A Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Advanced Gastrointestinal Cancer

Official Title

A Phase Ib/II Clinical Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Advanced Gastrointestinal Cancer

Summary:

This is an open label, multi-centre, Phase 1/2 dose escalation study of BBI608 administered in combination with either FOLFOX6 with and without bevacizumab, or CAPOX, or FOLFIRI with and without bevacizumab, or regorafenib, or irinotecan.

Trial Description

Primary Outcome:

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability
  • To assess the objective response rate (ORR) of BBI608 administered in combination with FOLFIRI in patients with FOLFIRI-refractory metastatic colorectal cancer (mCRC)
Secondary Outcome:
  • Pharmacokinetic profile of BBI608 assessed by maximum plasma concentration and area under the curve
  • Pharmacodynamic activity assessed by tumour biopsy
  • Anti-tumour activity by performing tumour assessments every 8 weeks
  • To assess the disease control rate (DCR), progression free survival (PFS) and overall survival (OS) of BBI608 administered in combination with FOLFIRI in patients with FOLFIRI-refractory mCRC
This is an open label, multi-centre, Phase 1/2 dose escalation study of BBI608 administered in combination with either FOLFOX6 with and without bevacizumab, or CAPOX, or FOLFIRI with and without bevacizumab, or regorafenib, or irinotecan. A study cycle will consist of daily and continuous oral administration of BBI608 for four weeks (28 days) in combination with FOLFOX6 with and without bevacizumab, or CAPOX, or FOLFIRI with and without bevacizumab, or regorafenib, or irinotecan.

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