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The purpose of this study is to determine the safety, tolerability and the pharmacokinetics of BAY1082439
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY1082439 | Drug | BAY1082439 will be given orally once daily with a 21 days cycle. Dose will be started from 15mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as a measure of safety and tolerability | Up to 2 years | |
| Maximum tolerated dose of BAY1082439 | Up to 1 year | |
| Maximum observed plasma concentration (Cmax) of BAY1082439 after a single dose | Serial PK samples will be selected during cycle 1 day 1 (pre-dose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose) and sparse samples during the rest of the cycle as well as in cycle 2 | |
| Time to Cmax (tmax) of BAY1082439 after a single dose | Serial PK samples will be selected during cycle 1 day 1 (pre-dose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose) and sparse samples during the rest of the cycle as well as in cycle 2 | |
| Area under the plasma concentration-time curve (AUC[0-t]) of BAY1082439 after a single dose | Serial PK samples will be selected during cycle 1 day 1 (pre-dose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose) and sparse samples during the rest of the cycle as well as in cycle 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve over the dosing interval (AUC[0-tau]) | PK parameters following single and repeat-dose administration in cycle 1 | |
| Maximum observed concentration (Cmax) | PK parameters following single and repeat-dose administration in cycle 1 |
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Inclusion Criteria:
Subjects with advanced, histologically or cytologically confirmed solid tumors, refractory to any standard therapy, have no standard therapy available, or subjects must have actively refused any treatment which would be regarded standard, and / or if in the judgment of the investigator, experimental treatment is clinically and ethically acceptable
International normalized ratio (INR) and partial thromboplastin time (PTT) <1.5 x ULN [Subjects on anticoagulation with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.] For subjects on warfarin, close monitoring of at least weekly evaluations will be performed until INR is stable based on a measurement at pre-dose, as defined by the local standard of care
Measurable or evaluable disease
Life expectancy of at least 12 weeks
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Adequate bone marrow, liver and renal function
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Singapore | 119228 | Singapore | ||||
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Time of occurrence of Cmax (tmax) | PK parameters following single and repeat-dose administration in cycle 1 |
| Terminal phase half-life (t1/2) | PK parameters following single and repeat-dose administration in cycle 1 |
| Tumor response based on Response Evaluation Criteria in Solid Tumors, Version 1.1 | Up to 2 years |
| Singapore |
| 169610 |
| Singapore |
| Seoul | 03080 | South Korea |
| Seoul | 120-752 | South Korea |
| Taipei | 10002 | Taiwan |