drugset
drugset / Trial / NCT02024607

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

NCT02024607 ↗

Phase 1/2 Completed 495 enrolled Sumitomo Pharma America, Inc.
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2014-01
Primary completion
2019-03
Completion
2019-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 5 mg/kg Intravenous
Subject Capecitabine Small molecule 850 mg/m2 Oral
Subject Capecitabine Small molecule 1000 mg/m2 Oral
Subject Irinotecan Small molecule 180 mg/m2 Intravenous
Subject Leucovorin Small molecule 400 mg/m2 Intravenous
Subject Napabucasin Small molecule — Oral
Subject Oxaliplatin Small molecule 85 mg/m2 Intravenous
Subject Regorafenib Small molecule 120 mg Oral
Subject Regorafenib Small molecule 160 mg Oral
Subject fluorouracil Small molecule 400 mg/m2 Intravenous
Subject fluorouracil Small molecule 1200 mg/m2 Intravenous

Indications

digestive system cancer