This is an open-label, multicenter, phase 1 study of BBI608 in combination with Sorafenib. This study population is adult Japanese patients with advanced hepatocellular carcinoma in Sorafenib combination therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
4 Sites
Tokyo,etc, Japan
Assessment of safety and tolerability of BBI608 given in combination with Sorafenib by reporting of adverse events and serious adverse events.
Time frame: 7 month
Assessment of dose-limiting toxicities (DLTs).
Time frame: 29 days
Pharmacokinetic profile of BBI608 when administered in combination with Sorafenib.
Time frame: On day 1: Prior to BBI608 dosing and 2,4,6,8,10,12 and 24 hours after the first dose. On day 29: Prior to BBI608 dosing and 2,4,6,8,10,12 and 24 hours after the first dose.
Assessment of the preliminary anti-tumour activity.
Anti-tumour activity is assessed every 8 weeks from the first dose of BBI608 after the last dose of BBI608.The radiologic assessments will be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and modified RECIST for patients with hepatocellular carcinoma.
Time frame: Approximately 7 months
Progression Free Survival
The time the participant stays on study until progression will be measured and recorded.
Time frame: Approximately 7 month
Overall Survival
Participants follow-up for overall survival will occur. Maximum follow-up time is 1 year after the initial administration of the last subject.
Time frame: Approximately 1 year
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