Deutsches Leukämie-Studienregister
Studie: INCB 54828-203

Kurzübersicht
Öffentlicher Titel Phase-II-Studie zu Pemigatinib bei Patienten mit myeloischen/lymphatischen Neoplasien mit FGFR-Umlagerung
Wissenschaftl. Titel A Phase 2, Open-Label, Monotherapy, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203)
Kurztitel INCB 54828-203
Studiennummer KN/ELN LN_NN_2018_636
Studiengruppe NN
Studienart multizentrisch, prospektiv, offen
Studienphase Phase II
Erkrankung Myeloproliferative Neoplasien (MPN) - Alle Subtypen
Leukämiestadium .
Einschlusskriterien
  • Documented lymphoid or myeloid neoplasm with 8p11 rearrangement known to lead to FGFR1 activation, based on standard diagnostic cytogenetic evaluation performed locally, before signing informed consent for this study.
  • Subjects must be relapsed/refractory. Prior stem cell transplantation is allowed.
  • Life expectancy ≥ 12 weeks.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
Ausschlusskriterien
  • Prior receipt of a selective FGFR inhibitor.
  • History and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, except calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcifications.
  • Current evidence of corneal disorder/keratopathy, including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, and keratoconjunctivitis, as confirmed by ophthalmologic examination.
  • Use of any potent cytochrome P450 3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug.
Alter >= 18 Jahre
Status Aktiv
Beginn der Rekrutierung 10.10.2018
Kurzprotokoll Kurzprotokoll
Sponsoren Incyte Corporation
Registrierung in anderen Studienregistern ClinicalTrials.gov NCT03011372
erstellt 16.01.2019 Zenawit Krüger
geändert 16.01.2019 Zenawit Krüger
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