Condition
Advanced Cancer
Estimated Enrollment: 407
Age Group: 18 Years and older (Adult, Senior)
Gender: All
Study Type: Interventional
Study Design Allocation: Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: No masking|Primary Purpose: Treatment
Study ID Numbers: CA008-002|2014-002485-70
Study First Received: January 14, 2015
Last Updated: April 17, 2017
Estimated Primary Completion Date: April 2019
Primary Outcome Measures:
Safety is measured by incidence of adverse events (AEs) at its worst grade, serious adverse events (SAEs) at its worst grade, adverse events leading to discontinuations, deaths, frequency of laboratory test toxicity grade shifting from baseline|Maximum observed serum or plasma concentration (Cmax) of BMS-986148|Time of maximum observed serum or plasma concentration (Tmax) of BMS-986148|Concentration at the end of a dosing interval (Ctau) of BMS-986148|Trough observed serum or plasma concentration (this includes pre-dose concentrations and Ctau concentrations) (Ctrough) of BMS-986148|Area under the concentration-time curve from time 0 to time t (AUC(0-t)) of BMS-986148 (t= t last)|Area under the concentration-time curve in one dosing interval (AUC(TAU)) of BMS-986148|Terminal serum or plasma half-life (T-Half) of BMS-986148|Total body clearance calculated as Dose divided by AUC(TAU) (CLT) of BMS-986148|Volume of distribution at steady-state (Vss) of BMS-986148|Volume of distribution of terminal phase (Vz) of BMS-986148|Accumulation index; ratio of Cmax at steady-state to Cmax after the first dose (AI_Cmax) of BMS-986148|Accumulation index; ratio of Ctau at steady-state to Ctau after the first dose (AI_Ctau) of BMS-986148|Average concentration over a dosing interval calculated by dividing AUC(TAU) by tau (Cavg) of BMS-986148|Best overall response (BOR) of BMS-986148|Objective Response rate (ORR)|Duration of response|Progression free survival|Progression free survival rate|Overall survival|Overall survival rate|Changes in QTcF of BMS-986148|Immunogenicity of BMS-986148
Sponsors and Collaborators:
Bristol-Myers Squibb
Website Link: https://ClinicalTrials.gov/show/NCT02341625
