|
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
|
Clinical Trial Number(s) |
NCT02097810
NCT02568267
NCT02650401
NCT03330990
|
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
|