Expanded Access to Provide Copanlisib for Patients With Cancer Who Are Experiencing a Positive Response, as Determined by Their Doctors

Cancer Clinical Trial

Official title:

Copanlisib Expanded Access Program (EAP) for Patients Who, in the Opinion of Their Healthcare Provider, Are Deriving Benefit From Copanlisib Therapy

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT06238583
• Other study ID #: 22702
• Status: No longer available

Study information

• Verified date: January 2024
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical 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. 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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
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
Russian Federation	Many Locations	Multiple Locations
Taiwan	Many Locations	Multiple Locations
Ukraine	Many Locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Brazil,  Chile,  Hong Kong,  Hungary,  Ireland,  Malaysia,  Poland,  Romania,  Russian Federation,  Taiwan,  Ukraine,