A Study of BBI503 in Combination With Selected Anti-Cancer Therapeutics in Adult Patients With Advanced Cancer

Official Title

A Phase Ib/II Clinical Study of BBI503 in Combination With Selected Anti-Cancer Therapeutics in Adult Patients With Advanced Cancer

Summary:

This is an open label, multi-centre, Phase 1/2 study of BBI503 administered in combination with selected anti-cancer therapeutics in adult patients with advanced cancer. The goal of the study is to determine the safety, tolerability, and RP2D of BBI503 in combination with each of the selected anti-cancer agents.

Trial Description

Primary Outcome:

  • Determination of the safety and tolerability of BBI503 administered in combination with selected anti-cancer therapeutics by assessing dose-limiting toxicities (DLTs)
  • Determination of the Recommended Phase 2 Dose (RP2D) by assessing dose-limiting toxicities (DLTs)
Secondary Outcome:
  • Assessment of the preliminary anti-tumour activity by performing tumour assessments every 8 weeks (Phase 2 portion)
  • Pharmacokinetic profile of BBI503 administered in combination with selected anti-cancer therapeutics as assessed by maximum plasma concentration and area under the curve
  • Pharmacodynamic activity of BBI503 administered in combination with selected anti-cancer therapeutics as assessed by biomarker analysis

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