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

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: NCT05303532
Recruitment Status : Enrolling by invitation
First Posted : March 31, 2022
Last Update Posted : August 3, 2022
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
The rationale of the ROSY-D study is to continue to provide study treatment for patients who have participated in a parent study with Durvalumab 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
Non-Small Cell Lung Cancer Urothelial Carcinoma Drug: Durvalumab Phase 3

Detailed Description:
ROSY-D is an open label, non-randomised, multicentre, international trial for patients who have completed a parent study using durvalumab 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 : 61 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ROSY-D: Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Durvalumab and Are Judged by the Investigator to Clinically Benefit From Continued Treatment
Actual Study Start Date : April 19, 2022
Estimated Primary Completion Date : November 8, 2024
Estimated Study Completion Date : November 8, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab

Arm Intervention/treatment
Experimental: Durvalumab
Participants will receive durvalumab.
Drug: Durvalumab
Fixed dose of 1500 mg via IV infusion upon entry and every 4 weeks thereafter.




Primary Outcome Measures :
  1. Number of participants with serious adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 [ Time Frame: From baseline up to follow up at 90 days after the last dose of study drug. ]
    To monitor safety and tolerability of continuous study treatment to patients who continue to benefit at the end of the clinical trial by measuring the primary outcome of Serious Adverse Events (SAEs).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

The Core Protocol inclusion criteria are:

  • Provision of signed and dated, written Informed Consent Form (ICF).
  • Patient is currently deriving clinical benefit, as judged by the investigator, from continued treatment in an AZ parent study using an AZ compound that has met its endpoints, or has otherwise stopped, or the patient has reached maximum treatment duration allowed in the parent study's protocol.

There are no additional inclusion criteria for the ROSY-D sub-study.

Exclusion Criteria:

The Core Protocol exclusion criteria are.

  • 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 as permitted by local/country regulation.

The additional exclusion criteria for the ROSY-D sub-study are:

  • Active infection including Coronavirus disease 2019 (Polymerase chain reaction confirmed and/or clinically suspected), tuberculosis, hepatitis B (known positive Hepatitis B virus (HBV) surface antigen result), hepatitis C, or Human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies).
  • Male or female patients of reproductive potential who are not willing to employ effective birth control from study inclusion up to 90 days after the last dose of durvalumab monotherapy.
  • Ongoing, unresolved, Grade 2 toxicity with an inability to reduce corticosteroid to a dose of ≤ 10 mg of prednisone per day (or equivalent) within 12 weeks after last dose of study treatment/study regimen, as per Toxicity Dose Modification and TMGs for Immune- mediated, Infusion-related, and Non-Immune-mediated Reactions Guidelines of the parent study.

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): NCT05303532


Locations
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Canada, Ontario
Research Site
Newmarket, Ontario, Canada, L3Y 2P9
France
Research Site
Besançon Cedex, France, 25030
Research Site
Bordeaux Cedex, France, 33076
Research Site
Brest, France, 29200
Research Site
Dijon cedex, France, 21079
Research Site
Lyon, France, 69373
Research Site
Marseille, France, 13005
Research Site
Montpellier, France, 34090
Research Site
Pierre Benite, France, 69495
Research Site
Rouen, France, 76031
Research Site
Saint Herblain, France, 44805
Research Site
Strasbourg, France, 67091
Research Site
Tours CEDEX, France, 37044
Research Site
Villejuif, France, 94805
Germany
Research Site
Guetersloh, Germany, 33332
Research Site
Muenster, Germany, 48149
Italy
Research Site
Arezzo, Italy, 52100
Research Site
Catania, Italy, 95126
Research Site
Meldola, Italy, 47014
Research Site
Milan, Italy, 20141
Research Site
Padova, Italy, 35128
Research Site
Pisa, Italy, 56126
Research Site
Roma, Italy, 00128
Research Site
Roma, Italy, 00152
Korea, Republic of
Research Site
Busan, Korea, Republic of, 49241
Research Site
Seoul, Korea, Republic of, 6351
United Kingdom
Research Site
Sheffield, United Kingdom, S10 2SJ
Sponsors and Collaborators
AstraZeneca
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT05303532    
Other Study ID Numbers: D4191C00137
2021-003031-29 ( EudraCT Number )
First Posted: March 31, 2022    Key Record Dates
Last Update Posted: August 3, 2022
Last Verified: August 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 deidentified 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:
Cancer
Oncology
Clinically Benefit
Roll Over StudY
Durvalumab
Additional relevant MeSH terms:
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Neoplasms
Carcinoma, Transitional Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Durvalumab
Antineoplastic Agents, Immunological
Antineoplastic Agents