This study aims to analyze what the study drug does to the body and its relationship to drug levels and safety after patients with advanced cancer have been treated with copanlisib in different dose groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
63
0.8 mg/kg body weight and 0.4 mg/kg (not to exceed 65 mg) for the non-diabetic patients;45 mg and 60 mg for the diabetic patients; Intravenous (IV) infusion over 1 hour. Dosing of copanlisib will be on Days 1, 8, and 15 of each 28 day treatment cycle.
Unnamed facility
Bruxelles - Brussel, Belgium
Unnamed facility
Bruxelles - Brussel, Belgium
Unnamed facility
Ghent, Belgium
Unnamed facility
Caen, France
Maximum change from baseline in expression of pathway inhibition (pAKT) in surrogate tissue (platelet rich plasma) during copanlisib monotherapy
Time frame: Baseline and approximately 2 years
Maximum change from baseline in plasma glucose during 2 cycles of copanlisib monotherapy
Time frame: Baseline and after day 22
AUC(0-168) of copanlisib after each copanlisib IV infusion during 2 cycles of copanlisib monotherapy
Time frame: After day 22
AEs as characterized by type, frequency, severity (as graded by CTCAE) and relationship to study drug
Time frame: Approximately 2 years
Maximum change from baseline in insulin during 2 cycles of copanlisib
Time frame: After day 22
Maximum change from baseline in C-peptide during 2 cycles of copanlisib
Time frame: After day 22
FDG PET early response (decreased SUVmax compared to baseline) after dosing with copanlisib for non-diabetic patients with detectable FDG tumor uptake at baseline
Time frame: After day 22
Change from baseline in expression and / or phosphorylation of PI3K pathway proteins in paired tumor biopsies
Time frame: Baseline and after day 22
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Unnamed facility
Lille, France
Unnamed facility
Nice, France
Unnamed facility
Pierre-Bénite, France
Unnamed facility
Sutton, Surrey, United Kingdom
Unnamed facility
London, United Kingdom