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|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P170019 S017/ PAS001 |
| Date Original Protocol Accepted |
05/06/2022
|
| Date Current Protocol Accepted |
|
| Study Name |
NTRK Clinical Efficacy PAS for Larotrectinib
|
| Device Name |
FoundationOne CDx (F1CDx)
|
| General Study Protocol Parameters |
| Study Design |
Retrospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Infant: 29 days-2 yrs,
Child: 2-12 yrs,
Adolescent: 13-18 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
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.
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| Study Population |
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)
|
| Key Study Endpoints |
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
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