A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203)
Status: | Recruiting |
---|---|
Conditions: | Lymphoma, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/12/2018 |
Start Date: | December 26, 2016 |
End Date: | December 2019 |
Contact: | Incyte Corporation Call Center |
Phone: | 1.855.463.3463 |
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)
The purpose of this study is to evaluate the efficacy and safety of pemigatinib (INCB054828)
in subjects with myeloid/lymphoid neoplasms with fibroblast growth factor receptor (FGFR) 1
rearrangement.
in subjects with myeloid/lymphoid neoplasms with fibroblast growth factor receptor (FGFR) 1
rearrangement.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
We found this trial at
10
sites
4 Seilerstätte
Linz, 4020
Linz, 4020
Principal Investigator: Andreas Petzer
Phone: +43 732 7677 4319
Click here to add this to my saved trials
1365 Clifton Rd NE
Atlanta, Georgia 30322
Atlanta, Georgia 30322
(404) 778-1900
Principal Investigator: Elliott Winton
Phone: 404-778-4334
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
Click here to add this to my saved trials
Click here to add this to my saved trials
1515 Holcombe Boulevard
Houston, Texas 77030
Houston, Texas 77030
Principal Investigator: Srdan Verstovsek
Phone: 713-563-2622
Click here to add this to my saved trials
Indianapolis, Indiana 46237
Principal Investigator: Luke Akard
Phone: 317-528-7298
Click here to add this to my saved trials
New York, New York 10021
Principal Investigator: Ellen Ritchie
Phone: 212-746-1534
Click here to add this to my saved trials
Palo Alto, California 94304
Principal Investigator: Jason Gotlib
Phone: 650-723-1367
Click here to add this to my saved trials
5777 East Mayo Boulevard
Phoenix, Arizona 85054
Phoenix, Arizona 85054
(480) 515-6296
Principal Investigator: Jeanne Palmer
Phone: 480-342-6034
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
Click here to add this to my saved trials
660 South Euclid Avenue
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
Principal Investigator: Stephen Oh
Phone: 314-362-0156
Click here to add this to my saved trials
Salt Lake City, Utah 84112
Principal Investigator: Michael Deininger
Phone: 801-587-9178
Click here to add this to my saved trials