Diffuse, Large B-Cell, LymphomaPhase 2NCT02391116
Phase II Copanlisib in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)
A Phase 2 study testing Copanlisib (Aliqopa, BAY80-6946) in people with Diffuse, Large B-Cell, Lymphoma, run by Bayer at 32 sites in 10 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse, Large B-Cell, Lymphoma
- What is being tested?
- Copanlisib (Aliqopa, BAY80-6946)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 32 sitesin 10 countries
- Study dates
- 8 May 2015to 19 Jan 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
32 sites in 10 countries.
32 sites in 10 countries
France6 sites
Study site
Caen, 14033
Study site
Créteil, 94010
Study site
Lille, 59037
Study site
Paris, 75475
Study site
Pierre-Bénite, 69310
Study site
Poitiers, 86021
Belgium5 sites
Study site
Bruxelles - Brussel, 1200
Study site
Edegem, 2650
Study site
Ghent, 9000
Study site
Leuven, 3000
Study site
Wilrijk, Antwerpen, 2610
Canada5 sites
Study site
Brampton, Ontario, L6R 3J7
Study site
Montreal, Quebec, H1T 2M4
Study site
Montreal, Quebec, H3T 1E2
Study site
Sherbrooke, Quebec, J1H 5N4
Study site
St. John's, Newfoundland and Labrador, A1B 3V6
Australia4 sites
Study site
Ballarat, Victoria, 3350
Study site
Box Hill, 3128
Study site
Kingswood, New South Wales, 2747
Study site
Prahran, Victoria, 3181
Germany3 sites
Study site
Berlin, 10967
Study site
Leipzig, Saxony
Study site
Münster, North Rhine-Westphalia, 48149
United Kingdom3 sites
Study site
London, NW1 2PG
Study site
Southampton, Hampshire, SO16 6YD
Study site
Truro, Cornwall, TR1 3LJ
About this study
Official 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.
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
- Conditions
- Diffuse, Large B-Cell, Lymphoma
- Being tested
- Copanlisib (Aliqopa, BAY80-6946)
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Copanlisib (Aliqopa, BAY80-6946)Drug
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
| Study group | Role | What they receive |
|---|---|---|
| Copanlisib (Aliqopa, BAY80-6946) | Experimental | Copanlisib (Aliqopa, BAY80-6946) solution for IV infusion (test drug/investigational medicinal product) Receives: Drug: Copanlisib (Aliqopa, BAY80-6946) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) in Total Population Based on Investigator Assessment
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.
Measured: 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)
ORR by CD79b Status Based on Investigator Assessment
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.
Measured: 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)
ORR by DLBCL/COO Subtype Based on Investigator Assessment
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.
Measured: 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 outcomes (14)
Duration of Response (DOR) in Total Population
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.
Measured: 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
DOR by CD79b Status
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.
Measured: 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
DOR by DLBCL/COO Subtype
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.
Measured: 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
Progression-free Survival (PFS) in Total Population
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.
Measured: 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
PFS by CD79b Status
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.
Measured: 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
PFS by DLBCL/COO Subtype
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.
Measured: 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
Overall Survival (OS) in Total Population
The overall survival (OS) was defined as the time from date of start of study treatment until death from any cause.
Measured: 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
OS by CD79b Status
The overall survival (OS) was defined as the time from date of start of study treatment until death from any cause.
Measured: 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
OS by DLBCL/COO Subtype
The overall survival (OS) was defined as the time from date of start of study treatment until death from any cause.
Measured: 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
Duration of Stable Disease (DOSD) in Total Population
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.
Measured: 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
Disease Control Rate (DCR) in Total Population
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.
Measured: 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
DCR by CD79b Status
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.
Measured: 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
DCR by DLBCL/COO Subtype
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.
Measured: 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
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
A TEAE was defined as any event arising or worsening after the start of study drug administration until 30 days after the last application.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study start8 May 2015
- Primary completion5 Jul 2016
- Study completion19 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diffuse, Large B-Cell, LymphomaStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02391116
- Sponsor's protocol ID
- 17119
- Other IDs
- 2014-004848-36, 2014
- Status last verified
- Dec 2018
- First submitted
- 16 Feb 2015
- Last updated
- 4 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Lenz G, Hawkes E, Verhoef G, Haioun C, Thye Lim S, Seog Heo D, Ardeshna K, Chong G, Haaber J, Shi W, Gorbatchevsky I, Lippert S, Hiemeyer F, Piraino P, Beckmann G, Pena C, Buvaylo V, Childs BH, Salles G. Single-agent activity of phosphatidylinositol 3-kinase inhibition with copanlisib in patients with molecularly defined relapsed or refractory diffuse large B-cell lymphoma. Leukemia. 2020 Aug;34(8):2184-2197. doi: 10.1038/s41375-020-0743-y. Epub 2020 Feb 14.
PubMed 32060403
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT02391116
- Acronym / sponsor ID
- 17119
- Conditions
- Diffuse, Large B-Cell, Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 8 May 2015 (actual)
- Primary completion
- 5 Jul 2016 (actual)
- Study completion
- 19 Jan 2018 (actual)
- First posted
- 18 Mar 2015 (estimated)
- Results
- Posted 8 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Copanlisib (Aliqopa, BAY80-6946) | Experimental | Drug: Copanlisib (Aliqopa, BAY80-6946)Copanlisib (Aliqopa, BAY80-6946) solution for IV infusion (test drug/investigational medicinal product) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Copanlisib (Aliqopa, BAY80-6946) |
Primary outcome
Objective Response Rate (ORR) in Total Population Based on Investigator Assessment
Time frame: 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)
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.
ORR by CD79b Status Based on Investigator Assessment
Time frame: 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)
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.
ORR by DLBCL/COO Subtype Based on Investigator Assessment
Time frame: 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)
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.
14 secondary outcomes
Duration of Response (DOR) in Total Population
Time frame: 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
DOR by CD79b Status
Time frame: 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
DOR by DLBCL/COO Subtype
Time frame: 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
Progression-free Survival (PFS) in Total Population
Time frame: 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
PFS by CD79b Status
Time frame: 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
PFS by DLBCL/COO Subtype
Time frame: 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
Overall Survival (OS) in Total Population
Time frame: 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
OS by CD79b Status
Time frame: 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
OS by DLBCL/COO Subtype
Time frame: 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
Duration of Stable Disease (DOSD) in Total Population
Time frame: 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
Disease Control Rate (DCR) in Total Population
Time frame: 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
DCR by CD79b Status
Time frame: 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
DCR by DLBCL/COO Subtype
Time frame: 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
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32060403Lenz G, Hawkes E, Verhoef G, Haioun C, Thye Lim S, Seog Heo D, Ardeshna K, Chong G, Haaber J, Shi W, Gorbatchevsky I, Lippert S, Hiemeyer F, Piraino P, Beckmann G, Pena C, Buvaylo V, Childs BH, Salles G. Single-agent activity of phosphatidylinositol 3-kinase inhibition with copanlisib in patients with molecularly defined relapsed or refractory diffuse large B-cell lymphoma. Leukemia. 2020 Aug;34(8):2184-2197. doi: 10.1038/s41375-020-0743-y. Epub 2020 Feb 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
32 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Copanlisib (Aliqopa, BAY80-6946) in people with Diffuse, Large B-Cell, Lymphoma, run by Bayer at 32 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in France, Belgium, Canada, Australia, Germany and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) in Total Population Based on Investigator Assessment (time frame: 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02391116, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2019.