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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003706-27 | EudraCT Number |
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This open-label, multicenter, 3-period, fixed-sequence study will evaluate the effect of multiple doses of vemurafenib on the pharmacokinetics of a single dose of acenocoumarol in participants with BRAFV600 mutation-positive metastatic malignancies. Participants will receive a single dose of acenocoumarol 4 mg orally on Day 1 and Day 23, vemurafenib 960 mg orally twice daily on Days 4-26. After completion of pharmacokinetic assessments on Day 26, eligible participants will have the option to continue treatment with vemurafenib as part of an extension study (GO28399 [NCT01739764]).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acenocoumarol + Vemurafenib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acenocoumarol | Drug | 4 mg single oral doses on Days 1 and 23 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of single-dose acenocoumarol under conditions of vemurafenib steady-state exposure: Area under the concentration-time curve (AUC) | Pre-dose and up to 72 hours post-dose | |
| Pharmacokinetics of single-dose acenocoumarol under conditions of vemurafenib steady-state exposure: Maximum plasma concentration (Cmax) | Pre-dose and up to 72 hours post-dose | |
| Pharmacokinetics of single-dose acenocoumarol under conditions of vemurafenib steady-state exposure: Time to maximum plasma concentration (Tmax) | Pre-dose and up to 72 hours post-dose | |
| Pharmacokinetics of single-dose acenocoumarol under conditions of vemurafenib steady-state exposure: Terminal half-life (t1/2) | Pre-dose and up to 72 hours post-dose | |
| Pharmacokinetics of single-dose acenocoumarol under conditions of vemurafenib steady-state exposure: Apparent clearance (CL/F) | Pre-dose and up to 72 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of Adverse Events and Serious Adverse Events | approximately 1.5 years |
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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 |
|---|---|---|---|---|---|---|
| Wodonga | New South Wales | 3690 | Australia | |||
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| vemurafenib |
| Drug |
960 mg orally bid, 20 days (Days 4-23) |
|
|
| Buxtehude |
| 21614 |
| Germany |
| Essen | 45122 | Germany |
| Mannheim | 68167 | Germany |
| Crete | 71110 | Greece |
| Thessaloniki | 56429 | Greece |
| Budapest | 1122 | Hungary |
| Amsterdam | 1066 CX | Netherlands |
| Maastricht | 6229HX | Netherlands |
| Utrecht | 3584 CX | Netherlands |
| Auckland | 1142 | New Zealand |
| Christchurch | 8011 | New Zealand |
| Lisbon | 1099-023 | Portugal |
| Porto | 4200-072 | Portugal |
| Belgrade | 11000 | Serbia |
| Barcelona | Barcelona | 08036 | Spain |
| Barcelona | Barcelona | 08908 | Spain |
| Madrid | Madrid | 28031 | Spain |
| Madrid | Madrid | 28040 | Spain |
| Madrid | Madrid | 28050 | Spain |
| 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 |
|---|---|
| D000074 | Acenocoumarol |
| D000077484 | Vemurafenib |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D007211 | Indoles |
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