A Phase II Study of BGJ398 in Patients with Persistent Bile Duct Cancer Containing an FGFR Gene Alteration

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Full Title

A Phase II Multicenter, Single Arm Study of Oral BGJ398 in Adult Patients with Advanced or Metastatic Cholangiocarcinoma with FGFR2 Gene Fusions or Other FGFR Genetic Alterations Who Failed or are Intolerant to Platinum-based Chemotherapy

Purpose

BGJ398 is an investigational drug that inhibits a protein called “fibroblast growth factor receptor” (FGFR). Some bile duct cancers (cholangiocarcinomas) have an abnormality in the FGFR gene which makes the cancer especially reliant on this protein for growth. It is hoped that BGJ398 may be effective against bile duct cancers that contain this abnormality.

In this study, researchers are evaluating the safety and effectiveness of BGJ398 in patients with bile duct cancer that has continued to grow despite initial chemotherapy or who were unable to tolerate chemotherapy, and whose tumors contain an FGFR gene alteration. BGJ398 is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have bile duct cancer that has continued to grow despite prior therapy which included gemcitabine with or without cisplatin.
  • Patients’ tumors must contain an FGFR gene alteration.
  • Patients should recover from the serious side effects of prior therapies before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Maeve Lowery at 646-888-4543.

Protocol

14-183

Phase

II

Investigator

Co-Investigators