A Phase III Study of DCC-2618 versus Sunitinib in Patients with Advanced Gastrointestinal Stromal Tumors after Imatinib Treatment

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Full Title

A Phase 3, Interventional, Randomized, Multicenter, Open-Label Study of DCC-2618 vs Sunitinib in Patients with Advanced Gastrointestinal Stromal Tumors after Treatment with Imatinib (WIRB)

Purpose

Imatinib is a targeted therapy for gastrointestinal stromal tumors (GIST), but sometimes the cancer continues to grow. Sunitinib may be used in patients with GIST who cannot take imatinib or whose tumors continue to grow despite imatinib. In this study, researchers are comparing the investigational drug DCC-2618 with sunitinib in patients with advanced GIST that continues to grow despite imatinib.

Mutations in genes called KIT and PDGFRA can lead to cancer growth. DCC-2618 is designed to block signals from altered KIT and PDGFRA that cause cancers to grow. Both sunitinib and DCC-2618 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 advanced GIST that continues to grow despite imatinib.
  • 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. Ping Chi at 646-888-4166.

Protocol

19-104

Phase

III

Investigator

Co-Investigators