BGJ398 for Patients With Tumors With FGFR Genetic Alterations
| Status: | Completed | 
|---|---|
| Conditions: | Cancer, Blood Cancer | 
| Therapuetic Areas: | Oncology | 
| Healthy: | No | 
| Age Range: | 18 - Any | 
| Updated: | 10/26/2018 | 
| Start Date: | July 24, 2014 | 
| End Date: | April 30, 2018 | 
Modular Phase II Study to Link Targeted Therapy to Patients With Pathway Activated Tumors: Module 6 - BGJ398 for Patients With Tumors With FGFR Genetic Alterations
The purpose of this signal seeking study is to determine whether treatment with BGJ398
demonstrates sufficient efficacy in select FGFR pathway-regulated solid tumors and/or
hematologic malignancies to warrant further study.
			demonstrates sufficient efficacy in select FGFR pathway-regulated solid tumors and/or
hematologic malignancies to warrant further study.
Inclusion Criteria:
Patient has a confirmed diagnosis of a select solid tumor (except with a primary diagnosis
of Urothelial cell carcinoma, Cholangiocarcinoma, Endometrial cancer, and Glioblastoma
multiforme) or hematologic malignancies and is in need of treatment because of progression
or relapse.
Patient's tumor has been evaluated and pre-identified as having a tumor with a FGFR genetic
alteration. The qualifying alteration must be assessed and reported by a CLIA-certified
laboratory.
Patient must have received at least one prior treatment for recurrent, metastatic and /or
locally advanced disease and for whom no standard therapy options are anticipated to result
in a durable remission.
Patient must have progressive and measurable disease per RECIST 1.1. or other appropriate
hematological response criteria.
Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
Exclusion Criteria:
Patient has received prior treatment with BGJ398
Patients with Central Nervous System (CNS) metastasis or leptomeningeal carcinomatosis
Patient has received chemotherapy or other anticancer therapy ≤ 4 weeks (6 weeks for
nitrosourea, antibodies or mitomycin-C) prior to starting study drug.
Patients with acute or chronic pancreatitis
Patients with impaired cardiac function or clinically significant cardiac diseases
History and/or current evidence of extensive tissue calcification
Use of medications that increase serum levels of phosphorus and/or calcium
Current evidence of corneal or retinal disorder/keratopathy
History and/or current evidence of renal or endocrine alterations of calcium/phosphate
homeostasis
Patients with another primary malignancy within 3 years prior to starting study treatment,
with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or
other non-melanomatous skin cancer, or in-situ carcinoma of the uterine cervix
We found this trial at
    56
    sites
	
								Houston, Texas 77030			
	
			
					Principal Investigator: Jenny Chang
			
						
										Phone: 713-441-0681
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								Albuquerque, New Mexico 87109			
	
			
					Principal Investigator: Govardhanan Nagaiah
			
						
										Phone: 505-243-4039
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								Allentown, Pennsylvania 18105			
	
			
					Principal Investigator: Usman Shah
			
						
										Phone: 610-402-9543
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								Arlington Heights, Illinois 60005			
	
			
					Principal Investigator: Randy Rich
			
						
										Phone: 847-259-4482
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								Baltimore, Maryland 21229			
	
			
					Principal Investigator: Carole Miller
			
						
										Phone: 410-368-2909
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								Bedford, New Hampshire 03110			
	
			
					Principal Investigator: Konstantin Dragnev
			
						
										Phone: 603-653-6181
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								Bend, Oregon 97701			
	
			
					Principal Investigator: William G. Schmidt
			
						
										Phone: 541-318-3137
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								Birmingham, Alabama 35211			
	
			
					Principal Investigator: Ira Gore
			
						
										Phone: 205-939-7880
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								Cary, North Carolina 27511			
	
			
					Principal Investigator: Suzanne Kirby
			
						
										Phone: +1 919 233 8585 ext. 111
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								Chattanooga, Tennessee 37404			
	
			
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								Chicago, Illinois 60611			
	
			
					Principal Investigator: Young Chae
			
						
										Phone: 312-695-0184
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								Cincinnati, Ohio 45242			
	
			
					Principal Investigator: Patrick Ward
			
						
										Phone: 513-751-2273
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								Cleveland, Ohio 44106			
	
			
					Principal Investigator: Christopher Hoimes
			
						
										Phone: 216-844-5176
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								Cleveland, Ohio 44195			
	
			
					Principal Investigator: Davendra Sohal
			
						
										Phone: 216-444-8258
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									103 Seeley Mudd Building
Durham, North Carolina 27710
	
			
					Durham, North Carolina 27710
Principal Investigator: Herbert Hurwitz
			
						
										Phone: 919-681-6006
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								Fairfax, Virginia 22031			
	
			
					Principal Investigator: Alexander Spira
			
						
										Phone: 703-208-3148
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								Fairhaven, Massachusetts 02719			
	
			
					Principal Investigator: Elizabeth Blanchard
			
						
										Phone: 508-973-3000
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								Fargo, North Dakota 58122			
	
			
					Principal Investigator: Anu Goel Gaba
			
						
										Phone: 701-234-2371
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									4371 Veronica S Shoemaker Boulevard
Fort Myers, Florida 33901
	
			
					Fort Myers, Florida 33901
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								Fort Worth, Texas 76104			
	
			
					Principal Investigator: Ray D. Page
			
						
										Phone: 817-759-7000
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								Grand Rapids, Michigan 49546			
	
			
					Principal Investigator: Nehal Lakhani
			
						
										Phone: 616-954-5550
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								Greenwood Village, Colorado 80304			
	
			
					Principal Investigator: Leslie T. Busby
			
						
										Phone: 714-835-1800
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								Houston, Texas 77024			
	
			
					Principal Investigator: Julio Peguero
			
						
										Phone: 832-824-5383
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								Houston, Texas 77030			
	
			
					Principal Investigator: Sarina Piha-Paul
			
						
										Phone: 216-255-2748
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								Indianapolis, Indiana 46202			
	
			
					Principal Investigator: Bert O'Neil
			
						
										Phone: 317-278-8845
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								Kansas City, Missouri 64132			
	
			
					Principal Investigator: Jaswinder Singh
			
						
										Phone: 816-276-4227
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								Louisville, Kentucky 40202			
	
			
					Principal Investigator: Dharamvir Jain
			
						
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								Marietta, Georgia 30060			
	
			
					Principal Investigator: Robert C. Hermann
			
						
										Phone: 770-281-5131
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								Murray, Utah 84157			
	
			
					Principal Investigator: Lincoln Nadauld
			
						
										Phone: 435-688-4900
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								Nashville, Tennessee 37203			
	
			
					Principal Investigator: Todd M. Bauer
			
						
										Phone: 615-329-7664
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								New Brunswick, New Jersey 08903			
	
			
					Principal Investigator: Janice Mehnert
			
						
										Phone: 732-235-6031
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								Oceanside, California 92056			
	
			
					Principal Investigator: Nayyar Siddique
			
						
										Phone: 760-758-5770
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								Ogden, Utah 84403			
	
			
					Principal Investigator: Vincent Hansen
			
						
										Phone: 801-387-7150
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								Philadelphia, Pennsylvania 19124			
	
			
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								Pittsburgh, Pennsylvania 15232			
	
			
					Principal Investigator: Hussein Tawbi
			
						
										Phone: 412-647-8205
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								Portland, Oregon 97210			
	
			
					Principal Investigator: David A. Smith
			
						
										Phone: 360-449-6522
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								Providence, Rhode Island 02903			
	
			
					Principal Investigator: Howard Safran
			
						
										Phone: 401-444-3059
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								Rome, Georgia 30165			
	
			
					Principal Investigator: Dilawar Khan
			
						
										Phone: 706-528-9094
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								Salt Lake City, Utah 84103			
	
			
					Principal Investigator: Sunil Sharma
			
						
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								Salt Lake City, Utah 84106			
	
			
					Principal Investigator: Stephan D. Kendall
			
						
										Phone: 801-281-6864
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								San Antonio, Texas 78229			
	
			
					Principal Investigator: Woondong Jeong
			
						
										Phone: 210-450-5956
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									900 East 54th Street North
Sioux Falls, South Dakota 57104
	
			
					Sioux Falls, South Dakota 57104
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								South Bend, Indiana 46617			
	
			
					Principal Investigator: Jose A. Bufill
			
						
										Phone: 574-237-1328
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								Tacoma, Washington 98405			
	
			
					Principal Investigator: Sibel Blau
			
						
										Phone: 253-841-4296
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								Webster, Texas 77598			
	
			
					Principal Investigator: Dhatri Kodali
			
						
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								Winchester, Virginia 22601			
	
			
					Principal Investigator: William Houck III
			
						
										Phone: 540-662-1108
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