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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Melanoma

Thank you

Trial Information

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


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

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

Name

Location

Research SiteAnaheim, California  
Research SiteBoulder, Colorado  
Research SiteBoca Raton, Florida  
Research SiteArlington Heights, Illinois  
Research SiteBeverly, Massachusetts  
Research SiteBattle Kreek, Michigan  
Research SiteAlbany, New York  
Research SiteEnid, Oklahoma  
Research SiteAllentown, Pennsylvania  
Research SiteChattanooga, Tennessee