Phase 3 Study of DCC-2618 vs Placebo in Advanced GIST Patients Who Have Been Treated With Prior Anticancer Therapies

Official 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

Summary:

This is a 2‑arm, randomized, placebo-controlled, double‑blind, international, multicentre study comparing the efficacy of DCC-2618 to placebo in patients who have received treatment with prior anticancer therapies. Prior anticancer therapies must include imatinib, sunitinib, and regorafenib (3 prior therapies). Approximately 120 patients will be randomized in a 2:1 ratio to DCC‑2618 150 mg QD or placebo

Trial Description

Primary Outcome:

  • Progression free survival (PFS)
Secondary Outcome:
  • Objective response rate (ORR)
  • Time to Tumour Progression (TTP) based on independent radiologic review
  • Overall Survival (OS)
  • Time to best response
  • Progression Free Survival (PFS)
  • Quality of Life
  • Disease control rate (DCR)

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society