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)

• 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