check_circleStudy Completed
Treatment of cancer in patients with hepatic and/or renal impairment,
Bayer Identifier:
18041
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Study of copanlisib in hepatic or renal impairment
Trial purpose
To evaluate the pharmacokinetics and safety of copanlisib in subjects with impaired hepatic or renal function in comparison to healthy subjects
Key Participants Requirements
Sex
AllAge
18 - 80 YearsTrial summary
Enrollment Goal
30Trial Dates
June 2017 - May 2020Phase
Phase 1Could I Receive a placebo
NoProducts
Aliqopa (Copanlisib, BAY80-6946)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | CRS Clinical-Research-Services Kiel GmbH | Kiel, 24105, Germany |
Withdrawn | CRS Clinical-Research-Services Mönchengladbach GmbH | Mönchengladbach, 41061, Germany |
Completed | Institutul National de Boli Infectioase Prof.Dr.Matei Bals | Bucuresti, 021105, Romania |
Primary Outcome
- Maximum observed concentration (Cmax) of Copanlisib in plasma.Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.date_rangeTime Frame:before copanlisib administration as well as 10 min and 1 h (end of infusion), 1.5, 2, 2.5, 3, 5, 8, 24, 48, 72, 96, 120 and 168 h after start of infusionenhanced_encryptionNoSafety Issue:
- Area under the concentration vs. time curve from zero to infinity (AUC) of Copanlisib in plasma.AUC refers to area under the concentration vs time curve from 0 to infinity which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.date_rangeTime Frame:before copanlisib administration as well as 10 min and 1 h (end of infusion), 1.5, 2, 2.5, 3, 5, 8, 24, 48, 72, 96, 120 and 168 h after start of infusionenhanced_encryptionNoSafety Issue:
- Area Under the Concentration-time Curve of copanlisib in plasma Over the Time Interval from 0 to 168 h.AUC(0-168) refers to AUC from time 0 to 168 hr which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.date_rangeTime Frame:before copanlisib administration as well as 10 min and 1 h (end of infusion), 1.5, 2, 2.5, 3, 5, 8, 24, 48, 72, 96, 120 and 168 h after start of infusionenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Maximum observed concentration (Cmax) of metabolite M-1.The morpholinone derivative M-1 is a minor copanlisib metabolite in plasma. The PK of metabolite M-1 is routinely analyzed in addition to the PK of the parent compound, although M-1 is not considered to be a major metabolite. Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.date_rangeTime Frame:before copanlisib administration as well as 10 min and 1 h (end of infusion), 1.5, 2, 2.5, 3, 5, 8, 24, 48, 72, 96, 120 and 168 h after start of infusionenhanced_encryptionNoSafety Issue:
- Area Under the Concentration-time Curve of metabolite M-1 in plasma Over the Time Interval from 0 to 168 h.The morpholinone derivative M-1 is a minor copanlisib metabolite in plasma. The PK of metabolite M-1 is routinely analyzed in addition to the PK of the parent compound, although M-1 is not considered to be a major metabolite. AUC from time 0 to 168h which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.date_rangeTime Frame:before copanlisib administration as well as 10 min and 1 h (end of infusion), 1.5, 2, 2.5, 3, 5, 8, 24, 48, 72, 96, 120 and 168 h after start of infusionenhanced_encryptionNoSafety Issue:
- Number of subjects with treatment-emergent adverse events (TEAEs)Adverse events are considered to be treatment-emergent if they have started or worsened after first application of study medication up to 30 days after end of treatment with study medication.date_rangeTime Frame:Up to 30 days after end of treatment with study drugenhanced_encryptionYesSafety Issue:
- Number of subjects with treatment-emergent adverse events (TEAEs) in different severity.Adverse events are considered to be treatment-emergent if they have started or worsened after first application of study medication up to 30 days after end of treatment with study medication.date_rangeTime Frame:Up to 30 days after end of treatment with study drugenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
Non-randomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
4