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

Titre officiel

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

Sommaire:

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

Description de l'essai

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
Secondary Outcome:
  • 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)

Voir cet essai sur ClinicalTrials.gov

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