check_circleStudy Completed
Lymphoma, Non-Hodgkin
Bayer Identifier:
16866
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Copanlisib Chinese PK study
Trial purpose
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.
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.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
13Trial Dates
April 2018 - June 2020Phase
Phase 1Could I Receive a placebo
NoProducts
Aliqopa (Copanlisib, BAY80-6946)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Beijing Cancer Hospital | Beijing, 100142, China |
Primary Outcome
- Cmax (Cycle 1 Day 1) of CopanlisibCmax: maximum observed drug concentration in measured matrix after single dose administrationdate_rangeTime 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 CopanlisibAUC: area under the concentration vs. time curve from zero to infinity after single (first) dosedate_rangeTime 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 Copanlisibdate_rangeTime 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 Copanlisibdate_rangeTime 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 Copanlisibdate_rangeTime Frame:Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11 and 24 hours after start of infusion
Secondary Outcome
- Overall response rate: proportion of patients with confirmed complete response (CR) and partial response (PR)date_rangeTime 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)date_rangeTime Frame:Up to about 6 months
- The number of serious drug-related TEAEs (treatment-emergent adverse events)date_rangeTime Frame:Up to about 7 months
- The number of non-serious drug-related TEAEsdate_rangeTime Frame:Up to about 7 months
- Cmax (Cycle 1 Day 1) of M-1 metabolitedate_rangeTime 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 metabolitedate_rangeTime 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 metabolitedate_rangeTime 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 metabolitedate_rangeTime 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 metabolitedate_rangeTime Frame:Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11 and 24 hours after start of infusion
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
Basic ScienceAllocation
N/ABlinding
N/AAssignment
Single Group AssignmentTrial Arms
1