Table 2.
Main clinical trials evaluating NTRK-fusion inhibitors.
| Molecule | Population and Enrollment | Allocation and Intervention Model | Phase | Primary Outcomes | Start Date and Current Status | Identifier |
|---|---|---|---|---|---|---|
|
Entrectinib
(RXDX-101) |
Adult (minimum age: 18 Years)—84 participants | Non-Randomized—Single Group Assignment | I | Dose limiting toxicity Maximum tolerated dose Recommended Phase II dose Overall response rate |
2014—Active, Not Recruiting |
NCT02097810 RXDX-101-01 (STARTRK-1) |
|
Entrectinib
(RXDX-101) |
Adult (minimum age: 18 Years)—300 participants (estimated) | Non-Randomized—Parallel Assignment | II | Objective response rate | 2015—Recruiting |
NCT02568267 RXDX-101-02 (STARTRK-2) |
|
Entrectinib
(RXDX-101) |
Pediatric and Adult (maximum age: 22 Years)—65 participants |
Non-Randomized—Single Group Assignment | I | Maximum tolerated dose Recommended Phase II dose Objective response rate |
2016—Recruiting |
NCT02650401 RXDX-101-03 (STARTRK-NG) |
|
Larotrectinib
(LOXO-101) |
Pediatric and Adult (minimum age: 18 Years)—6452 participants |
Non-Randomized—Parallel Assignment | II | Proportion of patients with objective response | 2015—Recruiting |
NCT02465060 EAY131 NCI-2015-00054 |
|
Larotrectinib
(LOXO-101) |
Pediatric and Adult (minimum age: 12 Years)—320 participants | Non-Randomized—Parallel Assignment | II | Best overall response rate | 2015—Recruiting |
NCT02576431 LOXO-TRK-15002 (NAVIGATE) |
|
Larotrectinib
(LOXO-101) |
Pediatric and Adult (maximum age: 21 Years) —174 participants |
Non-Randomized—Parallel Assignment | I/II | Number and severity of adverse events (Phase I) Overall response rate (Phase II) |
2015—Recruiting |
NCT02637687 LOXO-TRK-15003 (SCOUT) |
|
Larotrectinib
(LOXO-101) |
Pediatric and Adult (from 12 Months to 21 Years)—1000 participants (estimated) |
Non-Randomized—Parallel Assignment | II | Objective response rate | 2017—Recruiting |
NCT03155620 APEC1621SC NCI-2017-01251 |
|
Larotrectinib
(LOXO-101) |
Pediatric and Adult (from 12 Months to 21 Years)—49 participants |
Non-Randomized—Single Group Assignment | II | Objective response rate | 2017—Recruiting |
NCT03213704 APEC1621A NCI-2017-01264 |
|
Larotrectinib
(LOXO-101) |
Pediatric and Adult (maximum age: 30 Years)—70 participants |
Non-Randomized—Single Group Assignment | II | Objective response rate | 2019—Recruiting |
NCT03834961 ADVL1823 NCI-2019-00015 |
|
Repotrectinib
(TPX-0005) |
Pediatric and Adult (12 Years and older)—450 (estimated) | Non-Randomized—Single Group Assignment | I/II | Dose limiting toxicities Recommended Phase II dose Overall response rate |
2019—Recruiting |
NCT03093116 TPX-0005-01 (TRIDENT-1) |
|
Repotrectinib
(TPX-0005) |
Pediatric (4 Years to 12 Years)—12 participants | Non-Randomized—Single Group Assignment | I | Dose limiting toxicities Pediatric recommended Phase II dose |
2019—Recruiting |
NCT04094610 TPX-0005-07 |
|
Selitrectinib
(LOXO-195) |
Pediatric and Adult (minimum age: 1 Month) | Expanded Access (Individual Patients) | NA | NA | 2017—Available (Expanded Access) | NCT03206931 |
|
Selitrectinib
(LOXO-195) |
Pediatric and Adult (minimum age: 1 Month)—93 participants | Non-Randomized—Sequential Assignment | I/II | Maximum tolerated dose Recommended dose Overall response rate |
2017—Recruiting |
NCT03215511 LOXO-EXT-17005 |
NA: Not applicable.