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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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)

Outcome Time Frame:

From date of randomisation until 6 months after first dose or study withdrawal (whichever is the earliest)

Safety Issue:

No

Principal Investigator

AZD6244 Medical Science Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

D1532C00003

NCT ID:

NCT00338130

Start Date:

July 2006

Completion Date:

January 2014

Related Keywords:

• Melanoma
• Melanoma
• Phase II
• AZD6244
• temozolomide
• Melanoma