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A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma

Trial Status: Active

This is a multi-center, open label, single arm phase II study evaluating BGJ398 anti-tumor activity in advanced or metastatic cholangiocarcinoma patients with Fibroblast Growth Factor receptor (FGFR) genetic alterations.

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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 [1.0 x 109/L]
  • Platelets < 75,000/mm3 [75 x 109/L]
  • Hemoglobin < 109.0 g/dL
  • Total bilirubin > 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

Arizona

Scottsdale
Mayo Clinic in Arizona
Status: CLOSED_TO_ACCRUAL

California

Los Angeles
Los Angeles County-USC Medical Center
Status: ACTIVE
Contact: Charlean Ketchens
Phone: 323-865-3035
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
USC / Norris Comprehensive Cancer Center
Status: ACTIVE
San Francisco
UCSF Medical Center-Mount Zion
Status: CLOSED_TO_ACCRUAL

Illinois

Chicago
Northwestern University
Status: WITHDRAWN

Massachusetts

Boston
Dana-Farber Cancer Institute
Status: CLOSED_TO_ACCRUAL
Massachusetts General Hospital Cancer Center
Status: ACTIVE

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: CLOSED_TO_ACCRUAL

New York

New York
Icahn School of Medicine at Mount Sinai
Status: COMPLETED
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: CLOSED_TO_ACCRUAL
Memorial Sloan Kettering Cancer Center
Status: CLOSED_TO_ACCRUAL

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE
Contact: Milind Javle
Phone: 713-792-3245

Adult patients with histologically or cytologically confirmed advanced or metastatic

cholangiocarcinoma with FGFR2 gene fusions or translocations or other FGFR genetic

alterations who have evidence of radiologic progression following a cisplatin-and

gemcitabine-containing regimen for advanced disease or a gemcitabine-containing regimen for

those who are considered intolerant to cisplatin will be enrolled. Up to approximately 160

adult patients over age 18, both male and female will be enrolled. Three cohorts of patients

comprise the study population:

Cohort 1: patients with FGFR2 gene fusions or translocations and other FGFR genetic

alterations enrolled under the original protocol and amendment 1.

Cohort 2: patients with FGFR genetic alterations other than FGFR2 gene fusions or

translocations.

Cohort 3: patients with FGFR2 gene fusions or translocations who have received a prior FGFR

inhibitor.

All patients will receive oral BGJ398, once daily, on a three weeks on (21 days), one week

off (7 days) schedule. One treatment cycle will consists of 28 days.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
QED Therapeutics, Inc.

  • Primary ID CBGJ398X2204
  • Secondary IDs NCI-2014-01310, 2013-005085-19
  • Clinicaltrials.gov ID NCT02150967