CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 30 enrolled
Drug / intervention
Copanlisib (ALIQOPA, BAY80-6946)drug
Likely dose
Copanlisib (ALIQOPA, BAY80-6946) 12mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03172884
NCT03172884Phase 1Completed
CompareCT.gov

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

Bayer·interventional·Posted Jun 1, 2017·Updated Apr 28, 2021

In Brief

A Phase 1 clinical trial evaluating Copanlisib (ALIQOPA, BAY80-6946) for Hepatic Insufficiency, Renal Insufficiency. Completed, enrolled 30 participants across 2 sites in 2 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatic Insufficiency, Renal Insufficiency
CountriesGermany, Romania
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedJun 1, 2017
Enrollment StartJun 14, 2017
Primary CompletionMar 13, 2020
Study CompletionMay 15, 2020
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 9.1 years ago

Interventions

Copanlisib (ALIQOPA, BAY80-6946)drug

12mg single dose, intravenous on Day 0