CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 97 enrolled
Drug / intervention
BBI608 +2 moredrug
Likely dose
Sorafenib 400 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/NCT02279719
NCT02279719Phase 2Completed
CompareCT.gov

A Phase Ib/II Clinical Study of BBI608 in Combination With Sorafenib, or BBI503 in Combination With Sorafenib in Adult Patients With Hepatocellular Carcinoma

Sumitomo Pharma America, Inc.·interventional·Posted Oct 31, 2014·Updated Nov 15, 2023

In Brief

A Phase 2 clinical trial evaluating BBI608, BBI503, and 1 other intervention for Hepatocellular Carcinoma. Completed, enrolled 97 participants across 29 sites.

Detailed Summary

This is an open label, three-arm, phase 1 dose escalation study and phase 2 study of BBI608 in combination with sorafenib, or BBI503 in combination with sorafenib. The study population is adult patients with advanced hepatocellular carcinoma who have not received systemic chemotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatocellular Carcinoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 31, 2014
Enrollment StartDec 1, 2014
Primary CompletionJul 1, 2019
Study CompletionOct 1, 2019
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 11.7 years ago

Interventions

BBI608drug

BBI608 will be administered in combination with sorafenib at the RP2D determined during the phase 1 dose-escalation portion of study.

BBI503drug

BBI503 will be administered in combination with sorafenib at the RP2D determined during the phase 1 dose-escalation portion of study.

Sorafenibdrug

Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.