A Phase II Study of INCB054828 in Patients with Metastatic or Inoperable Bile Duct Cancer

Full Title

A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FG

Purpose

The purpose of this study is to assess the safety and effectiveness of the investigational drug INCB054828 in patients with metastatic or inoperable cholangiocarcinoma (bile duct cancer) that continues to grow despite prior treatment. FGF/FGFR alternations are genetic abnormalities that result in the production of an abnormal fibroblast growth factor receptor (FGFR2) protein, which is believed to promote the growth and spread of cholangiocarcinoma. INCB054828 is designed to block the production of the abnormal FGFR2 protein in cancer cells. It 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 metastatic or inoperable cholangiocarcinoma that has continued to grow despite at least one prior regimen of therapy.
  • At least 4 weeks must pass between the completion of prior treatments and entry into the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Ghassan Abou-Alfa at 646-888-4184.

Protocol

17-405

Phase

II

Investigator

Co-Investigators

Diseases