A study to evaluate safety and tolerability of BMS-986012 in patients with small cell lung cancer
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Local Institution
Takatsuki-shi, Osaka, Japan
Local Institution
Chuo-ku, Tokyo, Japan
Number of participants with adverse events (AEs)
Time frame: Up to 2 years
Number of participants with serious adverse events (SAEs )
Time frame: Up to 2 years
Number of Discontinuations due to AEs
Time frame: Up to 2 years
Number of Deaths due to AEs
Time frame: Up to 2 years
Number of participants with laboratory toxicity grade shift from baseline
Time frame: Up to 2 years
Maximum observed serum concentration (Cmax)
Time frame: Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose
Time of maximum observed serum concentration(Tmax)
Time frame: Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose
Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration(AUC(0-T))
Time frame: Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose
Observed serum concentration at the end of a dosing interval(Ctau)
Time frame: Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose
Area under the concentration-time curve in 1 dosing interval(AUC(TAU))
Time frame: Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose
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Characterization of Immunogenicity as measured by Anti-Drug Antibodies (ADA)
Time frame: Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose
Best overall response (BOR)
Time frame: Cycle 1(each cycle is 21 days) Day 1 up to approximately 2 years
Duration of response (DOR)
Time frame: Cycle 1(each cycle is 21 days) Day 1 up to approximately 2 years