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Primary: Maximum tolerated dose (MTD) Secondary: Determination of the pharmacokinetic profile of BI 2536. Assessment of safety and efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 2536 | Experimental | single escalating dose, followed by repeated administration in patients with clinical benefit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 2536 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determination of the maximum tolerated dose (MTD) by occurrence of dose limiting toxicities (DLT) | up to 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with drug-related adverse events | according to common terminology criteria for adverse events (CTCAE) 3.0 | up to 24 days after last drug administration |
| Number of patients with abnormal laboratory findings |
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Inclusion criteria:
Exclusion Criteria:
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Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
For study documents - upon signing of a "Document Sharing Agreement". For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C518477 | BI 2536 |
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| up to 24 days after last drug administration |
| Change in Eastern Cooperative Oncology Group (ECOG) performance score | baseline, up to 24 days after last drug administration |
| Number of patients with clinically significant changes in vital signs | up to 24 days after last drug administration |
| Number of patients with objective tumor response | up to 24 days after last drug administration |
| Cmax (maximum concentration of the analyte in plasma) | up to 264 hours after drug administration |
| tmax (time from dosing to maximum concentration) | up to 264 hours after drug administration |
| AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | up to 264 hours after drug administration |
| %AUC0-tz (the percentage of the AUC0-∞ that is obtained by extrapolation) | up to 264 hours after drug administration |
| λz (terminal rate constant in plasma) | up to 264 hours after drug administration |
| t1/2 (terminal half-life of the analyte in plasma) | up to 264 hours after drug administration |
| MRT (mean residence time of the analyte in the body after intravenous administration) | up to 264 hours after drug administration |
| CL (total clearance of the analyte in the plasma after intravascular administration) | up to 264 hours after drug administration |
| Vz (apparent volume of distribution during the terminal phase λz following an intravascular dose) | up to 264 hours after drug administration |
| Vss (apparent volume of distribution at steady state following intravascular administration) | up to 264 hours after drug administration |