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OpenTrials
Completed

NCT Number: NCT00338130

Randomised Study to Compare the Efficacy of AZD6244 vs TMZ

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

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Ciudad de Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD6244

Drug

Oral liquid or Capsule

Other names: ARRY-142886

Temozolomide

Drug

oral

Primary outcomes

  1. 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 frame: From date of randomisation until 6 months after first dose or study withdrawal (whichever is the earliest)

  2. Time to death

    Time frame: From date of randomisation until 6 months after first dose or to date of death (whichever is the earliest)

  3. Objective Response Rate

    Time frame: RECIST data collected as per institutional standard practise

  4. Duration of response

    Time frame: RECIST data collected as per institutional standard practise

Secondary outcomes

  1. Assessment of the safety and tolerability of AZD6244

    Time frame: Assessed at all visits

  2. Investigation of the pharmacokinetics of AZD6244

    Time frame: Day 1 & 8 (for patients on AZD6244)

  3. Assessment of the efficacy of AZD6244 versus temozolomide in patients who are BRAF and BRAF and /or NRAS mutation positive

    Time frame: From date of randomisation until 6 months after first dose or study withdrawal (whichever is the earliest)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2013
First posted
Jun 20, 2006
Registry last updated
Aug 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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