check_circleStudy Completed

Non Hodgkin Lymphoma

Copanlisib pharmacodynamic study

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - 100 Years

Trial summary

Enrollment Goal
63
Trial Dates
August 2014 - March 2017
Phase
Phase 1
Could I Receive a placebo
No
Products
Aliqopa (Copanlisib, BAY80-6946)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
LILLE, 59037, France
Completed
BRUXELLES - BRUSSEL, 1000, Belgium
Completed
BRUXELLES - BRUSSEL, 1200, Belgium
Completed
GENT, 9000, Belgium
Completed
CAEN CEDEX 5, 14076, France
Completed
PIERRE BENITE, 69495, France
Completed
Sutton, SM2 5PT, United Kingdom
Completed
London, W1G 6AD, United Kingdom
Completed
NICE CEDEX 2, 06102, France

Primary Outcome

  • Maximum change from baseline in expression of pathway inhibition (pAKT) in surrogate tissue (platelet rich plasma) during copanlisib monotherapy
    date_rangeTime Frame:
    Baseline and approximately 2 years
    enhanced_encryption
    Safety Issue:
    No
  • Maximum change from baseline in plasma glucose during 2 cycles of copanlisib monotherapy
    date_rangeTime Frame:
    Baseline and after day 22
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • AUC(0-168) of copanlisib after each copanlisib IV infusion during 2 cycles of copanlisib monotherapy
    date_rangeTime Frame:
    After day 22
    enhanced_encryption
    Safety Issue:
    No
  • AEs as characterized by type, frequency, severity (as graded by CTCAE) and relationship to study drug
    date_rangeTime Frame:
    Approximately 2 years
    enhanced_encryption
    Safety Issue:
    No
  • Maximum change from baseline in insulin during 2 cycles of copanlisib
    date_rangeTime Frame:
    After day 22
    enhanced_encryption
    Safety Issue:
    Yes
  • Maximum change from baseline in C-peptide during 2 cycles of copanlisib
    date_rangeTime Frame:
    After day 22
    enhanced_encryption
    Safety Issue:
    Yes
  • FDG PET early response (decreased SUVmax compared to baseline) after dosing with copanlisib for non-diabetic patients with detectable FDG tumor uptake at baseline
    date_rangeTime Frame:
    After day 22
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in expression and / or phosphorylation of PI3K pathway proteins in paired tumor biopsies
    date_rangeTime Frame:
    Baseline and after day 22
    enhanced_encryption
    Safety Issue:
    No

Trial design

A Phase I pharmacodynamic study of copanlisib (BAY 80-6946) as monotherapy in patients with non-Hodgkin’s lymphoma and solid tumors
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2