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 and Adverse Events (AEs) at its worst grade
  • Incidence of Serious Adverse Events (SAEs) at its worst grade
  • Incidence of AEs leading to discontinuations
  • Incidence of AEs leading to death
  • Frequency 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)
  • Changes in Fridericia-corrected QT interval (ΔQTcF)
  • Frequency of different subject immunogenicity status
  • Cmax (maximum observed serum and/or plasma concentration)
  • Tmax (time of maximum observed serum and/or plasma concentration)
  • AUC(0-t) (area under the concentration-time curve from time 0 to time t)
  • AUC(TAU) (area under the concentration-time curve in 1 dosing interval)
  • Ctau (concentration at the end of a dosing interval)
  • Ctrough (trough observed serum and/or plasma concentration, including predose concentrations and Ctau concentrations)
  • CLT (total body clearance calculated as dose divided by AUC(TAU)
  • Vss (apparent volume of distribution at steady-state)
  • Vz (volume of distribution of terminal phase)
  • AI_Cmax (accumulation index; ratio of Cmax at steady-state to Cmax after the first dose)
  • AI_Ctau (accumulation index; ratio of Ctau at steady-state to Ctau after the first dose)

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society