Copanlisib pharmacodynamic study
Research type
Research Study
Full title
A Phase I pharmacodynamic study of copanlisib (BAY 80-6946) as monotherapy in patients with non-Hodgkin’s lymphomas and solid tumors
IRAS ID
156947
Contact name
David Cunningham
Contact email
Sponsor organisation
Bayer HealthCare AG, 51368 Leverkusen, Germany
Eudract number
2013-004746-42
Research summary
Patients diagnosed with an advanced non-Hodgkin’s lymphoma, or an advanced and/or relapsed solid tumour will be invited to participate on this study. The purpose of this study is to evaluate the relationship between pharmacokinetic (what the body does to the drug) and pharmacodynamic markers (what the drug does to the body) of BAY 80-6946 (also called copanlisib) in patients with non-Hodgkin’s lymphomas and solid tumours after 2 cycles of copanlisib treatment. Patients will be randomly given one of the following treatments, copanlisib: 0.4 mg/kg or 0.8 mg/kg if they are not diabetic; 45 mg or 60 mg, if they are diabetic. Patients will continue receiving treatment until tumour progression, unacceptable toxicity, consent withdrawal, or withdrawal from the study at the discretion of the investigator or his / her designated associate(s). The study will be open label, which means both the patient and the study doctor will know which treatment option the patient is on. The main objective of this study is to evaluate the relationship between exposure and pharmacodynamics after treatment with copanlisib monotherapy in patients with non-Hodgkin’s lymphoma or solid tumours with high likelihood of phosphatidylinositol-3-kinase pathway activation.
About 52 patients in total, from three countries, are anticipated to participate in this study.REC name
London - Riverside Research Ethics Committee
REC reference
14/LO/1532
Date of REC Opinion
6 Nov 2014
REC opinion
Further Information Favourable Opinion