This is a Phase I, open label, non randomized, multicenter study designed to investigate the safety and tolerability of escalating doses of OPB-111077 administered orally, once daily in subjects with advanced HCC.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Unnamed facility
Seoul & Gyeonggi-Do, South Korea
Safety of OPB-111077
Number of participants with adverse events as assessed by CTCAE v4.0
Time frame: Within the first cycle [24 days]
To investigate the maximum tolerated dose (MTD) of OPB-111077
• The highest dose that does not lead to discontinuation of dose escalation is defined as the MTD.
Time frame: Within the first cycle [24 days]
Pharmacokinetics (PK) properties of OPB-111077 and its metabolites.
The following PK parameters (Cmax (maximum observed concentration), AUC(area uder the concentration time curve from zero), tmax (Time to maximum plasma concentration), etc.) will be determined using a non-compartmental methods.
Time frame: Within the first cycle [24 days]
Tumor response measured by RECIST(Response Evaluation Criteria in Solid Tumor) 1.1
Assessment will be conducted at Screening, end of Cycle 1, end of Cycle 2, end of every 2 cycles thereafter, at the Early Termination (discontinuation) Visit.
Time frame: Approximately 3-18 weeks depending on tumor response
Biomarker of OPB-111077
Change from baseline on predictable biomarker specified in the protocol
Time frame: Within the first cycle [24 days]
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