Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Osimertinib (TAGRISSO) (ROSY-T)
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Osimertinib Participants will receive Osimertinib |
Drug: Osimertinib
Osimertinib (dose range of 40 mg to 240 mg orally, once daily)
Other Names:
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Outcome Measures
Primary Outcome Measures
- Number of patients with Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs) [Until 90 days after the last dose of study treatment]
Safety and tolerability of osimertinib will be assessed.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Provision of signed and dated, written Informed Consent Form (ICF).
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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.
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Patients should be using adequate contraceptive measures.
Exclusion Criteria:
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Ongoing, unresolved, Grade 3 or above toxicity requiring interruption of treatment at the time of the termination of the parent study.
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Currently receiving treatment with any prohibited medication(s).
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Concurrently enrolled in any other type of medical research judged not to be scientifically, or medically compatible with this study.
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Permanent discontinuation from the parent study due to toxicity or disease progression.
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Local access to commercially-available drug at no cost to the patient is permitted by local regulation.
Exclusion Criteria for the sub-study:
- 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:
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Demonstrated absence of HCV co-infection or history of HCV co-infection;
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Demonstrated absence of HIV infection;
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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:
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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
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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 and 6 to 12 months (to be determined by hepatologist) post treatment.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- AstraZeneca
- Parexel
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D5161N00007
- 2022-001447-24