Debio 1347-101 Phase I Trial in Advanced Solid Tumours With Fibroblast Growth Factor Receptor (FGFR) Alterations

Study Name
Debio 1347-101 Phase I Trial in Advanced Solid Tumours With Fibroblast Growth Factor Receptor (FGFR) Alterations
ClinicalTrials.gov Identifier (if applicable)
NCT01948297
Clinical Trial Category (check all that apply)
  • Beyond First Line Therapy
  • Targeted Therapy
Study Center
Institution Name
The University of Texas MD Anderson Cancer Center
Institution Address
1515 Holcombe Blvd
City
Houston
State
Texas
Zip Code
77030
Phone
(713) 745-0746
Website
http://www.mdanderson.org
List additional Institutions (include address, phone number, and website)
Dana-Farber Cancer Institute – Boston, Massachusetts, United States
Massachusetts General Hospital – Boston, Massachusetts, United States
Memorial Sloan-Kettering Hospital – New York, New York, United States
Seoul National University Hospital – Seoul, Republic of Korea
National Cancer Center Singapore – Singapore, Singapore
Vall d’Hebron University Hospital – Barcelona, Spain
Taipei Medical University Hospital – Taipei, Taiwan
Study Contacts
Principal Investigator
Dr. Funda Meric-Bernstam
P.I. Phone
(713) 794-1226
P.I. Email
fmeric@mdanderson.org
Study Coordinator
Holly Oakley
Study Coordinator Phone
(713) 745-0746
Study Coordinator Email
hdoakley@mdanderson.org
OVERVIEW – in layman’s terms (150 words max)
FGFR gene abnormalities have been linked to various cancers. Debio1347 is an inhibitor of FGFR, and therefore is being studied as a therapy for cancer. Debio1347 is a pill that you will take every day. You will see a doctor on a regular basis (weekly at first, then every 2-4 weeks) with labs, EKGs, and ECHOs as indicated.
Enrollment
Actively recruiting
Study Start Date
08/01/2013
Estimated Completion Date
12/31/2018
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
  • To confirm the safety profile of the recommended dose in a larger group of patients.
  • To explore the anti-tumor activity of Debio 1347 in patients with selected cancer types with FGFR1-3 alterations.
Inclusion Criteria – Patients Must:
  • Be 18 years of age or older
  • have an advanced, solid tumor that has recurred or progressed on standard therapy, or for which no standard therapy exists
  • have an FGFR1-3 high expression or fusion alteration
  • be able to swallow pills
  • have adequate organ function as determined by routine blood work
  • have unstained tumor biopsy slides or tumor block available for genetic alteration confirmation
Exclusion Criteria – Patients Must NOT:
  • have certain serious illnesses or medical conditions
  • have a history of current evidence of certain heart conditions
  • be pregnant or lactating
  • be allergic to any of the ingredients in Debio 1347
  • have any other cancers requiring active treatment in the past 6 months
  • have any chronic or uncontrolled infections
  • have uncontrolled diabetes or uncontrolled hypertension
  • have received prior FGF or FGFR1-3 targeted therapy
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms
  • Doctor visit
  • blood and urine samples collected for routine tests
  • tests to check heart function (EKG and ECHO)
  • Chest X-ray (or CT scan) and DEXA scan
  • eye exam
  • biopsy of tumor, if possible
POTENTIAL SIDE-EFFECTS – in layman’s terms
  • high blood levels of phosphate and/or calcium
  • nail changes
  • skin rash/dryness/itching
  • hand-foot syndrome (palms of hands/soles of feet having pain, swelling, and blistering)
  • dry mouth/throat
  • esophageal sores and/or mouth blisters/sores
  • eye problems (such as dryness, blurry vision, redness, irritation, and/or pain)
  • hair loss/thinning
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