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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-006454-10 |
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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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The purpose of the trial is to identify the recommended dose of sorafenib and sirolimus for combination therapy in subsequent phase 2 trials.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorafenib | Drug | |||
| Sirolimus | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| identify the recommended doses for the combination of sorafenib and sirolimus for subsequent phase II studies |
| Measure | Description | Time Frame |
|---|---|---|
| to determine the safety profile of the combination therapy of sorafenib with sirolimus | ||
| to determine, if possible, the Maximum Tolerated Dose (MTD) of sorafenib and sirolimus in combination therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| C.M.L. van Herpen, MD, PhD | UMC St Radboud | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMC St Radboud | Nijmegen | Netherlands |
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| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| D020123 | Sirolimus |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| to analyze pharmacokinetic PK profiles (AUC, Cmax) during combination therapy for sorafenib and sirolimus |
| to evaluate efficacy of the combination descriptively (response rate and rate of stable diseases) |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D018942 | Macrolides |
| D007783 | Lactones |