Clinical Trials Directory

Trials / Completed

CompletedNCT02024607

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

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

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
495 (actual)
Sponsor
Sumitomo Pharma America, Inc. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This is an open label, multi-center, 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.

Detailed description

This is an open label, multi-center, 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.

Conditions

Interventions

TypeNameDescription
DRUGBBI608
DRUGFluorouracil
DRUGOxaliplatin
DRUGLeucovorin
DRUGIrinotecan
DRUGBevacizumab
DRUGCapecitabine
DRUGRegorafenib

Timeline

Start date
2014-01-01
Primary completion
2019-03-01
Completion
2019-11-01
First posted
2013-12-31
Last updated
2023-11-15
Results posted
2021-09-20

Locations

15 sites across 2 countries: United States, Canada

Source: ClinicalTrials.gov record NCT02024607. Inclusion in this directory is not an endorsement.