Trial Title:
Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Osimertinib (TAGRISSO) (ROSY-T)
NCT ID:
NCT05629234
Condition:
Cancer
Conditions: Official terms:
Neoplasms
Osimertinib
Conditions: Keywords:
Cancer
Oncology
Clinically Benefit
Roll Over StudY
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Intervention model description:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Osimertinib
Description:
Osimertinib (dose range of 40 mg to 240 mg orally, once daily)
Arm group label:
Osimertinib
Other name:
TAGRISSO
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Provision of signed and dated, written Informed Consent Form (ICF).
2. 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.
3. Patients should be using adequate contraceptive measures.
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.
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Beijing
Zip:
100142
Country:
China
Facility:
Name:
Research Site
Address:
City:
Chongqing
Zip:
400042
Country:
China
Facility:
Name:
Research Site
Address:
City:
Shanghai
Zip:
200433
Country:
China
Facility:
Name:
Research Site
Address:
City:
Yangzhou
Zip:
225001
Country:
China
Facility:
Name:
Research Site
Address:
City:
Zhengzhou
Zip:
450008
Country:
China
Facility:
Name:
Research Site
Address:
City:
Villejuif Cedex
Zip:
94805
Country:
France
Facility:
Name:
Research Site
Address:
City:
Cheongju-si
Zip:
28644
Country:
Korea, Republic of
Facility:
Name:
Research Site
Address:
City:
Dong-gu
Zip:
44033
Country:
Korea, Republic of
Facility:
Name:
Research Site
Address:
City:
Goyang-si
Zip:
10408
Country:
Korea, Republic of
Facility:
Name:
Research Site
Address:
City:
Seongnam-si
Zip:
13620
Country:
Korea, Republic of
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
06591
Country:
Korea, Republic of
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
5505
Country:
Korea, Republic of
Facility:
Name:
Research Site
Address:
City:
Georgetown
Zip:
10450
Country:
Malaysia
Facility:
Name:
Research Site
Address:
City:
Johor Bahru
Zip:
81100
Country:
Malaysia
Facility:
Name:
Research Site
Address:
City:
Kuantan
Zip:
25100
Country:
Malaysia
Facility:
Name:
Research Site
Address:
City:
Kuching
Zip:
93586
Country:
Malaysia
Facility:
Name:
Research Site
Address:
City:
Szczecin
Zip:
70-419
Country:
Poland
Facility:
Name:
Research Site
Address:
City:
Kaohsiung
Zip:
83301
Country:
Taiwan
Facility:
Name:
Research Site
Address:
City:
Taichung
Zip:
40705
Country:
Taiwan
Facility:
Name:
Research Site
Address:
City:
Tainan
Zip:
704
Country:
Taiwan
Facility:
Name:
Research Site
Address:
City:
Tainan
Zip:
736
Country:
Taiwan
Facility:
Name:
Research Site
Address:
City:
Taipei
Zip:
112201
Country:
Taiwan
Facility:
Name:
Research Site
Address:
City:
Taoyuan
Zip:
333
Country:
Taiwan
Facility:
Name:
Research Site
Address:
City:
Nottingham
Zip:
NG5 1PB
Country:
United Kingdom
Start date:
May 8, 2023
Completion date:
February 21, 2025
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Collaborator:
Agency:
Parexel
Agency class:
Industry
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05629234
