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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
Clinical Trial Category (check all that apply)
  • Beyond First Line Therapy
  • Targeted Therapy
Study Center
Institution Name
QED Therapeutics, Inc
State
– Please Select –
Country
United States
Phone
(650) 231-4088
Website
https://www.qedtx.com
List additional Institutions (include address, phone number, and website)
For a list of participating clinical trial sites, please refer to the below clinicaltrials.gov link:

https://www.clinicaltrials.gov/ct2/show/NCT02150967

Study Contacts
Principal Investigator
QED Therapeutics, VP Clinical Development
P.I. Phone
(650) 231-4088
P.I. Email
clinicaltrials@QEDTx.com
Study Coordinator
QED Therapeutics, Director Clinical Operations
Study Coordinator Phone
(650) 231-4088
Study Coordinator Email
clinicaltrials@QEDTx.com
OVERVIEW – in layman’s terms (150 words max)
This is a global Phase 2 study for 2nd line treatment of patients with advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other FGFR genetic alteration. Patients must have been previously treated with gemcitabine chemotherapy or combination chemotherapy with gemcitabine.
Enrollment
Approximately 160 participants
Study Start Date
07/14/2019
Estimated Completion Date
07/31/2022
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
  • The reason for this study is to find out if the investigational product (oral BGJ398) is safe and has beneficial effects in people who have advanced cholangiocarcinoma (biliary tract cancer).
Inclusion Criteria – Patients Must:
  • Adult patients with histologically or cytologically confirmed cholangiocarcinoma at the time of diagnosis. Patients with cancers of the gallbladder or ampulla of Vater are not eligible.
  • 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.
  • Patients must have cholangiocarcinoma that has FGFR genetic mutations.
Exclusion Criteria – Patients Must NOT:
  • Prior or current treatment with a MEK inhibitor (all cohorts), BGJ398/infigratinib (all cohorts), or selective FGFR inhibitor (Cohorts 1 and 2 only).
  • Insufficient organ function: • Absolutely Neutrophil Count (ANC) < 1,000/mm3 • Platelets < 75,000/mm3 • Hemoglobin 1.5x ULN • Aspartate aminotransferase/glutamic oxaloacetic transaminase/GOT (AST/SGOT) and Alanine aminotransferase/glutamic pyruvic transaminase/GPT (ALT/SGPT) > 2.5x ULN (AST and ALT) > 5x upper limit of normal (ULN) in the presence of liver metastases) • Serum creatinine > 1.5x ULN and a calculated or measured creatinine clearance < 45 mL/min • Inorganic phosphorus outside of normal limits • Total and ionized serum calcium outside of normal limits
  • Other protocol-defined inclusion/exclusion criteria may apply
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms
  • Participants have to undergo molecular profiling to determine FGFR status. QED will pay for this testing.
POTENTIAL SIDE-EFFECTS – in layman’s terms
  • Elevated blood phosphate levels, tiredness, sore mouth, hair thinning
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