A Phase IB Study of BGJ398 plus Imatinib in Patients with Persistent Gastrointestinal Stromal Tumor

Full Title

A Phase Ib/II Study of BGJ398 in Combination with Imatinib Mesylate in Patients with Untreated Advanced Gastrointestinal Stromal Tumor (GIST)

Purpose

Imatinib mesylate is a drug commonly used to treat gastrointestinal stromal tumor (GIST). However, in some patients GIST continues to grow despite imatinib. BGJ398 is an investigational drug that may help imatinib work better against GIST. BGJ398 works by inhibiting the “fibroblast growth factor receptor” pathway, a protein pathway which is believed to active when GIST becomes resistant to imatinib therapy.

In this study, researchers want to find the highest dose of BGJ398 that can be given safely with imatinib in patients with locally advanced or metastatic GIST that continued to grow despite imatinib. 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 locally advanced or metastatic GIST that continued to grow despite imatinib therapy.
  • 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 about this study and to inquire about eligibility, please contact Dr. William Tap at 646-888-4163.

Protocol

14-140

Phase

I/II

Investigator

Co-Investigators