CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 200 enrolled
Drug / intervention
BBI608 +3 moredrug
Likely dose
BBI608 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01776307
NCT01776307Phase 2Completed
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A Phase II Clinical Study of BBI608 in Adult Patients With Advanced Colorectal Cancer

Sumitomo Pharma America, Inc.·interventional·Posted Jan 28, 2013·Updated Nov 15, 2023

In Brief

A Phase 2 clinical trial evaluating BBI608, Panitumumab, and 2 other interventions for Colorectal Cancer. Completed, enrolled 200 participants across 13 sites.

Detailed Summary

This is an open label, multi-center, Phase 2 study of BBI608 in combination with cetuximab, panitumumab or capecitabine in patients with advanced colorectal cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 28, 2013
Enrollment StartMar 1, 2012
Primary CompletionJun 1, 2018
Study CompletionApr 1, 2020
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 13.4 years ago

Interventions

BBI608drug

BBI608 is administered at 500 mg po bid continuously.

Panitumumabdrug

Panitumumab will be administered IV on day 8 and 22 of each 28 day cycle at 6 mg/kg over 60 minutes.

Capecitabinedrug

Capecitabine will be administered orally at 1000 mg/m2 bid daily on days 8-21 every three weeks.

Cetuximabdrug

Cetuximab will be administered IV on day 5 at 400 mg/m2 intravenous infusion over 120 minutes as the initial dose, then weekly at 250mg/m2 over 60-minutes at subsequent cycles.