Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT No. 2006-001456-12 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary purpose of this study is to compare the efficacy of AZD6244 (ARRY-142886) with temozolomide in patients with advanced melanoma
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Temozolomide |
|
| 2 | Experimental | AZD6244 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD6244 | Drug | Oral liquid or Capsule |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare the efficacy of AZD6244 vs temozolomide in patients with unresectable AJCC stage 3 or 4 malignant melanoma by assessing progression free survival (PFS) | From date of randomisation until 6 months after first dose or study withdrawal (whichever is the earliest) | |
| Time to death | From date of randomisation until 6 months after first dose or to date of death (whichever is the earliest) | |
| Objective Response Rate | RECIST data collected as per institutional standard practise | |
| Duration of response | RECIST data collected as per institutional standard practise |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the safety and tolerability of AZD6244 | Assessed at all visits | |
| Investigation of the pharmacokinetics of AZD6244 | Day 1 & 8 (for patients on AZD6244) | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| AZD6244 Medical Science Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Santa Monica | California | United States | |||
| Research Site |
Not provided
| Label | URL |
|---|---|
| CSR-1839IL-0151.pdf | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Temozolomide |
| Drug |
oral |
|
| Assessment of the efficacy of AZD6244 versus temozolomide in patients who are BRAF and BRAF and /or NRAS mutation positive |
| From date of randomisation until 6 months after first dose or study withdrawal (whichever is the earliest) |
| Aurora |
| Colorado |
| United States |
| Research Site | Miami Beach | Florida | United States |
| Research Site | Niles | Illinois | United States |
| Research Site | Boston | Massachusetts | United States |
| Research Site | Buffalo | New York | United States |
| Research Site | New York | New York | United States |
| Research Site | Oklahoma City | Oklahoma | United States |
| Research Site | Pittsburgh | Pennsylvania | United States |
| Research Site | Nashville | Tennessee | United States |
| Research Site | Ciudad de Buenos Aires | Argentina |
| Research Site | Vicente López | Argentina |
| Research Site | Heidelberg | Australia |
| Research Site | Nedlands | Australia |
| Research Site | Waratah | Australia |
| Research Site | Sankt Pölten | Austria |
| Research Site | Vienna | Austria |
| Research Site | Belo Horizonte | Brazil |
| Research Site | Curitiba | Brazil |
| Research Site | Goiânia | Brazil |
| Research Site | Porto Alegre | Brazil |
| Research Site | Salvador | Brazil |
| Research Site | São Paulo | Brazil |
| Research Site | Oshawa | Ontario | Canada |
| Research Site | Montreal | Quebec | Canada |
| Research Site | Odense | Denmark |
| Research Site | Boulogne-Billancourt | France |
| Research Site | Nantes | France |
| Research Site | Villejuif | France |
| Research Site | Zurich | Switzerland |
| Research Site | Glasgow | United Kingdom |
| Research Site | London | United Kingdom |
| Research Site | Oxford | United Kingdom |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C517975 | AZD 6244 |
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided