Trial Condition(s):

Cancer

Expanded access to provide copanlisib for patients with cancer who are experiencing a positive response, as determined by their doctors

Bayer Identifier:

22702

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study Completed

Trial Purpose

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.

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).

Trial Summary

Enrollment Goal
N/A
Trial Dates
N/A
black-arrow
N/A
Phase
N/A
Could I receive a placebo?
No
Products
Aliqopa (Copanlisib, BAY80-6946)
Accepts Healthy Volunteers
N/A

Where to Participate

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Locations
Locations
Locations

Many Locations

Many Locations, Brazil

Locations

Many Locations

Many Locations, Chile

Locations

Many Locations

Many Locations, Hong Kong, China

Locations

Many Locations

Many Locations, Hungary

Locations

Many Locations

Many Locations, Ireland

Locations

Many Locations

Many Locations, Malaysia

Locations

Many Locations

Many Locations, Poland

Locations

Many Locations

Many Locations, Romania

Locations

Many Locations

Many Locations, Russia

Locations

Many Locations

Many Locations, Taiwan, China

Locations

Many Locations

Many Locations, Ukraine

For details, please refer to trial results

Additional Information

Not Available