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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
Inclusion Criteria:
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.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Multiple Locations | Brazil | ||||
| Many Locations |
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| 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 |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000589253 | copanlisib |
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