A Study of BBI503 in Adult Patients With Advanced Gastrointestinal Stromal Tumours

Official Title

A Phase II Clinical Study of BBI503 in Adult Patients With Advanced Gastrointestinal Stromal Tumours

Summary:

This is an open label, multi-centre, phase II study of BBI503 administered to adult patients with advanced gastrointestinal stromal tumour who have exhausted all currently approved standard anti-cancer treatment options. BBI503 will be administered orally, daily, in continuous 28-day cycles at a dose of 300 mg once daily. Cycles will be repeated until patients are no longer clinically benefiting from therapy due to disease progression, adverse events, or another discontinuation criterion. Safety, tolerability and efficacy of BBI503 will be assessed for the duration of study treatment.

Trial Description

Primary Outcome:

  • Disease Control Rate (DCR)
Secondary Outcome:
  • Objective Response Rate (ORR)
  • Progression Free Survival (PFS)
  • Overall Survival (OS)
  • Number of Patients with Adverse Events
  • Pharmacodynamics (biomarkers) of BBI503 when tumour biopsy is possible

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