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
Bedford, New Hampshire 03110
Principal Investigator: Konstantin Dragnev
Phone: 603-653-6181
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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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Anderson, Indiana 46011
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Anderson, IN
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Arlington Heights, Illinois 60005
Principal Investigator: Randy Rich
Phone: 847-259-4482
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Arlington Heights, IL
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Baltimore, Maryland 21229
Principal Investigator: Carole Miller
Phone: 410-368-2909
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Bend, Oregon 97701
Principal Investigator: William G. Schmidt
Phone: 541-318-3137
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Bend, OR
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Billings Montana, Montana 59101
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Birmingham, Alabama 35211
Principal Investigator: Ira Gore
Phone: 205-939-7880
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Birmingham, AL
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Cary, North Carolina 27511
Principal Investigator: Suzanne Kirby
Phone: +1 919 233 8585 ext. 111
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Chapel Hill, NC
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Chattanooga, TN
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Chicago, Illinois 60611
Principal Investigator: Young Chae
Phone: 312-695-0184
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Chicago, IL
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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
Principal Investigator: Herbert Hurwitz
Phone: 919-681-6006
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Durham, NC
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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
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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: Jenny Chang
Phone: 713-441-0681
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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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Indianapolis, IN
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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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McAllen, Texas 78503
Principal Investigator: Alvaro Restrepo
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Miami, FL
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Minneapolis, MN
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Murray, Utah 84157
Principal Investigator: Lincoln Nadauld
Phone: 435-688-4900
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Murray, UT
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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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Norwalk, Connecticut 06856
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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, PA
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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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San Francisco, CA
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900 East 54th Street North
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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South Bend, IN
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Tacoma, Washington 98405
Principal Investigator: Sibel Blau
Phone: 253-841-4296
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1700 West Highway 6
Waco, Texas 76712
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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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Winston-Salem, North Carolina 27157
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