A Study of the Safety and Tolerability of BMS-986183 in Patients With Liver Cancer

Official Title

A Phase 1/2 Study of BMS-986183 in Subjects With Advanced Hepatocellular Carcinoma

Summary:

The purpose of this study is to evaluate the safety and tolerability of BMS-986183 in patients with liver cancer.

Trial Description

Primary Outcome:

• Incidence of Adverse Events at Its Worst Grade
• Incidence of Serious Adverse Events at Its Worst Grade
• Incidence of Adverse Events Leading to Discontinuation
• Incidence of Adverse Events Leading to Death
• Incidence of Laboratory Test Toxicity Grade Shifting From Baseline

• Best Overall Response (BOR)
• Overall Response Rate (ORR)
• Duration of Response (DoR)
• Progression Free Survival (PFS)
• PFS Rate at Week 't'
• Maximum Observed Concentration (Cmax)
• Time of Maximum Observed Concentration (Tmax)
• Area Under the Concentration-time Curve From Time 0 to T of the Last Quantifiable Concentration [AUC(0-T)]
• Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)]
• Concentration at the End of a Dosing Interval (Ctau)
• Trough Observed Concentration, Including Predose Concentrations and Ctau (Ctrough)
• Total Body Clearance (CLT)
• Apparent Volume of Distribution at Steady-state (Vss)
• Volume of Distribution of Terminal Phase (Vz)
• Accumulation Index; Ratio of Cmax at Steady-state to Cmax After the First Dose (AI_Cmax)
• Accumulation Index; Ratio of Ctau at Steady-state to Ctau After the First Dose (AI_Ctau)
• Accumulation Index; Ratio of AUC(TAU) at Steady-state to AUC(TAU) After the First Dose [AI_AUC(TAU)]
• Average Concentration Over a Dosing Interval Calculated by Dividing AUC(TAU) at Steady State by Tau (Css,Ave)
• Terminal Half-life (T-HALF)
• Changes in QTcF (ΔQTcF) From Baseline
• Incidence of Positive Anti-drug Antibody (ADA)

View this trial on ClinicalTrials.gov