Clinical trial NCT00338130: Randomised Study to Compare the Efficacy of AZD6244 vs TMZ
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma
Keywords: Melanoma
Phase II
AZD6244
temozolomide
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-06-20
Enrollment: 239
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to compare the efficacy of AZD6244 (ARRY-142886) with temozolomide in patients with advanced melanoma


Eligibility criteria: 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

Primary outcomes:
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)
timeFrame: From date of randomisation until 6 months after first dose or study withdrawal (whichever is the earliest)
measure: Time to death
timeFrame: From date of randomisation until 6 months after first dose or to date of death (whichever is the earliest)
measure: Objective Response Rate
timeFrame: RECIST data collected as per institutional standard practise
measure: Duration of response
timeFrame: RECIST data collected as per institutional standard practise
Secondary outcomes:
measure: Assessment of the safety and tolerability of AZD6244
timeFrame: Assessed at all visits
measure: Investigation of the pharmacokinetics of AZD6244
timeFrame: Day 1 & 8 (for patients on AZD6244)
measure: Assessment of the efficacy of AZD6244 versus temozolomide in patients who are BRAF and BRAF and /or NRAS mutation positive
timeFrame: From date of randomisation until 6 months after first dose or study withdrawal (whichever is the earliest)
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Research Site
state: California
city: Aurora
country: United States
facility: Research Site
state: Colorado
city: Miami Beach
country: United States
facility: Research Site
state: Florida
city: Niles
country: United States
facility: Research Site
state: Illinois
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Buffalo
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Ciudad de Buenos Aires
country: Argentina
facility: Research Site
city: Vicente Lopez
country: Argentina
facility: Research Site
city: Heidelberg
country: Australia
facility: Research Site
city: Nedlands
country: Australia
facility: Research Site
city: Waratah
country: Australia
facility: Research Site
city: St. Pölten
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Belo Horizonte
country: Brazil
facility: Research Site
city: Curitiba
country: Brazil
facility: Research Site
city: Goiânia
country: Brazil
facility: Research Site
city: Porto Alegre
country: Brazil
facility: Research Site
city: Salvador
country: Brazil
facility: Research Site
city: São Paulo
country: Brazil
facility: Research Site
city: Oshawa
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Odense
country: Denmark
facility: Research Site
city: Boulogne Billancourt
country: France
facility: Research Site
city: Nantes Cedex 1
country: France
facility: Research Site
city: Villejuif Cedex
country: France
facility: Research Site
city: Zürich
country: Switzerland
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Oxford
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AZD6244 Medical Science Director, MD
role: STUDY_DIRECTOR
References: