NCT02155582

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2014

Typical duration for phase_1

Geographic Reach
3 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

August 12, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2017

Completed
Last Updated

June 16, 2017

Status Verified

June 1, 2017

Enrollment Period

2.1 years

First QC Date

June 2, 2014

Last Update Submit

June 15, 2017

Conditions

Non Hodgkin Lymphoma

Keywords

Solid tumors

Outcome Measures

Primary Outcomes (2)

  • Maximum change from baseline in expression of pathway inhibition (pAKT) in surrogate tissue (platelet rich plasma) during copanlisib monotherapy

    Baseline and approximately 2 years

  • Maximum change from baseline in plasma glucose during 2 cycles of copanlisib monotherapy

    Baseline and after day 22

Secondary Outcomes (6)

  • AUC(0-168) of copanlisib after each copanlisib IV infusion during 2 cycles of copanlisib monotherapy

    After day 22

  • AEs as characterized by type, frequency, severity (as graded by CTCAE) and relationship to study drug

    Approximately 2 years

  • Maximum change from baseline in insulin during 2 cycles of copanlisib

    After day 22

  • Maximum change from baseline in C-peptide during 2 cycles of copanlisib

    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

    After day 22

  • +1 more secondary outcomes

Study Arms (2)

Arm 1

EXPERIMENTAL

0.8 mg/kg body weight and 0.4 mg/kg (not to exceed 65 mg) for the non-diabetic patients

Drug: Copanlisib (BAY80-6946)

Arm 2

EXPERIMENTAL

45 mg and 60 mg for the diabetic patients

Drug: Copanlisib (BAY80-6946)

Interventions

Copanlisib (BAY80-6946)DRUG

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.

Arm 1Arm 2

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Previous or concurrent cancer that is distinct in primary site or histology from NHL or the solid tumor, for which the patient is enrolled into this study, within 5 years before treatment start EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer, in situ breast cancer, in situ prostate carcinoma if Gleason score \< or equal to 6 and prostate-specific antigen \<10 ng/mL, and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)\]
  • Known lymphomatous involvement of the brain or leptomeningeal involvement; solid tumor patients with central nervous system (CNS) metastases if treatment completed \<3 months before enrollment or lesions unstable or progressing on magnetic resonance imaging scans performed within 1 month of enrollment or unstable symptoms of the CNS metastases
  • Any illness or medical condition that is unstable or could jeopardize the safety of the patient or his / her compliance in the study
  • Current diagnosis of type 1 or type 2 diabetes mellitus with HbA1c \< or equal to 8.5% or fasting blood glucose \< or equal to 160 mg/dL

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Bruxelles - Brussel, 1000, Belgium

Location

Unknown Facility

Bruxelles - Brussel, 1200, Belgium

Location

Unknown Facility

Ghent, 9000, Belgium

Location

Unknown Facility

Caen, 14076, France

Location

Unknown Facility

Lille, 59037, France

Location

Unknown Facility

Nice, 06102, France

Location

Unknown Facility

Pierre-Bénite, 69495, France

Location

Unknown Facility

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Unknown Facility

London, W1G 6AD, United Kingdom

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

copanlisib

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2014

First Posted

June 4, 2014

Study Start

August 12, 2014

Primary Completion

October 4, 2016

Study Completion

March 16, 2017

Last Updated

June 16, 2017

Record last verified: 2017-06

Locations

BE(3)FR(4)GB(2)