A Study of DCC-2618 vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib

Official Title

A Phase 3, Interventional, Randomized, Multicentre, Open-Label Study of DCC-2618 vs Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumours After Treatment With Imatinib

Summary:

This is a 2-arm, randomized, open-label, international, multicentre study comparing the efficacy of DCC-2618 to sunitinib in GIST patients who progressed on or were intolerant to first-line anticancer treatment with imatinib. Approximately 358 patients will be randomized in a 1:1 ratio to DCC-2618 150 mg once daily (QD) (continuous dosing for 6 week cycles) or sunitinib 50 mg QD (6 week cycles, 4 weeks on, 2 weeks off).

Trial Description

Primary Outcome:

  • Progression free survival (PFS)
Secondary Outcome:
  • Objective response rate (ORR)
  • Overall Survival (OS)

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