A Phase III Study of DCC-2618 versus Placebo in Patients with Previously Treated Gastrointestinal Stromal Tumors (GIST)

Full Title

A Phase 3, Interventional, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of DCC-2618 In Patients with Advanced Gastrointestinal Stromal Tumors who have Received Treatment with Prior Anticancer Therapies

Purpose

Gastrointestinal stromal tumor (GIST) is a type of sarcoma that develops in the digestive system. In this study, researchers are evaluating the safety and effectiveness of the investigational drug DCC-2618 in people with GIST that has continued to grow despite prior therapy, due to changes in their genes. Genes are the instructions that tell cells in the body what to do. Cancer changes genes so that these instructions are no longer correct. DCC-2618 is designed to block signals from the genes that cause GIST to grow.

Patients in this study will be randomly assigned to receive DCC-2618 or a placebo (inactive pill). Patients receiving placebo whose cancer continues to grow during the study may be able to receive DCC-2618 instead. DCC-2618 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 GIST that has continued to grow despite prior treatment with imatinib, sunitinib, and regorafenib, or patients must have been unable to take these therapies.
  • At least 2 weeks must pass between the completion of prior therapies 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. Ping Chi at 646-888-4166.

Protocol

18-159

Phase

III

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators