Comparison of AZD6244 in Combination With Dacarbazine Versus (vs) Dacarbazine Alone in BRAF Mutation Positive Melanoma Patients

Melanoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00936221
• Other study ID #: D1532C00006
• Status: Completed
• Phase: Phase 2
• First received: July 8, 2009
• Last updated: February 11, 2016
• Start date: July 2009
• Est. completion date: November 2014

Study information

• Verified date: February 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 385
• Est. completion date: November 2014
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 130 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• AZD6244
oral capsules, 75mg twice daily
• Dacarbazine
1000 mg/m2 iv infusion over at least 60 min. on day 1 of each 21 cycle
• Placebo
Placebo

Locations

Country	Name	City	State
Brazil	Research Site	Belo Horizonte
Brazil	Research Site	Ijuí
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Sao Paulo
Czech Republic	Research Site	Brno
Czech Republic	Research Site	Novy Jicin
Czech Republic	Research Site	Praha 2
France	Research Site	Lille Cedex
France	Research Site	Marseille
France	Research Site	Villejuif Cedex
Germany	Research Site	Berlin
Germany	Research Site	Essen
Germany	Research Site	Hannover
Germany	Research Site	Kiel
Germany	Research Site	Tübingen
Hungary	Research Site	Budapest
Hungary	Research Site	Györ
Hungary	Research Site	Székesfehérvár
Netherlands	Research Site	Amsterdam
Netherlands	Research Site	Nijmegen
Norway	Research Site	Oslo
Spain	Research Site	Barcelona
Spain	Research Site	Houston
Spain	Research Site	Málaga
Spain	Research Site	Palma de Mallorca
Sweden	Research Site	Göteborg
Sweden	Research Site	Malmö
Sweden	Research Site	Stockholm
Switzerland	Research Site	Zürich
United Kingdom	Research Site	Cambridge
United Kingdom	Research Site	Chelmsford
United Kingdom	Research Site	London
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Newcastle upon Tyne
United Kingdom	Research Site	Oxford
United Kingdom	Research Site	Sutton
United States	Research Site	Aurora	Colorado
United States	Research Site	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Brazil,  Czech Republic,  France,  Germany,  Hungary,  Netherlands,  Norway,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	Following progression survival data was collected until documentation of death, withdrawal of consent, loss to follow-up or the final data cut-off, whichever occurred first.	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	No
Secondary	Progression Free Survival	PFS is the time from randomisation until the date of objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) or death (by any cause in the absence of progression). Progression is defined using RECIST (v1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.	From randomization until evidence of RECIST-defined objective disease progression or data cut off, for a minimum of 12 months since start of treatment	No
Secondary	Objective Response Rate	ORR rate is defined as the number (%) of subjects with at least one visit response of Complete Response (CR) or Partial Response (PR) , as defined by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions and assessed by CT or MRI. CR, Disappearance of all target lesions; PR, =30% decrease in the sum of the longest diameter of target lesions. Data obtained up until progression, or last evaluable assessment in the absence of progression, was included in the assessment of ORR	From randomization until evidence of RECIST-defined objective disease progression or data cut off, for a minimum of 12 months since start of treatment	No
Secondary	Change in Target Lesion Tumour Size at Week 12		randomization to week 12	No

External Links

•   Link
•   Cancer Study Locator (US and Canada only)
•   D1532C00006.pdf