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

  • Brazil
      • Multiple Locations, Brazil
        • Many Locations
  • Chile
      • Multiple Locations, Chile
        • Many Locations
  • Hong Kong
      • Multiple Locations, Hong Kong
        • Many Locations
  • Hungary
      • Multiple Locations, Hungary
        • Many Locations
  • Ireland
      • Multiple Locations, Ireland
        • Many Locations
  • Malaysia
      • Multiple Locations, Malaysia
        • Many Locations
  • Poland
      • Multiple Locations, Poland
        • Many Locations
  • Romania
      • Multiple Locations, Romania
        • Many Locations
  • Russian Federation
      • Multiple Locations, Russian Federation
        • Many Locations
  • Taiwan
      • Multiple Locations, Taiwan
        • Many Locations
  • Ukraine
      • Multiple Locations, Ukraine
        • Many Locations

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

Bayer

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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