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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05303532




Registration number
NCT05303532
Ethics application status
Date submitted
4/02/2022
Date registered
31/03/2022

Titles & IDs
Public title
Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Durvalumab
Scientific 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
Secondary ID [1] 0 0
2021-003031-29
Secondary ID [2] 0 0
D4191C00137
Universal Trial Number (UTN)
Trial acronym
ROSY-D
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Durvalumab

Experimental: Durvalumab - Participants will receive durvalumab.


Treatment: Drugs: Durvalumab
Fixed dose of 1500 mg via IV infusion upon enrollment visit and every 4 weeks thereafter.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with serious adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Timepoint [1] 0 0
From baseline up to follow up at 90 days after the last dose of study drug.

Eligibility
Key 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 AstraZeneca parent study using an AstraZeneca 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.
* Patient can receive durvalumab as a fixed dose of 1500 mg quarterly 4 weeks at study entry.

There are no additional inclusion criteria for the ROSY-D sub-study.
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 (increase in the severity of the disease under study and/or increases in the symptoms of a patient's condition attributable to the disease, as assessed and documented by the Investigator. Physician-defined progression can be radiological [example: Response Evaluation Criteria in Solid Tumours] progression or clinical 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, per Toxicity Dose Modification and TMGs for Immune- mediated, Infusion-related, and Non-Immune-mediated Reactions Guidelines of the parent study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
7/01/2026
Actual
Sample size
Target
61
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Box Hill
Recruitment hospital [2] 0 0
Research Site - Melbourne
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
New York
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United States of America
State/province [3] 0 0
Tennessee
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United States of America
State/province [4] 0 0
Texas
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Argentina
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Rosario
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Belgium
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Charleroi
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Brazil
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Barretos
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Brazil
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Porto Alegre
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Brazil
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São José do Rio Preto
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Bulgaria
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Sofia
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Canada
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Ontario
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China
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Beijing
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China
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Changsha
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China
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Hangzhou
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China
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Jinan
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China
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Nanjing
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China
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Shanghai
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China
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Shijiazhuang
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China
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Wenzhou
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China
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Xi'an
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China
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Xiamen
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Czechia
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Olomouc
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France
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Besançon Cedex
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France
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Bordeaux Cedex
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France
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Brest
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France
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Lyon
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Marseille
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Montpellier
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Rennes
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France
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Rouen
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France
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Saint Herblain
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France
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Strasbourg
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Toulouse
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France
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Tours CEDEX
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France
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Villejuif
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Germany
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Guetersloh
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Germany
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Muenster
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Greece
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Athens
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Hungary
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Budapest
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Hungary
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Gyor
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Hungary
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Székesfehérvár
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India
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Chennai
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Italy
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Arezzo
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Italy
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Bari
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Italy
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Catania
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Italy
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Meldola
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Italy
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Milano
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Italy
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Milan
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Italy
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Modena
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Italy
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Padova
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Italy
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Pisa
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Italy
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Roma
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Japan
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Bunkyo-ku
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Japan
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Fukuoka-shi
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Japan
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Kanazawa-shi
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Japan
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Koto-ku
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Japan
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Nagoya-shi
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Japan
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Okayama-shi
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Japan
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Saga-shi
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Japan
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Sunto-gun
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Korea, Republic of
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Busan
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Korea, Republic of
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Gwangju
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Korea, Republic of
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Seoul
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Malaysia
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Kuching
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Mexico
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Aguascalientes
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Mexico
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Mexico City
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Mexico
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Mérida
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Philippines
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Quezon City
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Poland
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Bialystok
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Bydgoszcz
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Elblag
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Olsztyn
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Szczecin
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Warszawa
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Lódz
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Romania
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Suceava
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Russian Federation
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Moscow
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Novosibirsk
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Russian Federation
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Omsk
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saint-Petersburg
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Singapore
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Singapore
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Barcelona
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Girona
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Madrid
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Marbella
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Spain
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Santiago de Compostela
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Spain
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Valencia
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Switzerland
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Lausanne
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei City
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Taiwan
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Taoyuan
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Thailand
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Bangkok
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Thailand
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Chiang Mai
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Thailand
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Hat Yai
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Turkey
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Ankara
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Turkey
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Bursa
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Çankaya
Country [104] 0 0
Ukraine
State/province [104] 0 0
Chernivtsi
Country [105] 0 0
Ukraine
State/province [105] 0 0
Dnipro
Country [106] 0 0
Ukraine
State/province [106] 0 0
Ivano-Frankivsk
Country [107] 0 0
Ukraine
State/province [107] 0 0
Kyiv
Country [108] 0 0
Ukraine
State/province [108] 0 0
Uzhhorod
Country [109] 0 0
Ukraine
State/province [109] 0 0
Vinnytsia
Country [110] 0 0
United Kingdom
State/province [110] 0 0
London
Country [111] 0 0
United Kingdom
State/province [111] 0 0
Sheffield
Country [112] 0 0
Vietnam
State/province [112] 0 0
Hanoi
Country [113] 0 0
Vietnam
State/province [113] 0 0
Ho Chi Minh city
Country [114] 0 0
Vietnam
State/province [114] 0 0
Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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 document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05303532