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

Titre officiel

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

Sommaire:

Il s'agit d'une étude ouverte, multicentrique de phase Ib à escalade de dose du BBI608, administré en association avec soit le FOLFOX6, avec ou sans bevacizumab, du CAPOX ou du FOLFIRI, avec ou sans bevacizumab, ou le régorafénib. Un cycle de l'étude comprendra l'administration quotidienne et continue du BBI608 pour quatre semaines (28 jours) en association avec le FOLFOX6, avec ou sans bevacizumab, du CAPOX ou du FOLFIRI, avec ou sans bevacizumab, ou le régorafénib.

Description de l'essai

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/XELIRI-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/XELIRI-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.

Voir cet essai sur ClinicalTrials.gov