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The purpose of this study is to determine intratumoral concentration of kinase inhibitors upon 2 weeks of treatment in tumor tissue of patients.
Patients will be cohort-wise treated with clinically available kinase inhibitors for 2 weeks prior to standard palliative treatment. Five patients will be included in each of eight drug cohorts. Biopsies will be performed to determine intratumoral drug concentrations and to compare tissue (phospho)proteomic and kinase activity profiles before and during therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kinase inhibitor | Experimental | Patients are cohort-wise treated with a registered (tyrosine) kinase inhibitor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunitinib | Drug | 50 mg once daily, oral use, 14 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| concentrations of intratumoral kinase inhibitors upon 2 weeks of treatment | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| kinase inhibitor concentrations in plasma, serum and PBMC's upon 2 weeks of treatment | 2 weeks | |
| intra-dermal kinase inhibitor concentrations upon 2 weeks of treatment | 2 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| H.M.W. Verheul, MD, PhD | VU Medical Center Amsterdam | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VUMedical Center | Amsterdam | 1081 HV | Netherlands |
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| Sorafenib |
| Drug |
400 mg, twice daily, oral use, 14 days |
|
| Erlotinib | Drug | 150 mg once daily, oral use, 14 days |
|
| Everolimus | Drug | 10 mg once daily, oral use, 14 days |
|
| Lapatinib | Drug | 1250 mg once daily, oral use, 14 days |
|
| Dasatinib | Drug | 100 mg once daily, oral use, 14 days |
|
| Pazopanib | Drug | 800 mg once daily, oral use, 14 days |
|
| Vemurafenib | Drug | 960 mg twice daily, oral use, 15-21 days |
|
| tumor biopsy | Procedure |
|
| skin biopsy (optional) | Procedure |
|
| To determine per patient whether 2 weeks of treatment with kinase inhibitors induces significant change of phosphoproteomic profiles in tumor tissue |
| 2 weeks |
| To determine per patient whether 2 weeks of treatment with kinase inhibitors induces significant change of kinase activity in tumor tissue | 2 weeks |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| D000077157 | Sorafenib |
| D000069347 | Erlotinib Hydrochloride |
| D000068338 | Everolimus |
| D000077341 | Lapatinib |
| D000069439 | Dasatinib |
| C516667 | pazopanib |
| D000077484 | Vemurafenib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D011725 | Pyridines |
| D011799 | Quinazolines |
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
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