A Study of BBI608 Administered With Paclitaxel in Adult Patients With Advanced Malignancies

Official Title

A Phase Ib/II Clinical Study of BBI608 Administered With Paclitaxel in Adult Patients With Advanced Malignancies

Summary:

This is an open label, single arm phase 1 dose escalation study and phase 2 study of BBI608 in combination with paclitaxel in patients with advanced malignancies.

Trial Description

Primary Outcome:

  • Safety by reporting the adverse events and serious adverse events
  • Determination of the Recommended Phase 2 Dose by assessing dose-limiting toxicities (DLTs)
Secondary Outcome:
  • Preliminary anti-tumour activity of BBI608 when administered in combination with paclitaxel in patients with advanced malignancies by performing tumour assessments every 8 weeks
  • Pharmacokinetic profile of BBI608 and paclitaxel assessed by area under the plasma concentration versus time curve

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