Randomised Study to Compare the Efficacy of AZD6244 vs TMZ

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00338130

Enrollment

239

Registered

2006-06-20

Start date

2006-07-31

Completion date

2013-07-31

Last updated

2014-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

Keywords

Melanoma, Phase II, AZD6244, temozolomide

Brief summary

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

Interventions

DRUGAZD6244

Oral liquid or Capsule

DRUGTemozolomide

oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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)
Objective Response Rate	RECIST data collected as per institutional standard practise
Duration of response	RECIST data collected as per institutional standard practise

Secondary

Measure	Time frame
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)
Assessment of the safety and tolerability of AZD6244	Assessed at all visits

Countries

Argentina, Australia, Austria, Brazil, Canada, Denmark, France, Switzerland, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026