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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-001631-36 | EudraCT Number | EudraCT |
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The main objective of this trial is to provide safety data in terms of drug-related adverse events for the recommendation of the dose for further trials in the development of BI 831266.
Secondary objectives are the collection of antitumour efficacy data and the determination of the pharmacokinetic and pharmacodynamic profile of BI 831266.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | BI 831266 24h infusion on day 1 and day 15 every 4 weeks |
|
| Arm B | Experimental | BI 831266 24h infusion on day 1 every 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arm A | Drug | Dose escalation Arm A (4 weeks) |
| |
| Arm B |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose | 3-4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety parameters (incidence and intensity of AEs graded according to the common terminology criteria for AEs and incidence of DLT) | throughout the study period | |
| Pharmacokinetic parameters | throughout the study period |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1257.1.4303 Boehringer Ingelheim Investigational Site | Linz | Austria | ||||
| 1257.1.4302 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25529193 | Derived | Dittrich C, Fridrik MA, Koenigsberg R, Lee C, Goeldner RG, Hilbert J, Greil R. A phase 1 dose escalation study of BI 831266, an inhibitor of Aurora kinase B, in patients with advanced solid tumors. Invest New Drugs. 2015 Apr;33(2):409-22. doi: 10.1007/s10637-014-0201-7. Epub 2014 Dec 23. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Drug |
Dose escalation Arm B (3 weeks) |
|
| Pharmacodynamic analysis | 3-4 weeks |
| Efficacy data (progression free survival, objective response rate, response duration) | throughout the study period |
| Salzburg |
| Austria |
| 1257.1.4301 Boehringer Ingelheim Investigational Site | Vienna | Austria |