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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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Post-Approval Study


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General
Study Status Progress Adequate
Application Number P170019 S017/ PAS001
Date Current Protocol Accepted  
Study Name Post-Approval Study
General Study Protocol Parameters
Study Design Retrospective Cohort Study
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Descriptive
Detailed Study Protocol Parameters
Study Design Description This clinical post-approval study (PAS) is being conducted to confirm the clinical efficacy of F1CDx assay in detecting the NTRK 1/2/3 fusions positive patients for treatment with larotrectinib using solid tumors. This study is intended to fulfill the clinical PAS issued in the approval order for P170019/S017.
The objective of this PAS validation protocol is to determine the clinical efficacy of the variant detection component of the F1CDx assay for rearrangements in the NTRK1, NTRK2, and NTRK3 (NTRK1/2/3) genes as compared to the results obtained for the clinical registrational study samples. Samples from the Bayer-sponsored SCOUT and NAVIGATE clinical trials protocols will be used for this confirmation study. Per FDA approved sample criteria, the standard criteria samples for F1CDx are required to meet the range of greater than or equal to 55 ng to less than or equal to 1000 ng and for the conditional criteria samples for F1CDx are required to meet the range of greater than or equal to 27 ng to <55 ng for DNA yield. Formalin-fixed, paraffin-embedded (FFPE) tissue slide samples meeting either approved or conditional sample criteria will be included in this PAS analysis.
Study Population Description A total of seventeen (17) samples in the form of FFPE slides will be prospectively obtained from NTRK fusion positive patients enrolled in NAVIGATE and SCOUT (cutoff date July 20th, 2021) that were not included in the F1CDx sPMA. All samples with patient informed consent and sufficient tissue meeting either standard or conditional criteria will be retested using the F1CDx assay. Of the 17 total samples, eight (8) samples are expected to meet the standard criteria (greater than or equal to 55 ng to less than or equal to 1000 ng), and nine (9) samples are expected to meet the conditional criteria (greater than or equal to 27 ng to <55 ng).
Sample Size A total of 17 samples (8 Standard and 9 Conditional Criteria)
Data Collection Primary: The Overall Response Rate (ORR) determined by Independent Review Committee (IRC) using RECIST v1.1 will be the primary efficacy end point
Secondary: Duration of Response (DoR), determined with the methods in the drug clinical trials.
Follow-up Visits and Length of Follow-up 2 years for the ORR


Post-Approval Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 04/23/2021 10/15/2021 Overdue/Received
1 year report 04/23/2022 04/22/2022 On Time
18 month report 10/23/2022    


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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