Study of Copanlisib in Hepatic or Renal Impairment

NCT ID: NCT03172884

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-14
• Study Completion Date: 2020-05-15

Brief Summary

To evaluate the pharmacokinetics and safety of copanlisib in subjects with impaired hepatic or renal function in comparison to healthy subjects

Conditions

Hepatic Insufficiency, Renal Insufficiency

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

BAY80-6946/Healthy subject

Healthy subjects

Group Type: EXPERIMENTAL

Copanlisib (ALIQOPA, BAY80-6946)

Intervention Type: DRUG

12mg single dose, intravenous on Day 0

BAY80-6946/moderate hepatically impaired patients

Patients with Child-Pugh B (score 7-9) at the screening visit

Group Type: EXPERIMENTAL

Copanlisib (ALIQOPA, BAY80-6946)

Intervention Type: DRUG

12mg single dose, intravenous on Day 0

BAY80-6946/severe renal impaired patients

Patients with eGFR 15-29 mL/min/1.73 m\^2 at the screening visit based on the Modification of Diet in Renal Disease (MDRD) equation

Group Type: EXPERIMENTAL

Copanlisib (ALIQOPA, BAY80-6946)

Intervention Type: DRUG

12mg single dose, intravenous on Day 0

BAY80-6946/severe hepatically impaired patients

Patients with Child-Pugh C (score 10-15) at the screening visit

Group Type: EXPERIMENTAL

Copanlisib (ALIQOPA, BAY80-6946)

Intervention Type: DRUG

12mg single dose, intravenous on Day 0

Interventions

Copanlisib (ALIQOPA, BAY80-6946)

12mg single dose, intravenous on Day 0

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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 or severe 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 (moderate) or Score 10 to 15 (severe).

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.

Exclusion Criteria

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, superficial bladder cancer as well as localized prostate cancer.
• Uncontrolled hypertension despite optimal medical management (per investigator's assessment).
• 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 or severe hepatic impairment

• Symptoms or history of encephalopathy (Grade III or worse)
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

CRS Clinical-Research-Services Kiel GmbH

Kiel, Schleswig-Holstein, Germany

Institutul National de Boli Infectioase Prof.Dr.Matei Bals

Bucharest, , Romania

Countries

Germany; Romania

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.clinicaltrialsregister.eu/

Click here to find information about studies related to Bayer Healthcare products conducted in Europe

http://clinicaltrials.bayer.com/

Click here to find results for studies related to Bayer Healthcare products.

Other Identifiers

2016-004561-51

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

18041

Identifier Type: -

Identifier Source: org_study_id