A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma
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.
- Advanced Cholangiocarcinoma
- FGFR2 Gene Mutation
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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
Other protocol-defined inclusion/exclusion criteria may apply.
- Phase 2
- Study Type
- Intervention Model
- Single Group Assignment
- Primary Purpose
- None (Open Label)
|To estimate anti-tumor activity of BGJ398||
- NCT ID
- QED Therapeutics, Inc.
Study ContactQED Therapeutics
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: ~120 patients, 108 with FGFR2 gene fusions or translocations and 12 with other FGFR genetic alterations enrolled under the original protocol and amendment 1.
Cohort 2: ~20 patients with FGFR genetic alterations other than FGFR2 gene fusions or translocations.
Cohort 3: Up to ~20 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.