Difference between revisions of "Tenosynovial giant cell tumor - null regimens"
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| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
|[[Tenosynovial_giant_cell_tumor#Pexidartinib_monotherapy|Pexidartinib]] | |[[Tenosynovial_giant_cell_tumor#Pexidartinib_monotherapy|Pexidartinib]] | ||
| + | | style="background-color:#d73027" |Inferior ORR (primary endpoint) | ||
| + | |- | ||
| + | |[https://doi.org/10.1016/s0140-6736(24)00885-7 Gelderblom et al. 2024 (MOTION)] | ||
| + | |2022-01-21 to 2023-02-21 | ||
| + | | style="background-color:#1a9851" |Phase 3 (C) | ||
| + | |[[Tenosynovial_giant_cell_tumor#Vimseltinib_monotherapy_777|Vimseltinib]] | ||
| style="background-color:#d73027" |Inferior ORR (primary endpoint) | | style="background-color:#d73027" |Inferior ORR (primary endpoint) | ||
|- | |- | ||
| Line 29: | Line 35: | ||
===References=== | ===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. [https://doi.org/10.1016/s0140-6736(19)30764-0 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6860022/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/31229240/ PubMed] [https://clinicaltrials.gov/study/NCT02371369 NCT02371369] | # '''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. [https://doi.org/10.1016/s0140-6736(19)30764-0 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6860022/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/31229240/ PubMed] [https://clinicaltrials.gov/study/NCT02371369 NCT02371369] | ||
| + | #'''MOTION:''' Gelderblom H, Bhadri V, Stacchiotti S, Bauer S, Wagner AJ, van de Sande M, Bernthal NM, López Pousa A, Razak AA, Italiano A, Ahmed M, Le Cesne A, Tinoco G, Boye K, Martín-Broto J, Palmerini E, Tafuto S, Pratap S, Powers BC, Reichardt P, Casado Herráez A, Rutkowski P, Tait C, Zarins F, Harrow B, Sharma MG, Ruiz-Soto R, Sherman ML, Blay JY, Tap WD; MOTION investigators. Vimseltinib versus placebo for tenosynovial giant cell tumour (MOTION): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2024 Jun 22;403(10445):2709-2719. Epub 2024 Jun 3. [https://doi.org/10.1016/s0140-6736(24)00885-7 link to original article] [https://pubmed.ncbi.nlm.nih.gov/38843860/ PubMed] [https://clinicaltrials.gov/study/NCT05059262 NCT05059262] | ||
| + | |||
[[Category:Tenosynovial giant cell tumor regimens]] | [[Category:Tenosynovial giant cell tumor regimens]] | ||
[[Category:Disease-specific pages]] | [[Category:Disease-specific pages]] | ||
[[Category:Soft tissue sarcomas]] | [[Category:Soft tissue sarcomas]] | ||
[[Category:Null regimens]] | [[Category:Null regimens]] | ||
Latest revision as of 00:29, 4 July 2024
The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main TGCT page for regimens that include active anticancer treatment.
All lines of therapy
Placebo
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Tap et al. 2019 (ENLIVEN) | 2015-05 to 2016-09 | Phase 3 (C) | Pexidartinib | Inferior ORR (primary endpoint) |
| Gelderblom et al. 2024 (MOTION) | 2022-01-21 to 2023-02-21 | Phase 3 (C) | Vimseltinib | Inferior ORR (primary endpoint) |
No active antineoplastic treatment.
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 PubMed NCT02371369
- MOTION: Gelderblom H, Bhadri V, Stacchiotti S, Bauer S, Wagner AJ, van de Sande M, Bernthal NM, López Pousa A, Razak AA, Italiano A, Ahmed M, Le Cesne A, Tinoco G, Boye K, Martín-Broto J, Palmerini E, Tafuto S, Pratap S, Powers BC, Reichardt P, Casado Herráez A, Rutkowski P, Tait C, Zarins F, Harrow B, Sharma MG, Ruiz-Soto R, Sherman ML, Blay JY, Tap WD; MOTION investigators. Vimseltinib versus placebo for tenosynovial giant cell tumour (MOTION): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2024 Jun 22;403(10445):2709-2719. Epub 2024 Jun 3. link to original article PubMed NCT05059262