A Phase III Study of Sunitinib with or without CGT9486 in People with Inoperable or Metastatic Gastrointestinal Stromal Tumors

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Full Title

(PEAK) A Phase 3 Randomized, Open-label, Multicenter Clinical Study of CGT9486+Sunitinib vs Sunitinib in Subjects with Locally Advanced, Unresectable or Metastatic Gastrointestinal Stromal Tumors (WCG)

Purpose

This study is assessing the effectiveness of adding the investigational drug CGT9486 (also known as bezuclastinib) to sunitinib treatment in people with inoperable or metastatic gastrointestinal stromal tumors (GIST) whose disease continues to grow despite treatment and who cannot tolerate imatinib. CGT9486 is designed to block mutations in a gene called KIT, which can cause cancer and promote cell growth. By blocking these mutations, CGT9486 may kill cancer cells with the mutation and/or stop the tumor from growing. 

Participants will be randomly assigned to one of several treatment groups in which sunitinib is given alone or with CGT9486. Both medications are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have inoperable or metastatic GIST that continues to grow despite treatment.
  • Patients must be unable to tolerate imatinib.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for people age 18 and older.

Contact

For more information about this study and to ask about eligibility, please contact the office of Dr. William Tap at 646-888-4163.

Protocol

22-229

Phase

III

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators