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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003705-94 | EudraCT Number |
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This open-label, multicenter, 3-period, fixed-sequence study will evaluate the effect of multiple oral doses of vemurafenib on the pharmacokinetics of a single oral dose of tizanidine in participants with BRAFV600 mutation-positive metastatic malignancies. Participants will receive a single oral dose of tizanidine on Day 1, vemurafenib orally twice daily on Days 2 to 21, and tizanidine and vemurafenib on Day 22. Eligible participants will have the option to continue treatment with vemurafenib as part of an extension study (NCT01739764).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacokinetic Population | Experimental | All participants will receive a 3-period treatment including single-dose tizanidine on Day 1, twice-daily vemurafenib on Days 2 to 21, and both agents together on Day 22. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tizanidine | Drug | Participants will receive tizanidine as single oral doses, 2 milligrams (mg) on Day 1 and repeated on Day 22, each following an overnight fast >/= 10 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of tizanidine under conditions of vemurafenib steady-state exposure: Area under the concentration-time curve (AUC) | Pre-dose and up to 12 hours post-dose | |
| Pharmacokinetics of tizanidine under conditions of vemurafenib steady-state exposure: Maximum plasma concentration (Cmax) | Pre-dose and up to 12 hours post-dose | |
| Pharmacokinetics of tizanidine under conditions of vemurafenib steady-state exposure: Time to maximum plasma concentration (Tmax) | Pre-dose and up to 12 hours post-dose | |
| Pharmacokinetics of tizanidine under conditions of vemurafenib steady-state exposure: Terminal half-life (t1/2) | Pre-dose and up to 12 hours post-dose | |
| Pharmacokinetics of tizanidine under conditions of vemurafenib steady-state exposure: Apparent clearance (CL/F) | Pre-dose and up to 12 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence, nature and severity of adverse events and serious adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 | Up to approximately 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diablo Valley Oncology and Hematology | Pleasant Hill | California | 94523 | United States | ||
| Karmanos Cancer Center |
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| Vemurafenib | Drug | Participants will receive vemurafenib as multiple oral doses, 960 mg twice daily on Days 2 to 22. |
|
| Detroit |
| Michigan |
| 48201 |
| United States |
| Duke University Health Systems | Durham | North Carolina | 27710 | United States |
| Instituto Nacional do Cancer - INCA | Rio de Janeiro | Rio de Janeiro | 20560-120 | Brazil |
| Hospital de Caridade de Ijui; Oncologia | Ijuí | Rio Grande do Sul | 98700-000 | Brazil |
| CITO - Centro Integrado de Terapia Onco-Hematológica - Hospital da Cidade de Passo Fundo | Passo Fundo | Rio Grande do Sul | 99010-260 | Brazil |
| Hospital Sao Lucas - PUCRS | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| CSSS champlain - Charles-Le Moyne | Greenfield Park | Quebec | J4V 2H1 | Canada |
| Bank of Cyprus Oncology Center | Nicosia | 2006 | Cyprus |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Asan Medical Center. | Seoul | 138-736 | South Korea |
| 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 |
|---|---|
| C023754 | tizanidine |
| D000077484 | Vemurafenib |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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