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

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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.


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
Fort Worth, Texas 76104
Principal Investigator: Ray D. Page
Phone: 817-759-7000
937
mi
from 43215
Fort Worth, TX
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Albuquerque, New Mexico 87109
Principal Investigator: Govardhanan Nagaiah
Phone: 505-243-4039
1327
mi
from 43215
Albuquerque, NM
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Allentown, Pennsylvania 18105
Principal Investigator: Usman Shah
Phone: 610-402-9543
400
mi
from 43215
Allentown, PA
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Anderson, Indiana 46011
140
mi
from 43215
Anderson, IN
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Arlington Heights, Illinois 60005
Principal Investigator: Randy Rich
Phone: 847-259-4482
299
mi
from 43215
Arlington Heights, IL
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Baltimore, Maryland 21229
Principal Investigator: Carole Miller
Phone: 410-368-2909
340
mi
from 43215
Baltimore, MD
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Bedford, New Hampshire 03110
Principal Investigator: Konstantin Dragnev
Phone: 603-653-6181
629
mi
from 43215
Bedford, NH
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Bend, Oregon 97701
Principal Investigator: William G. Schmidt
Phone: 541-318-3137
1967
mi
from 43215
Bend, OR
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Billings Montana, Montana 59101
?
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from 43215
Billings Montana, MT
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Birmingham, Alabama 35211
Principal Investigator: Ira Gore
Phone: 205-939-7880
497
mi
from 43215
Birmingham, AL
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Cary, North Carolina 27511
Principal Investigator: Suzanne Kirby
Phone: +1 919 233 8585 ext. 111
371
mi
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Cary, NC
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353
mi
from 43215
Chapel Hill, NC
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362
mi
from 43215
Chattanooga, TN
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Chicago, Illinois 60611
Principal Investigator: Young Chae
Phone: 312-695-0184
274
mi
from 43215
Chicago, IL
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Cincinnati, Ohio 45242
Principal Investigator: Patrick Ward
Phone: 513-751-2273
87
mi
from 43215
Cincinnati, OH
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Cleveland, Ohio 44106
Principal Investigator: Christopher Hoimes
Phone: 216-844-5176
129
mi
from 43215
Cleveland, OH
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Cleveland, Ohio 44195
Principal Investigator: Davendra Sohal
Phone: 216-444-8258
129
mi
from 43215
Cleveland, OH
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103 Seeley Mudd Building
Durham, North Carolina 27710
Principal Investigator: Herbert Hurwitz
Phone: 919-681-6006
352
mi
from 43215
Durham, NC
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Fairfax, Virginia 22031
Principal Investigator: Alexander Spira
Phone: 703-208-3148
314
mi
from 43215
Fairfax, VA
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Fairhaven, Massachusetts 02719
Principal Investigator: Elizabeth Blanchard
Phone: 508-973-3000
643
mi
from 43215
Fairhaven, MA
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Fargo, North Dakota 58122
Principal Investigator: Anu Goel Gaba
Phone: 701-234-2371
837
mi
from 43215
Fargo, ND
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4371 Veronica S Shoemaker Boulevard
Fort Myers, Florida 33901
925
mi
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Fort Myers, FL
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Grand Rapids, Michigan 49546
Principal Investigator: Nehal Lakhani
Phone: 616-954-5550
241
mi
from 43215
Grand Rapids, MI
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Greenwood Village, Colorado 80304
Principal Investigator: Leslie T. Busby
Phone: 714-835-1800
1161
mi
from 43215
Greenwood Village, CO
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Houston, Texas 77024
Principal Investigator: Julio Peguero
Phone: 832-824-5383
996
mi
from 43215
Houston, TX
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Houston, Texas 77030
Principal Investigator: Jenny Chang
Phone: 713-441-0681
995
mi
from 43215
Houston, TX
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Houston, Texas 77030
Principal Investigator: Sarina Piha-Paul
Phone: 216-255-2748
995
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Houston, TX
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Indianapolis, Indiana 46202
Principal Investigator: Bert O'Neil
Phone: 317-278-8845
167
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from 43215
Indianapolis, IN
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Kansas City, Missouri 64132
Principal Investigator: Jaswinder Singh
Phone: 816-276-4227
618
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Kansas City, MO
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Louisville, Kentucky 40202
Principal Investigator: Dharamvir Jain
188
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Louisville, KY
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Marietta, Georgia 30060
Principal Investigator: Robert C. Hermann
Phone: 770-281-5131
423
mi
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Marietta, GA
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McAllen, Texas 78503
Principal Investigator: Alvaro Restrepo
1294
mi
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McAllen, TX
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992
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Miami, FL
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625
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Minneapolis, MN
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Murray, Utah 84157
Principal Investigator: Lincoln Nadauld
Phone: 435-688-4900
1514
mi
from 43215
Murray, UT
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Nashville, Tennessee 37203
Principal Investigator: Todd M. Bauer
Phone: 615-329-7664
333
mi
from 43215
Nashville, TN
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New Brunswick, New Jersey 08903
Principal Investigator: Janice Mehnert
Phone: 732-235-6031
453
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from 43215
New Brunswick, NJ
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Norwalk, Connecticut 06856
510
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Norwalk, CT
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Oceanside, California 92056
Principal Investigator: Nayyar Siddique
Phone: 760-758-5770
1945
mi
from 43215
Oceanside, CA
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Ogden, Utah 84403
Principal Investigator: Vincent Hansen
Phone: 801-387-7150
1514
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Ogden, UT
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416
mi
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Philadelphia, PA
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Pittsburgh, Pennsylvania 15232
Principal Investigator: Hussein Tawbi
Phone: 412-647-8205
166
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Pittsburgh, PA
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Portland, Oregon 97210
Principal Investigator: David A. Smith
Phone: 360-449-6522
2029
mi
from 43215
Portland, OR
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Providence, Rhode Island 02903
Principal Investigator: Howard Safran
Phone: 401-444-3059
619
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Providence, RI
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Rome, Georgia 30165
Principal Investigator: Dilawar Khan
Phone: 706-528-9094
411
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Rome, GA
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Salt Lake City, Utah 84103
Principal Investigator: Sunil Sharma
1510
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Salt Lake City, UT
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Salt Lake City, Utah 84106
Principal Investigator: Stephan D. Kendall
Phone: 801-281-6864
1512
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Salt Lake City, UT
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San Antonio, Texas 78229
Principal Investigator: Woondong Jeong
Phone: 210-450-5956
1138
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San Antonio, TX
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2106
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San Francisco, CA
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900 East 54th Street North
Sioux Falls, South Dakota 57104
747
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Sioux Falls, SD
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South Bend, Indiana 46617
Principal Investigator: Jose A. Bufill
Phone: 574-237-1328
205
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South Bend, IN
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Tacoma, Washington 98405
Principal Investigator: Sibel Blau
Phone: 253-841-4296
2013
mi
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Tacoma, WA
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1700 West Highway 6
Waco, Texas 76712
984
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Waco, TX
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Webster, Texas 77598
Principal Investigator: Dhatri Kodali
993
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Webster, TX
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Winchester, Virginia 22601
Principal Investigator: William Houck III
Phone: 540-662-1108
264
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Winchester, VA
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Winston-Salem, North Carolina 27157
306
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Winston-Salem, NC
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