ROSY-T: Roll Over StudY for Patients Who Have Completed a Previous Oncology Study with Osimertinib (TAGRISSO) and are Judged by the Investigator to Clinically Benefit From Continued Treatment

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Astrazeneca AB

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

16 Oct 2023 → ongoing

Decision date (initial)

2023-08-09

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety

To provide continuous study treatment to patients who continue to benefit at the end of a clinical trial, while monitoring safety and tolerability of osimertinib (TAGRISSO)

Conditions and MedDRA coding

Various tumor types depending on the parent study

Study design 2 periods

Regulatory references

Plan to share IPD

Yes

IPD 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 Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared. AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment https://vivli.org/. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Provision of signed and dated, written ICF.
2. Patient is currently deriving clinical benefit, as judged by the Investigator, from continued treatment with osimertinib (TAGRISSO) in an AstraZeneca parent study using osimertinib (TAGRISSO) monotherapy, which has met its endpoints or has otherwise stopped.
3. Females should be using adequate contraceptive measures if of childbearing potential. Male patients should be willing to use barrier contraception, ie, condoms.

Exclusion criteria 6

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. Note: In countries where, according to local requirements, it is not possible to switch patients to the commercial drug through prescription, even if fully reimbursed, patients are eligible to participate in the ROSY-T sub-study.
6. Active infection (eg, patients receiving treatment for infection) including active hepatitis C and HIV infection or active uncontrolled 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 and 6 to 12 months (to be determined by hepatologist) post treatment.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. SAEs and serious AESIs reported until 28 days after the last dose of study treatment

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Astrazeneca AB

Sponsor organisation

Astrazeneca AB

Address

Astraallen Gartuna, Karlebyhus Byggnad 674 Karlebyhus Byggnad 674

City

Sodertalje

Postcode

151 85

Country

Sweden

Scientific contact point

Organisation

Astrazeneca AB

Contact name

Clinical Trial Information Center

Public contact point

Organisation

Astrazeneca AB

Contact name

Clinical Trial Information Center

Third parties 1

Locations

2 EU/EEA countries · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 15 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications