Difference between revisions of "Malignant solid neoplasm, NTRK-mutated"
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''Note: this is the MTD used in the phase 2 portion; it is also the FDA-recommended dose for adults.'' | ''Note: this is the MTD used in the phase 2 portion; it is also the FDA-recommended dose for adults.'' | ||
| − | ==== | + | ====Targeted therapy==== |
*[[Entrectinib (Rozlytrek)]] 600 mg PO once per day | *[[Entrectinib (Rozlytrek)]] 600 mg PO once per day | ||
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''Note: these three trials are all reported in a single publication; the doses here are the FDA-recommended doses.'' | ''Note: these three trials are all reported in a single publication; the doses here are the FDA-recommended doses.'' | ||
| − | ==== | + | ====Targeted therapy==== |
*[[Larotrectinib (Vitrakvi)]] as follows: | *[[Larotrectinib (Vitrakvi)]] as follows: | ||
**Adults: 100 mg PO twice per day | **Adults: 100 mg PO twice per day | ||
Revision as of 00:04, 27 August 2020
2 regimens on this page
3 variants on this page
|
All lines of therapy
Entrectinib monotherapy
| back to top |
Regimen
| FDA-recommended dose |
| Study | Years of enrollment | Evidence |
|---|---|---|
| Drilon et al. 2017 (ALKA-372-001) | 2012-2016 | Phase I |
| Drilon et al. 2017 (STARTRK-1) | 2012-2016 | Phase I (RT) |
Note: this is the MTD used in the phase 2 portion; it is also the FDA-recommended dose for adults.
Targeted therapy
- Entrectinib (Rozlytrek) 600 mg PO once per day
Continued indefinitely
References
- Phase 1: Drilon A, Siena S, Ou SI, Patel M, Ahn MJ, Lee J, Bauer TM, Farago AF, Wheler JJ, Liu SV, Doebele R, Giannetta L, Cerea G, Marrapese G, Schirru M, Amatu A, Bencardino K, Palmeri L, Sartore-Bianchi A, Vanzulli A, Cresta S, Damian S, Duca M, Ardini E, Li G, Christiansen J, Kowalski K, Johnson AD, Patel R, Luo D, Chow-Maneval E, Hornby Z, Multani PS, Shaw AT, De Braud FG. Safety and antitumor activity of the multitargeted pan-TRK, ROS1, and ALK inhibitor entrectinib: combined results from two phase I trials (ALKA-372-001 and STARTRK-1). Cancer Discov. 2017 Apr;7(4):400-409. Epub 2017 Feb 9. link to original article link to PMC article PubMed
Larotrectinib monotherapy
| back to top |
Regimen
| FDA-recommended dose |
| Study | Years of enrollment | Evidence |
|---|---|---|
| Drilon et al. 2018 (LOXO-TRK-14001) | 2015-2017 | Phase 1 (RT) |
| Drilon et al. 2018 (SCOUT) | 2015-2017 | Phase I/II (RT) |
| Drilon et al. 2018 (NAVIGATE) | 2015-2017 | Phase II (RT) |
Note: these three trials are all reported in a single publication; the doses here are the FDA-recommended doses.
Targeted therapy
- Larotrectinib (Vitrakvi) as follows:
- Adults: 100 mg PO twice per day
- Pediatrics: 100 mg/m2 (maximum dose of 100 mg) PO twice per day
Continued indefinitely
References
- SCOUT; NAVIGATE: Drilon A, Laetsch TW, Kummar S, DuBois SG, Lassen UN, Demetri GD, Nathenson M, Doebele RC, Farago AF, Pappo AS, Turpin B, Dowlati A, Brose MS, Mascarenhas L, Federman N, Berlin J, El-Deiry WS, Baik C, Deeken J, Boni V, Nagasubramanian R, Taylor M, Rudzinski ER, Meric-Bernstam F, Sohal DPS, Ma PC, Raez LE, Hechtman JF, Benayed R, Ladanyi M, Tuch BB, Ebata K, Cruickshank S, Ku NC, Cox MC, Hawkins DS, Hong DS, Hyman DM. Efficacy of larotrectinib in TRK fusion-positive cancers in adults and children. N Engl J Med. 2018 Feb 22;378(8):731-739. link to original article contains protocol link to PMC article PubMed