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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003143-29 | EudraCT Number |
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This open-label, multi-center, three-period, one sequence study will investigate the effect of ketoconazole on the pharmacokinetics of vemurafenib in patients with unresectable BRAFV600-mutation positive metastatic melanoma or other malignant tumor type that harbors a V600-activating mutation of BRAF without acceptable standard treatment options. Patients will receive a single dose of vemurafenib in Periods A and C and multiple doses of ketoconazole in Periods B and C. Eligible patients will have the option to continue treatment with vemurafenib as part of an extension study (NCT01739764). The anticipated time on study treatment is approximately 19 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketoconazole treatment | Experimental |
| |
| Vemurafenib treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ketoconazole | Drug | multiple doses of ketoconazole in Period B and C |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area under the concentration time curve | Approximately 19 days | |
| Pharmacokinetics: Maximum plasma concentration | Approximately 19 days | |
| Pharmacokinetics: Time to maximum plasma concentration | Approximately 19 days | |
| Pharmacokinetics: Terminal half-life | Approximately 19 days | |
| Pharmacokinetics: Apparent clearance | Approximately 19 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | Approximately 19 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
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| vemurafenib |
| Drug |
single dose of vemurafenib in Period A and C |
|
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D007654 | Ketoconazole |
| D000077484 | Vemurafenib |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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