Open for enrollment:
University of Texas/MD Anderson Cancer Center Onc. Dept.
Houston, Texas, US
Contact: Samia Aziz 713-563-7757
Prinicipal Investigator: Dr. Milind Javle
A Phase II, Single Arm Study of BGJ398 in Patients with advanced Cholangiocarcinoma
Molecularly targeted therapy for patients with progressive and/ or metastasized cholangiocarcinoma.
Phase II: drug given to a larger group of people to see if it is effective and to further evaluate its safety.
Single Arm: everyone enrolled receives the same experimental therapy
Oral Drug BGJ398: taken by mouth
Open Label: both the health providers and the patients are aware of the drug or treatment being given.
Required tumor sample must present with FGFR2 gene fusions/translocations or other FGFR molecular genetic alterations.
Patients must have progressed or not responded to at least one chemotherapy treatment with gemcitabine with or without cisplatin.