Randomised Study to Compare the Efficacy of AZD6244 vs TMZ - Full Text View

Purpose

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

Condition	Intervention	Phase
Melanoma	Drug: AZD6244 Drug: Temozolomide	Phase II

MedlinePlus related topics:

Melanoma

ChemIDplus related topics:

Temozolomide ARRY 142886

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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),
Time to death
Objective Response Rate
Duration of response

Secondary Outcome Measures:

To assess the safety and tolerability of AZD6244
To investigate the pharmacokinetics of AZD6244
To assess the efficacy of AZD6244 versus temozolomide in patients who are BRAF and BRAF and /or NRAS mutation positive

Estimated Enrollment:	182
Study Start Date:	June 2006
Estimated Study Completion Date:	January 2009

Arms	Assigned Interventions
1: Active Comparator Temozolomide	Drug: Temozolomide oral
2: Experimental AZD6244	Drug: AZD6244 oral liquid

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00338130

Show 40 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators


Study Director:	AZD6244 Medical Science Director, MD	AstraZeneca

More Information

Study ID Numbers:	D1532C00003, EUDRACT No. 2006-001456-12
First Received:	June 15, 2006
Last Updated:	December 14, 2007
ClinicalTrials.gov Identifier:	NCT00338130
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Melanoma

Phase II

AZD6244

temozolomide

Study placed in the following topic categories:

Neuroectodermal Tumors

Nevus, Pigmented

Neoplasms, Germ Cell and Embryonal

Neuroepithelioma

Nevus

Temozolomide

Neuroendocrine Tumors

Melanoma

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Neoplasms, Nerve Tissue

Nevi and Melanomas

Antineoplastic Agents, Alkylating

Alkylating Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00338130