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Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Osimertinib (TAGRISSO) (ROSY-T) (ROSY-T)

Primary Purpose

Cancer

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Osimertinib
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring Cancer, Oncology, Clinically Benefit, Roll Over StudY

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Provision of signed and dated, written Informed Consent Form (ICF). Patient is currently deriving clinical benefit from continued treatment with osimertinib in an AstraZeneca parent study using osimertinib monotherapy which has met its endpoints or has otherwise stopped. Patients should be using adequate contraceptive measures. 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. Exclusion Criteria for the sub-study: 1. Active infection including active hepatitis C and Human immunodeficiency virus (HIV) infection or active uncontrolled Hepatitis B virus (HBV) infection. Screening for chronic conditions is not required. Patients with HBV infection are only eligible if they meet all the following criteria: Demonstrated absence of HCV co-infection or history of HCV co-infection; Demonstrated absence of HIV infection; Patients receiving anti-viral treatment for at least 6 weeks prior to study treatment, HBV DNA is suppressed to < 100 IU/mL, and transaminase levels are below ULN. Patients with a resolved or chronic HBV infection are eligible if they are: Negative for HBsAg and positive for anti-HBc IgG. In addition, patients must be receiving anti-viral prophylaxis for 2 to 4 weeks prior to study treatment and 6 to 12 months (to be determined by hepatologist) post treatment; or Positive for HBsAg, but for > 6 months have had transaminases levels below ULN and HBV DNA levels below < 100 IU/mL (ie, patients are in an inactive carrier state). In addition, patients must be receiving anti-viral prophylaxis for 2 to 4 weeks prior to study treatment. Should participants with HIV infection be included, patients are only eligible if they meet all the following criteria: Undetectable viral RNA load for 6 months CD4+ count of > 350 cells/μL No history of AIDS-defining opportunistic infection within the past 12 months (to be determined by hepatologist) post treatment Stable for at least 4 weeks on anti-HIV medications.

Sites / Locations

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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Osimertinib

Arm Description

Participants will receive Osimertinib

Outcomes

Primary Outcome Measures

Number of patients with Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
Safety and tolerability of osimertinib will be assessed.

Secondary Outcome Measures

Full Information

First Posted
November 17, 2022
Last Updated
June 12, 2023
Sponsor
AstraZeneca
Collaborators
Parexel
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1. Study Identification

Unique Protocol Identification Number
NCT05629234
Brief Title
Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Osimertinib (TAGRISSO) (ROSY-T)
Acronym
ROSY-T
Official Title
ROSY-T: Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Osimertinib and Are Judged by the Investigator to Clinically Benefit From Continued Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2023 (Actual)
Primary Completion Date
February 21, 2025 (Anticipated)
Study Completion Date
February 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Parexel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The rationale of the ROSY-T study is to continue to provide study treatment for patients who have participated in a parent study with osimertinib and who are continuing to derive clinical benefit from treatment at the end of such studies, as judged by the Investigator.
Detailed Description
ROSY-T is an open label, non-randomised, multicentre, international trial for patients who have completed a parent study using osimertinib 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, until they meet one of the treatment discontinuation criteria.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
Keywords
Cancer, Oncology, Clinically Benefit, Roll Over StudY

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Sequential Assignment
Model Description
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Osimertinib
Arm Type
Experimental
Arm Description
Participants will receive Osimertinib
Intervention Type
Drug
Intervention Name(s)
Osimertinib
Other Intervention Name(s)
TAGRISSO
Intervention Description
Osimertinib (dose range of 40 mg to 240 mg orally, once daily)
Primary Outcome Measure Information:
Title
Number of patients with Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
Description
Safety and tolerability of osimertinib will be assessed.
Time Frame
Until 90 days after the last dose of study treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision of signed and dated, written Informed Consent Form (ICF). Patient is currently deriving clinical benefit from continued treatment with osimertinib in an AstraZeneca parent study using osimertinib monotherapy which has met its endpoints or has otherwise stopped. Patients should be using adequate contraceptive measures. 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. Exclusion Criteria for the sub-study: 1. Active infection including active hepatitis C and Human immunodeficiency virus (HIV) infection or active uncontrolled Hepatitis B virus (HBV) infection. Screening for chronic conditions is not required. Patients with HBV infection are only eligible if they meet all the following criteria: Demonstrated absence of HCV co-infection or history of HCV co-infection; Demonstrated absence of HIV infection; Patients receiving anti-viral treatment for at least 6 weeks prior to study treatment, HBV DNA is suppressed to < 100 IU/mL, and transaminase levels are below ULN. Patients with a resolved or chronic HBV infection are eligible if they are: Negative for HBsAg and positive for anti-HBc IgG. In addition, patients must be receiving anti-viral prophylaxis for 2 to 4 weeks prior to study treatment and 6 to 12 months (to be determined by hepatologist) post treatment; or Positive for HBsAg, but for > 6 months have had transaminases levels below ULN and HBV DNA levels below < 100 IU/mL (ie, patients are in an inactive carrier state). In addition, patients must be receiving anti-viral prophylaxis for 2 to 4 weeks prior to study treatment. Should participants with HIV infection be included, patients are only eligible if they meet all the following criteria: Undetectable viral RNA load for 6 months CD4+ count of > 350 cells/μL No history of AIDS-defining opportunistic infection within the past 12 months (to be determined by hepatologist) post treatment Stable for at least 4 weeks on anti-HIV medications.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AstraZeneca Clinical Study Information Center
Phone
1-877-240-9479
Email
information.center@astrazeneca.com
Facility Information:
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
ChongQing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Yangzhou
ZIP/Postal Code
225001
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Villejuif
ZIP/Postal Code
94800
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Cheongju-si
ZIP/Postal Code
28644
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Dong-gu
ZIP/Postal Code
44033
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Seodaemun-gu
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
5505
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
6351
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
6591
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Georgetown
ZIP/Postal Code
10450
Country
Malaysia
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Johor Bahru
ZIP/Postal Code
81100
Country
Malaysia
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Kuantan
ZIP/Postal Code
25100
Country
Malaysia
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Kuching
ZIP/Postal Code
93586
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Szczecin
ZIP/Postal Code
71-455
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Tainan
ZIP/Postal Code
736
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
112201
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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. Yes, indicates that AZ are accepting requests for individual participant data (IPD), but this does not mean all requests will be shared.
IPD Sharing 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 refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing 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.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home

Learn more about this trial

Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Osimertinib (TAGRISSO) (ROSY-T)

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