Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02391116




Registration number
NCT02391116
Ethics application status
Date submitted
16/02/2015
Date registered
18/03/2015
Date last updated
4/01/2019

Titles & IDs
Public title
Phase II Copanlisib in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Scientific title
An Open-label, Single-arm Phase II Study in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) to Evaluate Efficacy and Safety of Treatment With Single Agent Copanlisib and the Impact of Biomarkers Thereupon.
Secondary ID [1] 0 0
2014-004848-36
Secondary ID [2] 0 0
17119
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diffuse, Large B-Cell, Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Copanlisib (Aliqopa, BAY80-6946)

Experimental: Copanlisib (Aliqopa, BAY80-6946) - Copanlisib (Aliqopa, BAY80-6946) solution for IV infusion (test drug/investigational medicinal product)


Treatment: Drugs: Copanlisib (Aliqopa, BAY80-6946)
Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR) in Total Population Based on Investigator Assessment
Timepoint [1] 0 0
From start of study treatment assessed up to 24 weeks after the last participant fully evaluable for the primary endpoint started treatment (about 12 months)
Primary outcome [2] 0 0
ORR by CD79b Status Based on Investigator Assessment
Timepoint [2] 0 0
From start of study treatment assessed up to 24 weeks after the last participant fully evaluable for the primary endpoint started treatment (about 12 months)
Primary outcome [3] 0 0
ORR by DLBCL/COO Subtype Based on Investigator Assessment
Timepoint [3] 0 0
From start of study treatment assessed up to 24 weeks after the last participant fully evaluable for the primary endpoint started treatment (about 12 months)
Secondary outcome [1] 0 0
Duration of Response (DOR) in Total Population
Timepoint [1] 0 0
From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first
Secondary outcome [2] 0 0
DOR by CD79b Status
Timepoint [2] 0 0
From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first
Secondary outcome [3] 0 0
DOR by DLBCL/COO Subtype
Timepoint [3] 0 0
From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first
Secondary outcome [4] 0 0
Progression-free Survival (PFS) in Total Population
Timepoint [4] 0 0
From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first
Secondary outcome [5] 0 0
PFS by CD79b Status
Timepoint [5] 0 0
From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first
Secondary outcome [6] 0 0
PFS by DLBCL/COO Subtype
Timepoint [6] 0 0
From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first
Secondary outcome [7] 0 0
Overall Survival (OS) in Total Population
Timepoint [7] 0 0
From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first
Secondary outcome [8] 0 0
OS by CD79b Status
Timepoint [8] 0 0
From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first
Secondary outcome [9] 0 0
OS by DLBCL/COO Subtype
Timepoint [9] 0 0
From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first
Secondary outcome [10] 0 0
Duration of Stable Disease (DOSD) in Total Population
Timepoint [10] 0 0
From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first
Secondary outcome [11] 0 0
Disease Control Rate (DCR) in Total Population
Timepoint [11] 0 0
From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first
Secondary outcome [12] 0 0
DCR by CD79b Status
Timepoint [12] 0 0
From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first
Secondary outcome [13] 0 0
DCR by DLBCL/COO Subtype
Timepoint [13] 0 0
From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first
Secondary outcome [14] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Timepoint [14] 0 0
From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant

Eligibility
Key inclusion criteria
* Diagnosis of Diffuse large B-cell lymphoma (DLBCL) (de novo or DLBCL transformed from follicular lymphoma on the basis of a tissue biopsy).
* Received at least one prior therapy for aggressive Non-Hodgkin's Lymphoma (NHL) (DLBCL).
* Received CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) + rituximab or equivalent regimen.
* Patients must have measurable disease.
* Not eligible or not willing to receive the high-dose (myeloablative) chemotherapy (HDC) and stem cell transplant (SCT).
* A fresh tumor biopsy collected during screening and /or archival tumor tissue collected after the last relapse/disease progression.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 2.
* Left ventricular ejection fraction (LVEF) = the lower limit of normal (LLN) for the Institution. (as per local standard of care) as measured by echocardiogram (ECHO) or Multiple gated acquisition (MUGA) scan.
* Adequate bone marrow, liver and renal function.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any of the following as the only site(s) of disease: palpable lymph nodes not visible on imaging studies, skin lesions, or bone marrow involvement only.
* Active CTCAE (Common Terminology Criteria for Adverse Events) Grade 3/4 infection.
* Current central nervous system (CNS) involvement by lymphoma.
* Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months). Myocardial infarction within the past 6 months before start of study treatment.
* Uncontrolled arterial hypertension despite optimal medical management (per investigator's opinion).
* Type I or II diabetes mellitus with HbA1c > 8.5% at Screening.
* New York Heart Association (NYHA) class III or IV heart disease.
* History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function (as judged by the investigator).
* Patients who previously received therapy with copanlisib or other PI3K inhibitors are not eligible for enrollment.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/05/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/01/2018
Sample size
Target
Accrual to date
Final
67
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
- Kingswood
Recruitment hospital [2] 0 0
- Ballarat
Recruitment hospital [3] 0 0
- Prahran
Recruitment hospital [4] 0 0
- Box Hill
Recruitment postcode(s) [1] 0 0
2747 - Kingswood
Recruitment postcode(s) [2] 0 0
3350 - Ballarat
Recruitment postcode(s) [3] 0 0
3181 - Prahran
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Antwerpen
Country [2] 0 0
Belgium
State/province [2] 0 0
Bruxelles - Brussel
Country [3] 0 0
Belgium
State/province [3] 0 0
Edegem
Country [4] 0 0
Belgium
State/province [4] 0 0
Gent
Country [5] 0 0
Belgium
State/province [5] 0 0
Leuven
Country [6] 0 0
Canada
State/province [6] 0 0
Newfoundland and Labrador
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Canada
State/province [8] 0 0
Quebec
Country [9] 0 0
Denmark
State/province [9] 0 0
Aarhus C
Country [10] 0 0
Denmark
State/province [10] 0 0
Odense C
Country [11] 0 0
France
State/province [11] 0 0
Caen Cedex
Country [12] 0 0
France
State/province [12] 0 0
Creteil
Country [13] 0 0
France
State/province [13] 0 0
Lille
Country [14] 0 0
France
State/province [14] 0 0
PARIS cedex
Country [15] 0 0
France
State/province [15] 0 0
Pierre Benite
Country [16] 0 0
France
State/province [16] 0 0
POITIERS cedex
Country [17] 0 0
Germany
State/province [17] 0 0
Nordrhein-Westfalen
Country [18] 0 0
Germany
State/province [18] 0 0
Sachsen
Country [19] 0 0
Germany
State/province [19] 0 0
Berlin
Country [20] 0 0
Italy
State/province [20] 0 0
Lombardia
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Seoul
Country [22] 0 0
Singapore
State/province [22] 0 0
Singapore
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Cornwall
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Hampshire
Country [25] 0 0
United Kingdom
State/province [25] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02391116