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Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib (ROSY-O)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04421963
Recruitment Status : Enrolling by invitation
First Posted : June 9, 2020
Last Update Posted : May 31, 2022
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Breast Cancer Drug: Olaparib Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 153 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 4, 2020
Estimated Primary Completion Date : December 19, 2024
Estimated Study Completion Date : December 19, 2024


Arm Intervention/treatment
Experimental: Olaparib
Treatment
Drug: Olaparib
300 mg olaparib (2×150 mg tablets) twice daily




Primary Outcome Measures :
  1. Safety follow up [ Time Frame: Baseline up to approximately 10 years ]
    Serious adverse events and adverse events of special interest reported until 30 days after the last dose of study drug.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female subjects with historically diagnosed relapsed high grade serious or high grade endometrioid ovarian cancer; Patients with HER2-ve metastatic breast cancer with germline or somatic BRCA mutations.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of signed and dated, written ICF.
  2. 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.
  3. 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:

  1. Ongoing, unresolved, Grade 3 or above toxicity requiring interruption of treatment at the time of the termination of the parent study.
  2. Currently receiving treatment with any prohibited medication(s).
  3. Concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
  4. Permanent discontinuation from the parent study due to toxicity or disease progression.
  5. Local access to commercially-available drug at no cost to the patient is permitted by local regulation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04421963


Locations
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Sponsors and Collaborators
AstraZeneca
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04421963    
Other Study ID Numbers: D0817C00098
2019-003777-26 ( EudraCT Number )
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: May 31, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
HER2-ve metastatic
BRCA mutations
Cancer
Additional relevant MeSH terms:
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Olaparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents