FUZE Clinical Trial

Study Name
FUZE Clinical Trial
ClinicalTrials.gov Identifier (if applicable)
NCT03834220
Clinical Trial Category (check all that apply)
  • Beyond First Line Therapy
  • Targeted Therapy
Study Center
Institution Name
Massachusetts General Hospital
Institution Address
165 Cambridge Street, Suite 302
City
Boston
State
Massachusetts
Zip Code
02114
Country
United States
Phone
(617) 724-4000
Website
https://patients.debiopharm.com/genetic-alterations
List additional Institutions (include address, phone number, and website)
United States, Arizona
University of Arizona Cancer Center
1515 N Campbell Avenue
Tucson, AZ 85724
Phone: +1 (520) 626-7866

United States, California
Moores University of California, San Diego Cancer Center
3855 Health Sciences Drive MC 0698
La Jolla, CA 92093
Phone: +1 (858) 246-1102

University of California, San Francisco
1600 Divisadero, Suite B-718
San Francisco, CA 94115
Phone: +1 (510) 579-5972

United States, Florida
H. Lee Moffitt Cancer Center & Research Institute
1209 Magnolia Drive FOW-EDU
Tampa, FL 33612
Phone: +1 (813) 745-2226

United States, Louisiana
Tulane Cancer Center
1430 Tulane Ave #8078
New Orleans, LA 70122
Phone: +1 (216) 262-1214

United States, Maryland
Johns Hopkins Hospital
1800 Orleans Street
Baltimore, MD 21287
Phone: +1 (410) 955-2130

United States, Massachusetts
Dana-Farber Cancer Institute
450 Brookline Avenue, LG1B12
Boston, MA 02215
Phone:

United States, Michigan
University of Michigan
1150 West Medical Center Drive, 6510 MSRB1
Ann Arbor, MI 48109
Phone: +1 (734) 232-6138

United States, Nebraska
University of Nebraska
668 South 41 Street, 8th Floor
Omaha, NE 68198
Phone: +1 (402) 559-8500

United States, New Jersey
Rutgers Cancer Institute of New Jersey
195 Little Albany Street, Room 5523-02
New Brunswick, NJ 08901
Phone: +1 (732) 235-8991

United States, New York
Memorial Sloan-Kettering, Rockefeller Outpatient Pavilion
160 East 53rd Street
New York, NY 10022
Phone: +1 (646) 888-4544

United States, North Carolina
University of North Carolina at Chapel Hill
101 Manning Drive, Room N3122, 3rd floor Connector link
Chapel Hill, NC 27514
Phone: +1 (919) 843-7714

United States, Ohio
Ohio State University
300 West 10th Avenue, James 0888
Columbus, OH 43210
Phone: +1 (614) 366-1525

UC Health, LLC
3200 Burnet Avenue, 1 Ridgeway #1127
Cincinnati, OH 45229
Phone: +1 (513) 245-3415

United States, Texas
MD Anderson Cancer Center, Department of Investigational Cancer Therapeutics
1515 Holcombe Blvd, Unit 455
Houston, TX 77030
Phone: +1 (713) 794-1226

United States, Washington
Fred Hutchinson, Seattle Cancer Care Alliance
825 Eastlake Ave E
Seattle, WA 98109
Phone: +1 (855) 557-0555

United States, Wisconsin
University of Wisconsin, Madison
600 Highland Ave, Room H6/359
Madison, WI 53792
Phone: +1 (608) 262-7706

*In the Unites States, Debiopharm is working with a partner company capable of rapidly activating clinical trial centers on demand and therefore the list of additional institutions is not exhaustive.

Study Contacts
Principal Investigator
NA
P.I. Phone
(000) 000-0000
P.I. Email
NA@NA.com
Study Coordinator
NA
Study Coordinator Phone
(000) 000-0000
Study Coordinator Email
NA@NA.com
OVERVIEW – in layman’s terms (150 words max)
The FUZE Clinical Trial is evaluating an oral investigational medication, called Debio 1347, that may block cancer cell growth. Debio 1347 targets tumors with a specific genetic alteration, called a fusion, of FGFR 1, 2 or 3 (fibroblast growth factor receptor).
Enrollment
Approximately 125 males and females 18 years of age and older with advanced cancers, like cholangiocarcinoma (excludes blood and brain cancers), with a positive FGFR 1, 2 or 3 gene fusion.
Study Start Date
02/11/2019
Estimated Completion Date
08/31/2020
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
  • The purpose of the FUZE Clinical Trial is to assess whether Debio 1347 is able to target and inhibit a tumor’s altered FGFR molecules and thereby facilitate cancer cell death and shrinkage of the tumor.
Inclusion Criteria – Patients Must:
  • Have advanced cancer with a specific genetic alteration, called a fusion, of FGFR 1, 2 or 3 (brain and blood cancers are excluded).
  • Have cancer that has progressed after treatment
  • Have a tumor that cannot be removed with surgery or has spread (metastasized) to other parts of your body
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1
Exclusion Criteria – Patients Must NOT:
  • Have prior treatment with an FGFR 1, 2 or 3 selective inhibitors
  • Have history of hypersensitivity to any of the ingredients in the Debio 1347 formulation
  • Have history and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia or lung (excludes lymph nodes, lung nodules, asymptomatic vascular or cartilage/tendon)
  • Have had administration of any investigational agent within 2 weeks prior to initial dosing with Debio 1347 (3 weeks for immune checkpoint inhibitors)
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms
  • Fresh sample of tumor tissue or available “biopsy” to confirm FGFR 1, 2 or 3 fusion
  • CT scan or MRI of the involved regions for tumor assessment
  • Physical exam including, but not limited to: height, weight, blood pressure and heart rate
  • Blood draw
  • Urinary pregnancy test, if female of childbearing potential
  • Urinalysis (urine sample)
  • Ophthalmologic (eye) examination
  • Electrocardiogram or “ECG” (electronic heart monitoring)
  • Quality of life assessment
POTENTIAL SIDE-EFFECTS – in layman’s terms
  • Mild dermatologic irritations, such as dry skin, alopecia or rush
  • Mild hyperphosphatemia (elevated levels of phosphate in the body), which may cause minor rash, muscle cramps/spasms, joint pain and/or facial numbness
  • Diarrhea
  • Nausea
  • Fatigue or tiredness
  • Constipation
  • Decreased appetite
  • Changes in nail color and other nail changes
  • Dry mouth or eyes
  • Inflammation of the mouth and lips
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