HÁJEK, Roman, Richard BRYCE, Sunhee RO, Barbara KLENCKE a Heinz LUDWIG. Design and rationale of FOCUS (PX-171-011): A randomized, open-label, phase 3 study of carfilzomib versus best supportive care regimen in patients with relapsed and refractory multiple myeloma (R/R MM). BMC Cancer. England: London : BioMed Central, 2012, roč. 12, Sep 19, s. 415-421. ISSN 1471-2407. doi:10.1186/1471-2407-12-415.
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Základní údaje
Originální název Design and rationale of FOCUS (PX-171-011): A randomized, open-label, phase 3 study of carfilzomib versus best supportive care regimen in patients with relapsed and refractory multiple myeloma (R/R MM)
Autoři HÁJEK, Roman, Richard BRYCE, Sunhee RO, Barbara KLENCKE a Heinz LUDWIG.
Vydání BMC Cancer, England, London : BioMed Central, 2012, 1471-2407.
Další údaje
Originální jazyk angličtina
Typ výsledku Článek v odborném periodiku
Obor 30200 3.2 Clinical medicine
Stát vydavatele Spojené státy
Utajení není předmětem státního či obchodního tajemství
Impakt faktor Impact factor: 3.333
Organizační jednotka Lékařská fakulta
Doi http://dx.doi.org/10.1186/1471-2407-12-415
UT WoS 000311048500001
Klíčová slova anglicky Multiple myeloma; Proteasome inhibitor; Phase 3 trial; Relapsed; Refractory; Overall survival
Příznaky Mezinárodní význam, Recenzováno
Změnil Změnila: Ing. Mgr. Věra Pospíšilíková, učo 9005. Změněno: 23. 4. 2014 15:15.
Anotace
Carfilzomib is a next-generation proteasome inhibitor with single-agent activity in patients with relapsed and refractory multiple myeloma (R/R MM). In PX-171-003-A1, a single-arm phase 2 study of carfilzomib monotherapy in heavily pretreated patients, the overall response rate was 23.7%, 37% of patients achieved >= minimal response and median overall survival (OS) was 15.6 months. Based on this study, carfilzomib was recently approved by the US Food and Drug Administration for the treatment of R/R MM. Herein we describe the trial design and rationale for a phase 3 randomized study, FOCUS (CarFilzOmib for AdvanCed Refractory MUltiple Myeloma European Study), being conducted to compare OS after treatment with single-agent carfilzomib to best supportive care (BSC) regimen in R/R MM. Conclusions: This phase 3 trial will provide more rigorous data for carfilzomib, as this is the first carfilzomib study with OS as the primary endpoint and will not be confounded by crossover and will provide more robust secondary response and safety results that will add to the data set from prior phase 2 studies. FOCUS will facilitate regulatory approvals around the world and expand treatment options for patients with R/R MM.
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