
. Currently receiving treatment with any prohibited medication(s).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a 'roll-over' study, does that mean I would need to have already been enrolled in a previous olaparib trial to even be considered for this one, and if so, does my history qualify?
2This trial is in Phase 3 and is focused on safety follow-up — what does that mean in practical terms for me, and would I still be receiving olaparib as a treatment or mainly being monitored?
3The trial is listed as 'active, not recruiting' — is there any realistic pathway for me to join, or should we focus our energy on finding an open olaparib study or another treatment option instead?
4Since the primary goal here is tracking long-term safety rather than testing whether olaparib works, what kinds of side effects or risks are they still watching for, and how might those be relevant to my situation with ovarian or breast cancer?
5If this roll-over study isn't an option for me, are there other ways I could access olaparib — such as standard approved use or a different clinical trial — that my care team would recommend exploring?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.