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This open-label, single-arm, multicenter study will assess the safety and efficacy of Zelboraf (vemurafenib) in patients with Braf V600 mutation positive metastatic melanoma. Patients will receive Zelboraf 960 mg twice a day until progressive disease, unacceptable toxicity, consent withdrawal, death, reasons deemed by the treating physician or study termination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zelboraf Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zelboraf | Drug | Vemurafenib 960 mg twice a day until progressive disease, unacceptable toxicity, consent withdrawal, death, reasons deemed by the treating physician or study termination. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate according to Response evaluation criteria in solid tumors (RECIST v1.1) | 12 months | |
| Progression free survival | 12 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 |
|---|---|---|---|---|---|---|
| National Hospital; Oncotherapy Dept | Bloemfontein | 9301 | South Africa | |||
| Groote Schuur Hospital ( Uni of Capetown ); Oncology Dept |
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| Cape Town |
| 7506 |
| South Africa |
| Cape Town Oncology Trials | Cape Town | 7570 | South Africa |
| Cancercare | Cape Town | 7700 | South Africa |
| Cancercare | George | 6529 | South Africa |
| Mary Potter Oncology Centre | Groenkloof | 0181 | South Africa |
| Medical Oncology Centre of Rosebank; Oncology | Johannesburg | 2196 | South Africa |
| University of Pretoria; Department of Medical Oncology | Pretoria | 0002 | South Africa |
| Sandton Oncology Medical Group | Sandton | 2196 | South Africa |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| 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 |
|---|---|
| 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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