This study will be conducted primarily to determine the pharmacokinetics of copanlisib in Chinese patients with relapsed iNHL. The primary objective of the study is to determine the pharmacokinetics of copanlisib administered on Day1, 8, and 15 of a 28-days cycle (3 weeks-on/1 week off dosing regimen) as a 1 hour intravenous infusion to Chinese patients with relapsed iNHL. The secondary objectives include the evaluation of safety, tolerability, and tumor response of Chinese patients treated with Copanlisib. Determine the pharmacokinetics of M-1 metabolite.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
13
Copanlisib will be administered intravenously on 60mg once in a 3 weeks-on/1 week-off dose regimen (on Days 1, 8 and 15)
Beijing Cancer Hospital
Beijing, China
Cmax (Cycle 1 Day 1) of Copanlisib
Cmax: maximum observed drug concentration in measured matrix after single dose administration
Time frame: Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11, 24, 48, 72, 120 and 168 hours after start of infusion
AUC(0-24) (Cycle 1 Day 1) of Copanlisib
AUC: area under the concentration vs. time curve from zero to infinity after single (first) dose
Time frame: Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11, 24, 48, 72, 120 and 168 hours after start of infusion
AUC(0-tlast) (Cycle 1 Day 1) of Copanlisib
Time frame: Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11, 24, 48, 72, 120 and 168 hours after start of infusion
Cmax (Cycle 1 Day 15) of Copanlisib
Time frame: Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11 and 24 hours after start of infusion
AUC(0-24) (Cycle 1 Day 15) of Copanlisib
Time frame: Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11 and 24 hours after start of infusion
Overall response rate: proportion of patients with confirmed complete response (CR) and partial response (PR)
Time frame: Up to about 6 months
Overall disease control rate: proportion of patients who have a best response rating of CR, PR or stable disease (SD)
Time frame: Up to about 6 months
The number of serious drug-related TEAEs (treatment-emergent adverse events)
Time frame: Up to about 7 months
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The number of non-serious drug-related TEAEs
Time frame: Up to about 7 months
Cmax (Cycle 1 Day 1) of M-1 metabolite
Time frame: Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11, 24, 48, 72, 120 and 168 hours after start of infusion
AUC(0-24) (Cycle 1 Day 1) of M-1 metabolite
Time frame: Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11, 24, 48, 72, 120 and 168 hours after start of infusion
AUC(0-tlast) (Cycle 1 Day 1) of M-1 metabolite
Time frame: Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11, 24, 48, 72, 120 and 168 hours after start of infusion
Cmax (Cycle 1 Day 15) of M-1 metabolite
Time frame: Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11 and 24 hours after start of infusion
AUC(0-24) (Cycle 1 Day 15) of M-1 metabolite
Time frame: Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11 and 24 hours after start of infusion