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

Study Overview
=================
Brief 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.

Detailed Description
-----------------
ROSY-O is an open label, non-randomised, multicentre,international trial for patients who have completed a parent study using olaparib and who are deriving clinical benefit from continued treatment as judged by the Investigator. Patients will be rolled-over from the parent study and will continue the study indefinitely, until they meet one of the treatment discontinuation criteria

Official Title
-----------------
Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib and Are Judged by the Investigator to Clinically Benefit From Continued Treatment

Conditions
-----------------
Ovarian Cancer, Breast Cancer

Intervention / Treatment
-----------------
* Drug: Olaparib


Participation Criteria
=================
Eligibility Criteria
-----------------
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). Concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. Permanent discontinuation from the parent study due to toxicity or disease progression. Local access to commercially-available drug at no cost to the patient is permitted by local regulation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Olaparib<br>Treatment | Drug: Olaparib<br>* 300 mg olaparib (2×150 mg tablets) twice daily<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety follow up | Serious adverse events and adverse events of special interest reported until 30 days after the last dose of study drug. | Baseline up to approximately 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HER2-ve metastatic, BRCA mutations, Cancer