Clinical trial NCT00936221: Comparison of AZD6244 in Combination With Dacarbazine Versus (vs) Dacarbazine Alone in BRAF Mutation Positive Melanoma Patients
Official title: A Phase II, Double-blind, Randomised Study to Assess the Efficacy of AZD6244 in Combination With Dacarbazine Compared With Dacarbazine Alone in First Line Patients With BRAF Mutation Positive Advanced Cutaneous or Unknown Primary Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma
Keywords: BRAF mutation positive
advanced melanoma
Advanced cutaneous melanoma
Unknown primary melanoma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-07-09
Enrollment: 385
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the efficacy in terms of overall survival of AZD6244 in combination with dacarbazine, compared with dacarbazine alone, in first line patients with BRAF mutation positive advanced cutaneous or unknown primary melanoma


Eligibility criteria: Inclusion Criteria:

* Histological or cytological confirmation of advanced (inoperable stage III and stage IV) cutaneous or unknown primary melanoma
* Tumor sample confirmed as BRAF mutation positive

Exclusion Criteria:

* Diagnosis of uveal or mucosal melanoma
* Any prior Investigational therapy comprising inhibitors of Ras, Raf or MEK
* Having received an investigational drug within 30 days of starting treatment, or have not recovered from side effects of an investigational drug

Primary outcomes:
measure: Overall Survival
timeFrame: From date of randomization until death, withdrawal of consent or the end of the study. The end of the study was defined as the date all AZD6244 patients had been followed for a minimum of 12 months, or the date of final analysis, whichever was later
Secondary outcomes:
measure: Progression Free Survival
timeFrame: From randomization until evidence of RECIST-defined objective disease progression or data cut off, for a minimum of 12 months since start of treatment
measure: Objective Response Rate
timeFrame: From randomization until evidence of RECIST-defined objective disease progression or data cut off, for a minimum of 12 months since start of treatment
measure: Change in Target Lesion Tumour Size at Week 12
timeFrame: randomization to week 12
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Research Site
state: Colorado
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Belo Horizonte
country: Brazil
facility: Research Site
city: Ijuí
country: Brazil
facility: Research Site
city: Porto Alegre
country: Brazil
facility: Research Site
city: Sao Paulo
country: Brazil
facility: Research Site
city: Brno
country: Czech Republic
facility: Research Site
city: Novy Jicin
country: Czech Republic
facility: Research Site
city: Praha 2
country: Czech Republic
facility: Research Site
city: Lille Cedex
country: France
facility: Research Site
city: Marseille
country: France
facility: Research Site
city: Villejuif Cedex
country: France
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Kiel
country: Germany
facility: Research Site
city: Tübingen
country: Germany
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Györ
country: Hungary
facility: Research Site
city: Székesfehérvár
country: Hungary
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
city: Nijmegen
country: Netherlands
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Houston
country: Spain
facility: Research Site
city: Málaga
country: Spain
facility: Research Site
city: Palma de Mallorca
country: Spain
facility: Research Site
city: Göteborg
country: Sweden
facility: Research Site
city: Malmö
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Zürich
country: Switzerland
facility: Research Site
city: Cambridge
country: United Kingdom
facility: Research Site
city: Chelmsford
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Newcastle upon Tyne
country: United Kingdom
facility: Research Site
city: Oxford
country: United Kingdom
facility: Research Site
city: Sutton
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Churchil Hospital, Oxford, UK
name: Mark Middleton, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute Gustave Roussy, France
name: Caroline Robert, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca, Alderley Park, UK
name: Ian Smith, Dr
role: STUDY_DIRECTOR
References:
citation: Robert C, Dummer R, Gutzmer R, Lorigan P, Kim KB, Nyakas M, Arance A, Liszkay G, Schadendorf D, Cantarini M, Spencer S, Middleton MR. Selumetinib plus dacarbazine versus placebo plus dacarbazine as first-line treatment for BRAF-mutant metastatic melanoma: a phase 2 double-blind randomised study. Lancet Oncol. 2013 Jul;14(8):733-40. doi: 10.1016/S1470-2045(13)70237-7. Epub 2013 Jun 2.