Last updated on November 2019

Study of Copanlisib in Hepatic or Renal Impairment

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Renal Cancer | Hepatic Insufficiency | Renal cancer
  • Age: Between 18 - 80 Years
  • Gender: Male or Female
  • Other:
    All subjects - Male and female subjects between 18 and 80 years of age with a body mass
    index above 18.0 and below 34.0 kg / m² and a body weight of above or equal 50 kg.
    Healthy subjects
    Healthy subjects as determined by absence of clinically significant deviation from normal
    in medical history, physical examination, vital signs, electrocardiograms, and clinical
    laboratory determinations. eGFR ≥ 90 mL/min/1.73 m² (according to Modification of Diet in
    Renal Disease [MDRD] formula).
    Subjects with moderate hepatic impairment
    Subjects with confirmed liver cirrhosis by at least one of the following criteria:
    histologically by prior liver biopsy showing cirrhosis, liver imaging (computer
    tomography, and/or ultrasound and/or magnetic resonance imaging scans, and/or
    fibroscan), or laparoscopy.
    Child-Pugh Clinical Assessment Score 7 to 9. Subjects with severe renal impairment
    Subjects with severe renal impairment with an estimated glomerular filtration rate
    15-29 mL/min/1.73 m² according to MDRD formula.
    Subjects with stable renal disease: no significant change in renal function as
    evidenced by serum creatinine value within ±25% from the last determination, obtained
    within at least 3 months before study entry and the absence of the need to start
    dialysis in the next 3 months.

You may not be eligible for this study if the following are true:

  • All subjects
    Active coronary artery disease or myocardial infarction within 6 months of study
    entry. Immuno-compromised subjects including known history/seropositivity of human
    immunodeficiency virus (HIV).
    Other concurrent severe and/or uncontrolled medical conditions (e.g. current diagnosis
    of type 1 or type 2 diabetes mellitus and with HbA1c >8.5%) that could cause
    unacceptable safety risks or compromise compliance with protocol.
    Previous or concurrent history of malignancies within 5 years prior to study treatment
    except for curatively treated cervical cancer in situ, non-melanoma skin cancer,
    uperficial bladder cancer as well as localized prostate cancer.
    Uncontrolled hypertension despite optimal medical management (per investigator's
    Administration of strong CYP3A4 inhibitors or inducers within 2 weeks prior to dosing
    and during study conduct. (A list of these medications can be found in Section 16.6 of
    the protocol. However, this list may not be comprehensive).Subjects with moderate
    hepatic impairment
    Symptoms or history of encephalopathy
    Failure of any other major organ other than the liver; severe infection, or any
    clinically significant illness within 4 weeks prior to study drug administration
    Renal failure with an eGFR <35 mL/min/1.73 m² Subjects with severe renal impairment
    Acute renal failure at study entry
    Nephrotic syndrome
    Failure of any other major organ other than the kidney
    Acute hepatorenal syndrome

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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