Copanlisib Pharmacodynamic Study

Phase 1

Completed

• Conditions: Non Hodgkin Lymphoma
• Interventions: Drug: Copanlisib (BAY80-6946)

• Registration Number: NCT02155582
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-02
• Study First Submitted QC: 2014-06-02
• Study First Posted: 2014-06-04
• Study Start: 2014-08-12
• Primary Completion: 2016-10-04
• Study Completion: 2017-03-16
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-15
• Last Update Posted: 2017-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

Not provided

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Copanlisib (BAY80-6946)	45 mg and 60 mg for the diabetic patients
Arm 1	Copanlisib (BAY80-6946)	0.8 mg/kg body weight and 0.4 mg/kg (not to exceed 65 mg) for the non-diabetic patients

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
AEs as characterized by type, frequency, severity (as graded by CTCAE) and relationship to study drug	Approximately 2 years
Maximum change from baseline in C-peptide during 2 cycles of copanlisib	After day 22
Change from baseline in expression and / or phosphorylation of PI3K pathway proteins in paired tumor biopsies	Baseline and after day 22
AUC(0-168) of copanlisib after each copanlisib IV infusion during 2 cycles of copanlisib monotherapy	After day 22
Maximum change from baseline in insulin 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