check_circleStudy Completed

Treatment of cancer in patients with hepatic and/or renal impairment,

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

All

Age

18 - 80 Years

Trial summary

Enrollment Goal
30
Trial Dates
June 2017 - May 2020
Phase
Phase 1
Could I Receive a placebo
No
Products
Aliqopa (Copanlisib, BAY80-6946)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
CRS Clinical-Research-Services Kiel GmbHKiel, 24105, Germany
Withdrawn
CRS Clinical-Research-Services Mönchengladbach GmbHMönchengladbach, 41061, Germany
Completed
Institutul National de Boli Infectioase Prof.Dr.Matei BalsBucuresti, 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 infusion
    enhanced_encryption
    Safety Issue:
    No
  • 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 infusion
    enhanced_encryption
    Safety Issue:
    No
  • 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 infusion
    enhanced_encryption
    Safety Issue:
    No

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 infusion
    enhanced_encryption
    Safety Issue:
    No
  • 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 infusion
    enhanced_encryption
    Safety Issue:
    No
  • 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 drug
    enhanced_encryption
    Safety Issue:
    Yes
  • 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 drug
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

An open-label non-randomized, phase 1 single dose study to evaluate the pharmacokinetics and safety of copanlisib in subjects with impaired hepatic or renal function in comparison to healthy subjects
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Non-randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
4