- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06238583
Expanded Access to Provide Copanlisib for Patients With Cancer Who Are Experiencing a Positive Response, as Determined by Their Doctors
January 24, 2024 updated by: Bayer
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.
Study Overview
Status
No longer available
Conditions
Intervention / Treatment
Study Type
Expanded Access
Expanded Access Type
- Intermediate-size Population
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Multiple Locations, Brazil
- Many Locations
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Multiple Locations, Chile
- Many Locations
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Multiple Locations, Hong Kong
- Many Locations
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Multiple Locations, Hungary
- Many Locations
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Multiple Locations, Ireland
- Many Locations
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Multiple Locations, Malaysia
- Many Locations
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Multiple Locations, Poland
- Many Locations
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Multiple Locations, Romania
- Many Locations
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Multiple Locations, Russian Federation
- Many Locations
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Multiple Locations, Taiwan
- Many Locations
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Multiple Locations, Ukraine
- Many Locations
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
January 24, 2024
First Submitted That Met QC Criteria
January 24, 2024
First Posted (Estimated)
February 2, 2024
Study Record Updates
Last Update Posted (Estimated)
February 2, 2024
Last Update Submitted That Met QC Criteria
January 24, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 22702
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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