A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma
- 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.
- 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
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
Cohort 3: patients with FGFR2 gene fusions or translocations who have received a prior FGFR
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 consist of 28 days.
Trial Phase Phase II
Trial Type Treatment
QED Therapeutics, Inc.
- Primary ID CBGJ398X2204
- Secondary IDs NCI-2014-01310, 2013-005085-19
- Clinicaltrials.gov ID NCT02150967