A Phase III Study of Avapritinib (BLU-285) versus Regorafenib in Patients with Locally Advanced Inoperable or Metastatic Gastrointestinal Stromal Tumor (GIST)

Full Title

An International, Multicenter, Open-label, Randomized, Phase 3 Study of BLU-285 vs Regorafenib in Patients with Locally Advanced Unresectable or Metastatic Gastrointestinal Stromal Tumor (GIST)

Purpose

Gastrointestinal stromal tumor (GIST) is a type of sarcoma that is usually treated with a drug called imatinib. When GIST continues to grow despite imatinib and similar drugs, it is then usually treated with a medication called regorafenib, but in some patients the cancer keeps growing. In this study, researchers want to determine if the investigational drug avapritinib is more effective than regorafenib in patients with inoperable or metastatic GIST that persists despite imatinib and another targeted therapy.

Avapritinib works by inhibiting enzymes that drive the growth of GIST. Patients will be randomly assigned to receive avapritinib or regorafenib. Both drugs are 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 inoperable or metastatic GIST that continues to grow despite imatinib and one or two other tyrosine kinase inhibitors (like sunitinib).
  • Patients may not have previously received regorafenib or avapritinib.
  • 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 and to inquire about eligibility for this study, please contact Dr. William Tap at 646-888-4163.

Protocol

18-278

Phase

III

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators