A Phase II Multicenter, Single Arm Study of Oral BGJ398 in Adult Patients With Advanced or Metastatic Cholangiocarcinoma With FGFR2 Gene Fusions or Other FGFR Genetic Alterations Who Failed or Are Intolerant to Platinum-based Chemotherapy

Study Name
  A Phase II Multicenter, Single Arm Study of Oral BGJ398 in Adult Patients With Advanced or Metastatic Cholangiocarcinoma With FGFR2 Gene Fusions or Other FGFR Genetic Alterations Who Failed or Are Intolerant to Platinum-based Chemotherapy
ClinicalTrials.gov Identifier (if applicable)
  NCT02150967
Study Center
Institution Name
  Novartis Pharmaceuticals
Institution Address
  One Health Plaza
City
  East Hanover
State
  New Jersey
Zip Code
  07936
Phone
  (888) 669-6682
Website
  https://www.novartis.com/
Study Contacts
Principal Investigator
  TBD
P.I. Phone
  (888) 669-6682
P.I. Email
  novartis.email@novartis.com
List additional Principal Investigators (include phone number and email)
  Please refer to the Clinical Trials.gov listing and contact Novartis at 1-888-669-6682 for a research center near you
Study Coordinator
  TBD
Study Coordinator Phone
  (888) 669-6682
Study Coordinator Email
  novartis.email@novartis.com
List additional Study Coordinators (include phone number and email)
  Please refer to the Clinical Trials.gov listing and contact Novartis at 1-888-669-6682 for a research center near you
OVERVIEW – in layman’s terms (150 words max)
  This Phase II clinical trial will establish the effectiveness of BGJ398 in patients harboring the FGFR2 gene fusion/translocation, which are errors in the DNA.    Adult patients with histologically  or cytologically confirmed (tumor biopsy), advanced or metastatic cholangiocarcinoma harboring the FGFR2 gene fusion/ translocation are eligible for enrollment.  Phase II clinical trials give doctors more information about the safety of the drug and how well it works.

Approximately 55 adult patients over age 18, both male and female will be enrolled. All patients will receive oral BGJ398, once daily, on a three weeks on (21 days), one week off (7 days) schedule

Enrollment
  Actively recruiting
Study Start Date
  07/14/2014
Estimated Completion Date
  06/29/2020
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
 
  • Overall response rate
    The Overall response rate is determined by the proportion of patients experiencing a Complete Response or those patients with a Partial Response.
Inclusion Criteria – Patients Must:
 
  • Adult patients with histologically or cytologically confirmed cholangiocarcinoma at the time of diagnosis
  • Patients must have received at least one prior regimen containing gemcitabine with or without cisplatin for advanced/ metastatic disease. Patient should have evidence of progressive disease following prior regimen, or if prior treatment discontinued due to toxicity must have continued evidence of measurable or evaluable disease.
Exclusion Criteria – Patients Must NOT:
 
  • •Prior or current treatment with a MEK or selective FGFR inhibitor
  • •insufficient organ function

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