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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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)
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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.
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Secondary ID [1]
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2014-004848-36
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Secondary ID [2]
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17119
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diffuse, Large B-Cell, Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Objective Response Rate (ORR) in Total Population Based on Investigator Assessment
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Assessment method [1]
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The objective response rate (ORR) was defined as the percentage of participants who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The primary efficacy overall response assessment was based on investigator assessment of response.
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Timepoint [1]
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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)
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Primary outcome [2]
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ORR by CD79b Status Based on Investigator Assessment
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Assessment method [2]
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The objective response rate (ORR) was defined as the percentage of participants who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The primary efficacy overall response assessment was based on investigator assessment of response.
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Timepoint [2]
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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)
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Primary outcome [3]
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ORR by DLBCL/COO Subtype Based on Investigator Assessment
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Assessment method [3]
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The objective response rate (ORR) was defined as the percentage of participants who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The primary efficacy overall response assessment was based on investigator assessment of response.
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Timepoint [3]
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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)
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Secondary outcome [1]
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Duration of Response (DOR) in Total Population
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Assessment method [1]
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The duration of response (DOR) was defined as the time from the date of first observed overall response (CR or PR) until radiological PD or death due to any cause, whichever was earlier. DOR was defined for responders only (i.e. participants with a best response of CR or PR), based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
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Timepoint [1]
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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
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Secondary outcome [2]
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DOR by CD79b Status
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Assessment method [2]
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The duration of response (DOR) was defined as the time from the date of first observed overall response (CR or PR) until radiological PD or death due to any cause, whichever was earlier. DOR was defined for responders only (i.e. participants with a best response of CR or PR), based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
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Timepoint [2]
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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
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Secondary outcome [3]
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DOR by DLBCL/COO Subtype
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Assessment method [3]
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The duration of response (DOR) was defined as the time from the date of first observed overall response (CR or PR) until radiological PD or death due to any cause, whichever was earlier. DOR was defined for responders only (i.e. participants with a best response of CR or PR), based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
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Timepoint [3]
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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
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Secondary outcome [4]
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Progression-free Survival (PFS) in Total Population
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Assessment method [4]
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The progression-free survival (PFS) was defined as the time from date of start of study treatment to radiological PD or death due to any cause, whichever was earlier, based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
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Timepoint [4]
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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
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Secondary outcome [5]
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PFS by CD79b Status
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Assessment method [5]
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The progression-free survival (PFS) was defined as the time from date of start of study treatment to radiological PD or death due to any cause, whichever was earlier, based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
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Timepoint [5]
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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
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Secondary outcome [6]
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PFS by DLBCL/COO Subtype
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Assessment method [6]
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The progression-free survival (PFS) was defined as the time from date of start of study treatment to radiological PD or death due to any cause, whichever was earlier, based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
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Timepoint [6]
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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
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Secondary outcome [7]
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Overall Survival (OS) in Total Population
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Assessment method [7]
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The overall survival (OS) was defined as the time from date of start of study treatment until death from any cause.
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Timepoint [7]
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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
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Secondary outcome [8]
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OS by CD79b Status
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Assessment method [8]
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The overall survival (OS) was defined as the time from date of start of study treatment until death from any cause.
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Timepoint [8]
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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
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Secondary outcome [9]
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OS by DLBCL/COO Subtype
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Assessment method [9]
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The overall survival (OS) was defined as the time from date of start of study treatment until death from any cause.
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Timepoint [9]
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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
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Secondary outcome [10]
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Duration of Stable Disease (DOSD) in Total Population
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Assessment method [10]
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The duration of stable disease (DOSD) was defined as the time (in days) from date of start of study treatment to radiological PD or death due to any cause, whichever was earlier. The DOSD was only evaluated in participants failing to achieve a best response of CR or PR, but who achieved SD (stable disease), based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
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Timepoint [10]
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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
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Secondary outcome [11]
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Disease Control Rate (DCR) in Total Population
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Assessment method [11]
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The disease control rate (DCR) was defined as the percentage of participants who had a best response rating of CR, PR, or SD that was achieved during treatment or within 30 days after termination of study drug. The tumor response was based on investigator assessment according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
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Timepoint [11]
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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
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Secondary outcome [12]
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DCR by CD79b Status
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Assessment method [12]
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The disease control rate (DCR) was defined as the percentage of participants who had a best response rating of CR, PR, or SD that was achieved during treatment or within 30 days after termination of study drug. The tumor response was based on investigator assessment according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
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Timepoint [12]
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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
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Secondary outcome [13]
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DCR by DLBCL/COO Subtype
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Assessment method [13]
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The disease control rate (DCR) was defined as the percentage of participants who had a best response rating of CR, PR, or SD that was achieved during treatment or within 30 days after termination of study drug. The tumor response was based on investigator assessment according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
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Timepoint [13]
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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
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Secondary outcome [14]
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Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
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Assessment method [14]
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A TEAE was defined as any event arising or worsening after the start of study drug administration until 30 days after the last application.
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Timepoint [14]
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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
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/05/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
19/01/2018
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Sample size
Target
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Accrual to date
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Final
67
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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- Kingswood
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Recruitment hospital [2]
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- Ballarat
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Recruitment hospital [3]
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- Prahran
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Recruitment hospital [4]
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- Box Hill
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Recruitment postcode(s) [1]
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2747 - Kingswood
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Recruitment postcode(s) [2]
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3350 - Ballarat
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Recruitment postcode(s) [3]
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3181 - Prahran
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Recruitment postcode(s) [4]
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3128 - Box Hill
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Recruitment outside Australia
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Belgium
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State/province [1]
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Antwerpen
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Belgium
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Bruxelles - Brussel
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Belgium
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State/province [3]
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Edegem
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Belgium
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Gent
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Belgium
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Leuven
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Canada
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Newfoundland and Labrador
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Canada
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State/province [7]
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Ontario
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Canada
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Quebec
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Denmark
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Aarhus C
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Denmark
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Odense C
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France
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Caen Cedex
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France
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Creteil
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France
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Lille
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France
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PARIS cedex
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France
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Pierre Benite
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France
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POITIERS cedex
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Germany
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Nordrhein-Westfalen
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Germany
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Sachsen
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Germany
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Berlin
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Italy
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Lombardia
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Korea, Republic of
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Seoul
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Singapore
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Singapore
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United Kingdom
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Cornwall
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United Kingdom
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State/province [24]
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Hampshire
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bayer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
To assess the potential efficacy (in terms of objective response) of single agent copanlisib
in patients with relapsed or refractory Diffuse large B-cell lymphoma (DLBCL) and assess the
relationship between efficacy and a potentially predictive biomarker
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02391116
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bayer Study Director
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Address
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Bayer
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02391116
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