Melanoma Clinical Trial
Official title:
A Phase II, Multi-centre, Open-Label, Parallel Group, Randomised Study To Compare the Efficacy of AZD6244 vs Temozolomide in Patients With Unresectable AJCC Stage 3 or 4 Malignant Melanoma
| Verified date | August 2014 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The primary purpose of this study is to compare the efficacy of AZD6244 (ARRY-142886) with temozolomide in patients with advanced melanoma
| Status | Completed |
| Enrollment | 239 |
| Est. completion date | July 2013 |
| Est. primary completion date | September 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Diagnosed with late stage malignant melanoma - Aged 18 or over - Female patients must be post-menopausal or with negative urine pregnancy test if pre-menopausal Exclusion Criteria: - Any previous radiotherapy or chemotherapy (palliative radiotherapy is acceptable) - Participation in any other trial with an investigational product within the previous 30 days |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Research Site | Ciudad de Buenos Aires | |
| Argentina | Research Site | Vicente Lopez | |
| Australia | Research Site | Heidelberg | |
| Australia | Research Site | Nedlands | |
| Australia | Research Site | Waratah | |
| Austria | Research Site | St. Pölten | |
| Austria | Research Site | Wien | |
| Brazil | 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 | |
| Canada | Research Site | Montreal | Quebec |
| Canada | Research Site | Oshawa | Ontario |
| Denmark | Research Site | Odense | |
| France | Research Site | Boulogne Billancourt | |
| France | Research Site | Nantes Cedex 1 | |
| France | Research Site | Villejuif Cedex | |
| Switzerland | Research Site | Zürich | |
| United Kingdom | Research Site | Glasgow | |
| United Kingdom | Research Site | London | |
| United Kingdom | Research Site | Oxford | |
| United States | Research Site | Aurora | Colorado |
| United States | Research Site | Boston | Massachusetts |
| United States | Research Site | Buffalo | New York |
| United States | Research Site | Miami Beach | Florida |
| United States | Research Site | Nashville | Tennessee |
| United States | Research Site | New York | New York |
| United States | Research Site | Niles | Illinois |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Pittsburgh | Pennsylvania |
| United States | Research Site | Santa Monica | California |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States, Argentina, Australia, Austria, Brazil, Canada, Denmark, France, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | No | |
| Primary | Time to death | From date of randomisation until 6 months after first dose or to date of death (whichever is the earliest) | No | |
| Primary | Objective Response Rate | RECIST data collected as per institutional standard practise | No | |
| Primary | Duration of response | RECIST data collected as per institutional standard practise | No | |
| Secondary | Assessment of the safety and tolerability of AZD6244 | Assessed at all visits | Yes | |
| Secondary | Investigation of the pharmacokinetics of AZD6244 | Day 1 & 8 (for patients on AZD6244) | Yes | |
| Secondary | 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) | No |
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