Expanded Access to Provide Copanlisib for Patients With Cancer Who Are Experiencing a Positive Response, as Determined by Their Doctors
Copanlisib Expanded Access Program (EAP) for Patients Who, in the Opinion of Their Healthcare Provider, Are Deriving Benefit From Copanlisib Therapy
1 other identifier
expanded_access
N/A
11 countries
11
Brief 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. 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.
Trial Health
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11 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2024
CompletedFirst Posted
Study publicly available on registry
February 2, 2024
CompletedFebruary 2, 2024
January 1, 2024
January 24, 2024
January 24, 2024
Conditions
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (11)
Many Locations
Multiple Locations, Brazil
Many Locations
Multiple Locations, Chile
Many Locations
Multiple Locations, Hong Kong
Many Locations
Multiple Locations, Hungary
Many Locations
Multiple Locations, Ireland
Many Locations
Multiple Locations, Malaysia
Many Locations
Multiple Locations, Poland
Many Locations
Multiple Locations, Romania
Many Locations
Multiple Locations, Russia
Many Locations
Multiple Locations, Taiwan
Many Locations
Multiple Locations, Ukraine