A Dose Finding Study Followed by a Safety and Efficacy Study in Patients With Advanced Solid Tumors With FGF/FGFR-Related Abnormalities

Study Name
A Dose Finding Study Followed by a Safety and Efficacy Study in Patients With Advanced Solid Tumors With FGF/FGFR-Related Abnormalities
ClinicalTrials.gov Identifier (if applicable)
NCT02052778
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
Website
https://www.mdanderson.org/
List additional Institutions (include address, phone number, and website)
USA: Massachusetts General Hospital
USA: Greenville Health System ITOR
Australia: Royal Melbourne Hospital
France: Institut Bergonie
France: Centre Léon Bérard Bât
France: Pitié-Salpêtrière Hospital
France: Institute Goustave-Roussy
Spain: Vall D’Hebron University Hospital
Spain: University Hospital Ramón y Cajal
Spain: Centro Integral Oncológico Clara Campal – Hospital Universitario Madrid Sanchinarro
UK: Sarah Cannon Research Institute
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. TAS-120 is an inhibitor of FGFR and therefore is being studied as a therapy for cancer. TAS-120 is a pill that you will take every day. You will see a doctor every 21 days, but you may have blood tests performed more often. You will have your cancer re-staged every 6-9 weeks.
Enrollment
Actively recruiting
Study Start Date
08/11/2014
Estimated Completion Date
12/31/2018
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
  • To determine the most appropriate dose of TAS-120 in patients with advanced solid tumors and multiple myeloma with genetic abnormalities
  • To investigate the safety and efficacy of TAS-120 in patients with advanced solid tumors and multiple myeloma with genetic abnormalities
Inclusion Criteria – Patients Must:
  • be 18 years of age or older
  • have advanced, metastatic solid tumor with measurable disease
  • have an FGFR gene fusion or activating mutation
  • be able to swallow pills
  • have adequate organ function as determined by routine blood work
Exclusion Criteria – Patients Must NOT:
  • have certain serious illnesses or medical conditions
  • have a history or current evidence of certain heart conditions
  • have a history of another primary malignancy that is currently clinically significant, has potential for metastases, or currently requires active intervention
  • be pregnant or lactating
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms
  • Doctor visit
  • blood and urine samples collected for routine tests
  • EKG
  • eye exam
  • CT or MRI scan
POTENTIAL SIDE-EFFECTS – in layman’s terms
  • increased phosphorus level
  • nail changes
  • skin rash/dryness/itching
  • hand-foot syndrome (palms of hand/soles of feet having pain, swelling, and blistering)
  • dry mouth/throat and/or skin
  • esophageal sores and/or mouth blisters/sores
  • dry eyes
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