CancerNCT06238583
Expanded Access to Provide Copanlisib for Patients With Cancer Who Are Experiencing a Positive Response, as Determined by Their Doctors
A study testing Copanlisib (Aliqopa, BAY80-6946) in people with Cancer, run by Bayer at 11 sites in 11 countries.
Trial summary
The purpose of this Expanded Access Program (EAP) is to allow patients to continue receiving treatment with copanlisib if they are currently having, in the opinion of their healthcare provider, an objective favorable response when taking copanlisib. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer
- What is being tested?
- Copanlisib (Aliqopa, BAY80-6946)
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 11 sitesin 11 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Patient has provided written informed consent.
- Patient meets one of the following criteria:
- Already enrolled and on treatment with copanlisib in Bayer-sponsored Study 17067 (CHRONOS-3), OR
- Already enrolled and on treatment with copanlisib in an investigator-initiated research (IIR)/institution-sponsored collaborative study (ISCS), OR
- Currently on copanlisib treatment prescribed by a healthcare provider.
- Patient is deriving an objective favorable response from copanlisib in the opinion of their healthcare provider.
- Patient has no suitable alternative treatments available.
- Women of childbearing potential and men must agree to use effective contraception when sexually active due to potential embryo-fetal toxicity for 1 month after the last dose.
Who cannot join
- Patients who may have developed a disease/condition/toxicity that would conflict with continuing to receive copanlisib treatment.
- Patients on treatment with rituximab (R) either alone or in combination with chemotherapy, including an alkylating agent (e.g. bendamustine [R-B] or cyclophosphamide, hydroxydoxorubicin, vincristine, prednisone [R-CHOP]) for relapsed indolent non-Hodgkin's lymphoma (iNHL).
Trial locations and contacts
11 sites in 11 countries.
11 sites in 11 countries
About this study
Official title: Copanlisib Expanded Access Program (EAP) for Patients Who, in the Opinion of Their Healthcare Provider, Are Deriving Benefit From Copanlisib Therapy
The purpose of this Expanded Access Program (EAP) is to allow patients to continue receiving treatment with copanlisib if they are currently having, in the opinion of their healthcare provider, an objective favorable response when taking copanlisib. Patients considering this access program should have no other therapeutic option, have not developed a disease and/or medical condition (including pregnancy), and/or have a toxicity that would conflict with continuing to receive copanlisib.
- Conditions
- Cancer
- Being tested
- Copanlisib (Aliqopa, BAY80-6946)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Copanlisib (Aliqopa, BAY80-6946)Drug
Copanlisib is supplied as lyophilized preparation in a 6 mL injection vial. The total amount of copanlisib per vial is 60 mg. The recommended dose of copanlisib is 60 mg administered as a 1 hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day treatment cycle on an intermittent schedule (3 weeks on and 1 week off), OR at a lower dose if dose reduction has occurred on prior treatment. Patients currently included on study protocols may continue their treatment regimen at the discretion of their healthcare provider.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238583
- Sponsor's protocol ID
- 22702
- Status last verified
- Jan 2024
- First submitted
- 24 Jan 2024
- Last updated
- 2 Feb 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Copanlisib Expanded Access Program (EAP) for Patients Who, in the Opinion of Their Healthcare Provider, Are Deriving Benefit From Copanlisib Therapy
- ClinicalTrials.gov ID
- NCT06238583
- Acronym / sponsor ID
- 22702
- Conditions
- Cancer
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- First posted
- 2 Feb 2024 (actual)
- 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.
The purpose of this Expanded Access Program (EAP) is to allow patients to continue receiving treatment with copanlisib if they are currently having, in the opinion of their healthcare provider, an objective favorable response when taking copanlisib. Patients considering this access program should have no other therapeutic option, have not developed a disease and/or medical condition (including pregnancy), and/or have a toxicity that would conflict with continuing to receive copanlisib.
Study design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patient has provided written informed consent.
- Patient meets one of the following criteria:
- Patient is deriving an objective favorable response from copanlisib in the opinion of their healthcare provider.
- Patient has no suitable alternative treatments available.
- Women of childbearing potential and men must agree to use effective contraception when sexually active due to potential embryo-fetal toxicity for 1 month after the last dose.
Key exclusion criteria (2 listed)
- Patients who may have developed a disease/condition/toxicity that would conflict with continuing to receive copanlisib treatment.
- Patients on treatment with rituximab (R) either alone or in combination with chemotherapy, including an alkylating agent (e.g. bendamustine [R-B] or cyclophosphamide, hydroxydoxorubicin, vincristine, prednisone [R-CHOP]) for relapsed indolent non-Hodgkin's lymphoma (iNHL).
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)Copanlisib is supplied as lyophilized preparation in a 6 mL injection vial. The total amount of copanlisib per vial is 60 mg. The recommended dose of copanlisib is 60 mg administered as a 1 hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day treatment cycle on an intermittent schedule (3 weeks on and 1 week off), OR at a lower dose if dose reduction has occurred on prior treatment. Patients currently included on study protocols may continue their treatment regimen at the discretion of their healthcare provider. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Copanlisib (Aliqopa, BAY80-6946) in people with Cancer, run by Bayer at 11 sites in 11 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 8 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Brazil, Chile, Hong Kong, Hungary, Ireland and 6 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.
Are results available for this study?
Results are not available in the source record.
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.
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 2 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.