Randomised Study to Compare the Efficacy of AZD6244 vs TMZ

Phase 2

Completed

• Conditions: Melanoma
• Interventions: Drug: AZD6244; Drug: Temozolomide

• Registration Number: NCT00338130
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-06-15
• Study First Submitted QC: 2006-06-16
• Study First Posted: 2006-06-20
• Study Start: 2006-07
• Primary Completion: 2007-09
• Study Completion: 2013-07
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-12
• Last Update Posted: 2014-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 239

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	AZD6244	AZD6244
1	Temozolomide	Temozolomide

Primary Outcome Measures

Name	Time	Method
Objective Response Rate	RECIST data collected as per institutional standard practise
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)	From date of randomisation until 6 months after first dose or study withdrawal (whichever is the earliest)
Time to death	From date of randomisation until 6 months after first dose or to date of death (whichever is the earliest)
Duration of response	RECIST data collected as per institutional standard practise

Secondary Outcome Measures

Name	Time	Method
Assessment of the safety and tolerability of AZD6244	Assessed at all visits
Investigation of the pharmacokinetics of AZD6244	Day 1 & 8 (for patients on AZD6244)
Assessment of the efficacy of AZD6244 versus temozolomide in patients who are BRAF and BRAF and /or NRAS mutation positive	From date of randomisation until 6 months after first dose or study withdrawal (whichever is the earliest)

Trial Locations

Locations (1)

Research Site; 🇬🇧 Oxford, United Kingdom