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

Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05629234
• Other study ID #: D5161N00007
• Status: Recruiting
• Phase: Phase 3
• Start date: May 8, 2023
• Est. completion date: February 21, 2025

Study information

• Verified date: January 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 37
• Est. completion date: February 21, 2025
• Est. primary completion date: February 21, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Neoplasms

Intervention

Drug:
• Osimertinib
Osimertinib (dose range of 40 mg to 240 mg orally, once daily)

Locations

Country	Name	City	State
China	Research Site	Beijing
China	Research Site	Chongqing
China	Research Site	Shanghai
China	Research Site	Yangzhou
China	Research Site	Zhengzhou
France	Research Site	Villejuif Cedex
Korea, Republic of	Research Site	Cheongju-si
Korea, Republic of	Research Site	Dong-gu
Korea, Republic of	Research Site	Goyang-si
Korea, Republic of	Research Site	Seongnam-si
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Malaysia	Research Site	Georgetown
Malaysia	Research Site	Johor Bahru
Malaysia	Research Site	Kuantan
Malaysia	Research Site	Kuching
Poland	Research Site	Szczecin
Taiwan	Research Site	Kaohsiung
Taiwan	Research Site	Taichung
Taiwan	Research Site	Tainan
Taiwan	Research Site	Tainan
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taoyuan
Thailand	Research Site	Bangkok
United Kingdom	Research Site	Nottingham

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Parexel

Countries where clinical trial is conducted

China,  France,  Korea, Republic of,  Malaysia,  Poland,  Taiwan,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)	Safety and tolerability of osimertinib will be assessed.	Until 90 days after the last dose of study treatment