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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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ROZYLTREK PAS


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General
Study Status Ongoing
Application Number /
Requirement Number		 P170019 S014/ PAS001
Date Original Protocol Accepted 05/26/2023
Date Current Protocol Accepted  
Study Name ROZYLTREK PAS
Device Name FoundationOne CDx
General Study Protocol Parameters
Study Design Retrospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Child: 2-12 yrs, Adolescent: 13-18 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives This clinical post-approval study (PAS) is being conducted to confirm the clinical effectiveness of the F1CDx assay in detecting NTRK1/2/3 fusion positive patients with solid tumors for treatment with entrectinib. This study is intended to fulfil the clinical PAS issued in the approval order for P170019/S014. This PAS will supplement the premarket clinical bridging study with additional patients from the STARTRK-2 trial (non-NDA population) who have a later enrollment date as well as patients enrolled in the TAPISTRY trial (NCT04589845).
The first objective of this clinical bridging study is to evaluate the concordance of F1CDx and LDT results in the identification of NTRK1/2/3 fusions. Samples from various tumor types will be included.
The second objective of this study is to evaluate the overall response rate (ORR) and duration of response (DOR) for entrectinib treatment among clinical study subjects who solid tumor specimens are NTRK1/2/3 fusion positive, per the CDx biomarker definition, by retrospective testing with F1CDx, per the CDx biomarker definition.
Study Population The study consists of approximately 101 NTRK1/2/3 fusion positive patients from the STARTRK-2 trial enrolled after April 2018 and by Q2 2022, and approximately 15 patients from Cohort B of the TAPISTRY trial enrolled by Q2 2022. Of these, an estimated 67 samples will have sufficient residual DNA (or total nuclei acid (TNA)) and patient consent for F1CDx testing.
Approximately 250 NTRK1/2/3 fusion negative specimens of various disease ontologies from the FMI archive will be included in the agreement analysis.
Sample Size Approximately 116 NTRK1/2/3 fusion positive patients and approximately 250 NTRK1/2/3 fusion negative specimens (for concordance analysis only)
Key Study Endpoints Primary Effectiveness Endpoint: Concordance of F1CDx and LDT results in the identification of NTRK1/2/3 fusions
Secondary Effectiveness Endpoints: ORR and DOR of entrectinib
Follow-up Visits and Length of Follow-up 1 year for the ORR


ROZYLTREK PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 12/07/2022 12/06/2022 On Time
1 year report 06/07/2023 06/08/2023 Overdue/Received
18 month report 12/07/2023 12/06/2023 On Time
2 year report 06/07/2024    


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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