| CTRI Number |
CTRI/2024/01/061411 [Registered on: 12/01/2024] Trial Registered Prospectively |
| Last Modified On: |
11/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Roll Over StudY for Patients Who Have Completed & Benefitted from a Previous Oncology Study With Durvalumab (ROSY-D) |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2021-003031-29 |
EudraCT |
| D4191C00137, Version 2.0 AMENDMENT 1 dated 24-Aug-2022 |
Protocol Number |
| NCT05303532 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
|
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Annappa Kamath |
| Designation |
Executive Director Project Leadership |
| Affiliation |
PAREXEL International Clinical Research Private Limited |
| Address |
CoWrks, Coworking Spaces Pvt. Ltd. - RMZ Eco World, Ground Floor, Bay Area - Adjacent to Building 6A, Outer Ring Road, Devarabeesanahalli Village
Bangalore Rural
KARNATAKA
560103
India |
| Phone |
919902096914 |
| Fax |
918067723001 |
| Email |
Annappa.Kamath@parexel.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Annappa Kamath |
| Designation |
Executive Director Project Leadership |
| Affiliation |
PAREXEL International Clinical Research Private Limited |
| Address |
CoWrks, Coworking Spaces Pvt. Ltd. - RMZ Eco World, Ground Floor, Bay Area - Adjacent to Building 6A, Outer Ring Road, Devarabeesanahalli Village
KARNATAKA
560103
India |
| Phone |
919902096914 |
| Fax |
918067723001 |
| Email |
Annappa.Kamath@parexel.com |
|
|
Source of Monetary or Material Support
|
| AstraZeneca AB, 151 85 Södertälje, Sweden |
|
|
Primary Sponsor
|
| Name |
AstraZeneca AB |
| Address |
151 85 Södertälje, Sweden |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| PAREXEL International Clinical Research Private Limited |
CoWrks, Coworking Spaces Pvt. Ltd. - RMZ Eco World, Ground Floor, Bay Area – Adjacent to Building 6A, Outer Ring Road, Devarabeesanahalli Village, BENGALURU - 560103, Karnataka, INDIA |
|
|
Countries of Recruitment
|
Argentina
Australia
Brazil
Bulgaria
Canada
China
Czech Republic
France
Germany
Hungary
India
Italy
Japan
Malaysia
Poland
Republic of Korea
Romania
Russian Federation
Singapore
Spain
Switzerland
Taiwan
Thailand
Turkey
Ukraine
United Kingdom
United States of America
Viet Nam |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohamed Zehran Sai Pillai |
Apollo Cancer Centre |
Department of Oncology
No. 320, Padma Complex, Anna salai, Teynampet
Chennai
TAMIL NADU |
04424355003
914424362424
drzehran_s@apollohospitals.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Clinical studies, Apollo Hospitals Enterprise Limited, Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Durvalumab |
Fixed dose of 1500 mg via IV infusion upon enrollment visit and every 4 weeks thereafter |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
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 studys protocol.
There are no additional inclusion criteria for the ROSY-D sub-study
|
|
| ExclusionCriteria |
| Details |
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 or 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 by 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 less than or equal to 10 mg of prednisone per day (or equivalent) within 12 weeks after last dose of study treatment or study regimen, per Toxicity Dose Modification and TMGs for Immune- mediated, Infusion-related, and Non-Immune-mediated Reactions Guidelines of the parent study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To provide continuous study treatment to patients
who continue to benefit at the end of a clinical study,
while monitoring safety and tolerability |
SAEs reported until 90 days after the last dose of
study treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="201"
Sample Size from India="1"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
22/01/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
19/04/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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
The rationale of the ROSY study is to provide continuous study treatment for patients who are continuing to derive clinical benefit from treatment at the end of a clinical trial, as judged by the Investigator, while monitoring safety and tolerability. Patients will be enrolled into the appropriate ROSY study based upon the treatment received in their parent study. The duration of clinical benefit from study treatment for an individual patient can exceed the duration of a clinical trial. To ensure continued supply of treatment to a patient who, as judged by the Investigator, is still receiving benefit when he/she either completes the parent study or when the parent study closes, a roll-over study is the most universally acceptable mechanism for continuing to provide ongoing study treatment.
|