Difference between revisions of "Tenosynovial giant cell tumor"
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| style="background-color:#1a9851" |Phase 3 (E-RT-esc) | | style="background-color:#1a9851" |Phase 3 (E-RT-esc) | ||
| − | |[[# | + | |[[#Placebo_888|Placebo]]<sup>1</sup> |
| style="background-color:#1a9850" |Superior ORR | | style="background-color:#1a9850" |Superior ORR | ||
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Revision as of 00:47, 18 June 2023
Section editor transclusions Note: these are regimens tested in subtype-specific populations, please see the main soft tissue sarcoma page for other regimens.
1 regimens on this page
1 variants on this page
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All lines of therapy
Pexidartinib monotherapy
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Tap et al. 2019 (ENLIVEN) | 2015-2016 | Phase 3 (E-RT-esc) | Placebo1 | Superior ORR |
1Patents assigned to placebo were offered open-label pexidartinib after week 24.
Targeted therapy
- Pexidartinib (Turalio) as follows:
- Cycle 1: 400 mg PO every morning and 600 mg PO every evening
- Cycle 2 onwards: 400 mg PO twice per day
14-day cycles
References
- ENLIVEN: Tap WD, Gelderblom H, Palmerini E, Desai J, Bauer S, Blay JY, Alcindor T, Ganjoo K, Martín-Broto J, Ryan CW, Thomas DM, Peterfy C, Healey JH, van de Sande M, Gelhorn HL, Shuster DE, Wang Q, Yver A, Hsu HH, Lin PS, Tong-Starksen S, Stacchiotti S, Wagner AJ; ENLIVEN investigators. Pexidartinib versus placebo for advanced tenosynovial giant cell tumour (ENLIVEN): a randomised phase 3 trial. Lancet. 2019 Aug 10;394(10197):478-487. Epub 2019 Jun 19. link to original article link to PMC article contains dosing details in manuscript PubMed Clinical Trials Registry