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

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals; QED Therapeutics, Inc.
• Collaborator: Helsinn Healthcare SA
• Treatments: Infigratinib

Criteria

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

Other protocol-defined inclusion/exclusion criteria may apply.