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
	
								Indianapolis, Indiana 46237			
	
			
					Principal Investigator: Luke Akard
			
						
										Phone: 317-528-7298
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									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  
  
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									1515 Holcombe Boulevard
Houston, Texas 77030
	
			
					Houston, Texas 77030
Principal Investigator: Srdan Verstovsek
			
						
										Phone: 713-563-2622
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									4 Seilerstätte
Linz, 4020
	
			
					Linz, 4020
Principal Investigator: Andreas Petzer
			
						
										Phone: +43 732 7677 4319
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								New York, New York 10021			
	
			
					Principal Investigator: Ellen Ritchie
			
						
										Phone: 212-746-1534
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								Palo Alto, California 94304			
	
			
					Principal Investigator: Jason Gotlib
			
						
										Phone: 650-723-1367
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									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...  
  
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									660 South Euclid Avenue
Saint Louis, Missouri 63110
	
			
					Saint Louis, Missouri 63110
Principal Investigator: Stephen Oh
			
						
										Phone: 314-362-0156
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								Salt Lake City, Utah 84112			
	
			
					Principal Investigator: Michael Deininger
			
						
										Phone: 801-587-9178
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