Non Hodgkin LymphomaPhase 1NCT02155582
Copanlisib Pharmacodynamic Study
A Phase 1 study testing Copanlisib (BAY80-6946) in people with Non Hodgkin Lymphoma, run by Bayer at 9 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Non Hodgkin Lymphoma
- What is being tested?
- Copanlisib (BAY80-6946)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 12 Aug 2014to 16 Mar 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
France4 sites
Study site
Caen, 14076
Study site
Lille, 59037
Study site
Nice, 06102
Study site
Pierre-Bénite, 69495
Belgium3 sites
Study site
Bruxelles - Brussel, 1000
Study site
Bruxelles - Brussel, 1200
Study site
Ghent, 9000
United Kingdom2 sites
Study site
London, W1G 6AD
Study site
Sutton, Surrey, SM2 5PT
About this study
Official title: A Phase I Pharmacodynamic Study of Copanlisib (BAY 80-6946) as Monotherapy in Patients With Non-Hodgkin's Lymphoma and Solid Tumors
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.
- Conditions
- Non Hodgkin Lymphoma
- Being tested
- Copanlisib (BAY80-6946)
- Keywords
- Solid tumors
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | 0.8 mg/kg body weight and 0.4 mg/kg (not to exceed 65 mg) for the non-diabetic patients Receives: Drug: Copanlisib (BAY80-6946) |
| Arm 2 | Experimental | 45 mg and 60 mg for the diabetic patients Receives: Drug: Copanlisib (BAY80-6946) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum change from baseline in expression of pathway inhibition (pAKT) in surrogate tissue (platelet rich plasma) during copanlisib monotherapy
Measured: Baseline and approximately 2 years
Maximum change from baseline in plasma glucose during 2 cycles of copanlisib monotherapy
Measured: Baseline and after day 22
Secondary outcomes (6)
AUC(0-168) of copanlisib after each copanlisib IV infusion during 2 cycles of copanlisib monotherapy
Measured: After day 22
AEs as characterized by type, frequency, severity (as graded by CTCAE) and relationship to study drug
Measured: Approximately 2 years
Maximum change from baseline in insulin during 2 cycles of copanlisib
Measured: After day 22
Maximum change from baseline in C-peptide during 2 cycles of copanlisib
Measured: 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
Measured: After day 22
Change from baseline in expression and / or phosphorylation of PI3K pathway proteins in paired tumor biopsies
Measured: Baseline and after day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2014 (estimated)
- Study start12 Aug 2014
- Primary completion4 Oct 2016
- Study completion16 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Hodgkin 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 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
- NCT02155582
- Sponsor's protocol ID
- 16790
- Other IDs
- 2013-004746-42
- Status last verified
- Jun 2017
- First submitted
- 2 Jun 2014
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Pharmacodynamic Study of Copanlisib (BAY 80-6946) as Monotherapy in Patients With Non-Hodgkin's Lymphoma and Solid Tumors
- ClinicalTrials.gov ID
- NCT02155582
- Acronym / sponsor ID
- 16790
- Conditions
- Non Hodgkin Lymphoma
- Keywords
- Solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2014 (actual)
- Primary completion
- 4 Oct 2016 (actual)
- Study completion
- 16 Mar 2017 (actual)
- First posted
- 4 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Copanlisib (BAY80-6946)0.8 mg/kg body weight and 0.4 mg/kg (not to exceed 65 mg) for the non-diabetic patients |
| Arm 2 | Experimental | Drug: Copanlisib (BAY80-6946)45 mg and 60 mg for the diabetic patients |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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
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 (BAY80-6946)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. | Drug | Arm 1, Arm 2 |
Primary outcome
Maximum change from baseline in expression of pathway inhibition (pAKT) in surrogate tissue (platelet rich plasma) during copanlisib monotherapy
Time frame: Baseline and approximately 2 years
Maximum change from baseline in plasma glucose during 2 cycles of copanlisib monotherapy
Time frame: Baseline and after day 22
6 secondary outcomes
AUC(0-168) of copanlisib after each copanlisib IV infusion during 2 cycles of copanlisib monotherapy
Time frame: After day 22
AEs as characterized by type, frequency, severity (as graded by CTCAE) and relationship to study drug
Time frame: Approximately 2 years
Maximum change from baseline in insulin during 2 cycles of copanlisib
Time frame: After day 22
Maximum change from baseline in C-peptide during 2 cycles of copanlisib
Time frame: 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
Time frame: After day 22
Change from baseline in expression and / or phosphorylation of PI3K pathway proteins in paired tumor biopsies
Time frame: Baseline and after day 22
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
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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
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Copanlisib (BAY80-6946) in people with Non Hodgkin Lymphoma, run by Bayer at 9 sites in 3 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 0 inclusion and 4 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 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France, Belgium, United Kingdom. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum change from baseline in expression of pathway inhibition (pAKT) in surrogate tissue (platelet rich plasma) during copanlisib monotherapy (time frame: Baseline and approximately 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jun 2017.