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The purpose of this study is to determine the tolerability, maximum tolerated dose and pharmacokinetics of this drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Copanlisib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Copanlisib (Aliqopa, BAY80-6946) | Drug | BAY80-6946 given IV over 1 hour every week for three weeks with a one week break until progression or unacceptable toxicities develop. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Characterize safety, tolerability + pharmacokinetics, to determine the maximum tolerated dose of BAY80-6946 administered 1x weekly for 3 weeks, every 4weeks, as a 1h-intravenous infusion. Evaluate biomarkers that may be predictive of tumor response. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the effects of BAY80-6946 on blood glucose and insulin, and its safety in patients with type I or II diabetes. | 2 years | |
| Evaluate for early signs of efficacy in expansion cohorts | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale | Arizona | 85258 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | A. Patnaik et al. Supplementary materials /Supplementary methods. Annals of Oncology 2016 | ||
| 5035790 | Result | Rowe EL. Automated drop volume apparatus for surface tension measurement. J Pharm Sci. 1972 May;61(5):781-2. doi: 10.1002/jps.2600610523. No abstract available. | |
| 27672108 |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000589253 | copanlisib |
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| Pittsburgh |
| Pennsylvania |
| 15213 |
| United States |
| San Antonio | Texas | 78229-3307 | United States |
| Derived |
| Patnaik A, Appleman LJ, Tolcher AW, Papadopoulos KP, Beeram M, Rasco DW, Weiss GJ, Sachdev JC, Chadha M, Fulk M, Ejadi S, Mountz JM, Lotze MT, Toledo FG, Chu E, Jeffers M, Pena C, Xia C, Reif S, Genvresse I, Ramanathan RK. First-in-human phase I study of copanlisib (BAY 80-6946), an intravenous pan-class I phosphatidylinositol 3-kinase inhibitor, in patients with advanced solid tumors and non-Hodgkin's lymphomas. Ann Oncol. 2016 Oct;27(10):1928-40. doi: 10.1093/annonc/mdw282. |