The purpose of this study is to assess the safety and tolerability of BMS-986004 when administered in subjects with ITP.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
BMS-986004 (75 mg) infusion (50 ml) administered in 120 minutes
BMS-986004 (225 mg) infusion (100 ml) administered in 120 minutes
BMS-986004 (675 mg) infusion (100 ml) administered in 120 minutes
Univ. Of Southern Calif. /Norris Comprehensive Cancer Center
Los Angeles, California, United States
Georgetown University Medical Center
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Short Term and Long Term
The primary objective to establish safety was measured by the primary endpoints of AEs and SAEs for both Short term and Long term periods
Time frame: Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term)
Number of ECG Abnormalities
The primary objective to establish safety was measured by investigator identified Electrocardiogram Abnormalities for both Short term and Long term periods. ECG parameters included heart rate, PR interval, QRS interval, and QTcF interval (QT interval corrected for heart rate)
Time frame: Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term)
Number of Laboratory Abnormalities of Safety Biomarkers: d-Dimer and Thrombin Anti-Thrombin (TAT)
D-dimer and thrombin antithrombin (TAT) in plasma were quantified as measures of thromboembolism risk. D-dimer was evaluated by Enzyme linked immune sorbent assay (ELISA) method (D-dimer reference range 0-0.63 micrograms/milliliters fibrinogen equivalent units \[mcg/ml FEU\]). TAT reference range 0-4.1 ng/ml.
Time frame: Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long Term)
Response Rate (RR) of BMS-986004: Short Term and Long Term
Overall Response Rate (ORR) was defined as the proportion of participants who achieved a complete response (CR) or response (R). CR was defined as platelet count ≥ 100,000/mm3 and absence of bleeding. R was defined as platelet count ≥ 30,000/mm3 and at least 2-fold increase from the baseline count and absence of bleeding.
Time frame: Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term)
Maximum Observed Serum Concentration (Cmax) of BMS-986004
Pharmacokinetic parameter (Cmax) of BMS-986004, derived from serum concentration versus time. who have adequate PK profiles. On study Day 57, non-responders in each treatment group other than the 1500 mg group were dose escalated to the starting dose of the next higher treatment group.
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BMS-986004 (1500 mg) infusion (100 ml) administered in 120 minutes
Washington D.C., District of Columbia, United States
Emory University
Atlanta, Georgia, United States
Columbus Regional Research Institute
Columbus, Georgia, United States
Mass General Hospital
Boston, Massachusetts, United States
Rutgers- Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Local Institution
Randwick, New South Wales, Australia
Local Institution
Brisbane, Queensland, Australia
Hamilton Health Sciences/Mc Master Univ Med Ctre
Hamilton, Ontario, Canada
Local Institution
Tbilisi, Georgia
...and 10 more locations
Time frame: Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h)
Area Under the Concentration-time Curve in One Dosing Interval [AUC(TAU)] of BMS-986004
Pharmacokinetics of BMS-986004 were derived from serum concentration versus time data. AUC(TAU) = Area under the concentration-time curve in one dosing interval. On study Day 57, non-responders in each treatment group other than the 1500 mg group were dose escalated to the starting dose of the next higher treatment group.
Time frame: Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h)
Trough Observed Serum Concentration (Ctrough) of BMS-986004
Pharmacokinetics of BMS-986004 were derived from serum concentration versus time data. Ctrough = Trough observed serum concentration. On study Day 57, non-responders in each treatment group other than the 1500 mg group were dose escalated to the starting dose of the next higher treatment group.
Time frame: Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h)
Total Body Clearance (CLT) of BMS-986004
Pharmacokinetics of BMS-986004 were derived from serum concentration versus time data. On study Day 57, non-responders in each treatment group other than the 1500 mg group were dose escalated to the starting dose of the next higher treatment group.
Time frame: Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h)
AUC Accumulation Index (AI_AUC) of BMS-986004
AUC accumulation index (AI\_AUC) = ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose of BMS-986004. On study Day 57, non-responders in each treatment group other than the 1500 mg group were dose escalated to the starting dose of the next higher treatment group.
Time frame: Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h)