Study Completed

Cancer

Bayer Identifier:

22702

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available

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

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.

Key Participants Requirements

Sex

All

Age

NaN - N/A

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

null - Today

Phase

N/A

Could I Receive a placebo

Products

Aliqopa (Copanlisib, BAY80-6946)

Accepts Healthy Volunteer

N/A

Where to participate

Status	Institution	Location
Not yet recruiting	Many Locations	Many Locations, Brazil
Not yet recruiting	Many Locations	Many Locations, Chile
Not yet recruiting	Many Locations	Many Locations, Hong Kong
Not yet recruiting	Many Locations	Many Locations, Hungary
Not yet recruiting	Many Locations	Many Locations, Ireland
Not yet recruiting	Many Locations	Many Locations, Malaysia
Not yet recruiting	Many Locations	Many Locations, Poland
Not yet recruiting	Many Locations	Many Locations, Romania
Not yet recruiting	Many Locations	Many Locations, Russian Federation
Not yet recruiting	Many Locations	Many Locations, Taiwan
Not yet recruiting	Many Locations	Many Locations, Ukraine

Trial design

Copanlisib Expanded Access Program (EAP) for patients who, in the opinion of their healthcare provider, are deriving benefit from copanlisib therapy

Trial Type

Expanded Access

Intervention Type

Drug

Trial Purpose

N/A

Allocation

N/A

Blinding

N/A

Assignment

N/A

Trial Arms

N/A