| 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 