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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004746-42 | EudraCT Number |
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This study aims to analyze what the study drug does to the body and its relationship to drug levels and safety after patients with advanced cancer have been treated with copanlisib in different dose groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | 0.8 mg/kg body weight and 0.4 mg/kg (not to exceed 65 mg) for the non-diabetic patients |
|
| Arm 2 | Experimental | 45 mg and 60 mg for the diabetic patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Copanlisib (BAY80-6946) | Drug | 0.8 mg/kg body weight and 0.4 mg/kg (not to exceed 65 mg) for the non-diabetic patients;45 mg and 60 mg for the diabetic patients; Intravenous (IV) infusion over 1 hour. Dosing of copanlisib will be on Days 1, 8, and 15 of each 28 day treatment cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum change from baseline in expression of pathway inhibition (pAKT) in surrogate tissue (platelet rich plasma) during copanlisib monotherapy | Baseline and approximately 2 years | |
| Maximum change from baseline in plasma glucose during 2 cycles of copanlisib monotherapy | Baseline and after day 22 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-168) of copanlisib after each copanlisib IV infusion during 2 cycles of copanlisib monotherapy | After day 22 | |
| AEs as characterized by type, frequency, severity (as graded by CTCAE) and relationship to study drug | Approximately 2 years |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bruxelles - Brussel | 1000 | Belgium | ||||
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| C000589253 | copanlisib |
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| Maximum change from baseline in insulin during 2 cycles of copanlisib | After day 22 |
| Maximum change from baseline in C-peptide during 2 cycles of copanlisib | After day 22 |
| FDG PET early response (decreased SUVmax compared to baseline) after dosing with copanlisib for non-diabetic patients with detectable FDG tumor uptake at baseline | After day 22 |
| Change from baseline in expression and / or phosphorylation of PI3K pathway proteins in paired tumor biopsies | Baseline and after day 22 |
| Bruxelles - Brussel |
| 1200 |
| Belgium |
| Ghent | 9000 | Belgium |
| Caen | 14076 | France |
| Lille | 59037 | France |
| Nice | 06102 | France |
| Pierre-Bénite | 69495 | France |
| Sutton | Surrey | SM2 5PT | United Kingdom |
| London | W1G 6AD | United Kingdom |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |