NCT00338130

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
239

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2006

Longer than P75 for phase_2

Geographic Reach
9 countries

31 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 20, 2006

Completed
11 days until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
5.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

August 13, 2014

Status Verified

August 1, 2014

Enrollment Period

1.2 years

First QC Date

June 15, 2006

Last Update Submit

August 12, 2014

Conditions

Melanoma

Keywords

MelanomaPhase IIAZD6244temozolomide

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (3)

  • 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)

Study Arms (2)

1

ACTIVE COMPARATOR

Temozolomide

Drug: Temozolomide

2

EXPERIMENTAL

AZD6244

Drug: AZD6244

Interventions

AZD6244DRUG

Oral liquid or Capsule

Also known as: ARRY-142886
2
TemozolomideDRUG

oral

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Any previous radiotherapy or chemotherapy (palliative radiotherapy is acceptable)
  • Participation in any other trial with an investigational product within the previous 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (33)

Research Site

Santa Monica, California, United States

Location

Research Site

Aurora, Colorado, United States

Location

Research Site

Miami Beach, Florida, United States

Location

Research Site

Niles, Illinois, United States

Location

Research Site

Boston, Massachusetts, United States

Location

Research Site

Buffalo, New York, United States

Location

Research Site

New York, New York, United States

Location

Research Site

Oklahoma City, Oklahoma, United States

Location

Research Site

Pittsburgh, Pennsylvania, United States

Location

Research Site

Nashville, Tennessee, United States

Location

Research Site

Ciudad de Buenos Aires, Argentina

Location

Research Site

Vicente López, Argentina

Location

Research Site

Heidelberg, Australia

Location

Research Site

Nedlands, Australia

Location

Research Site

Waratah, Australia

Location

Research Site

Sankt Pölten, Austria

Location

Research Site

Vienna, Austria

Location

Research Site

Belo Horizonte, Brazil

Location

Research Site

Curitiba, Brazil

Location

Research Site

Goiânia, Brazil

Location

Research Site

Porto Alegre, Brazil

Location

Research Site

Salvador, Brazil

Location

Research Site

São Paulo, Brazil

Location

Research Site

Oshawa, Ontario, Canada

Location

Research Site

Montreal, Quebec, Canada

Location

Research Site

Odense, Denmark

Location

Research Site

Boulogne-Billancourt, France

Location

Research Site

Nantes, France

Location

Research Site

Villejuif, France

Location

Research Site

Zurich, Switzerland

Location

Research Site

Glasgow, United Kingdom

Location

Research Site

London, United Kingdom

Location

Research Site

Oxford, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Melanoma

Interventions

AZD 6244Temozolomide

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • AZD6244 Medical Science Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2006

First Posted

June 20, 2006

Study Start

July 1, 2006

Primary Completion

September 1, 2007

Study Completion

July 1, 2013

Last Updated

August 13, 2014

Record last verified: 2014-08

Locations

BR(6)AU(3)DK(1)FR(3)CA(2)AR(2)GB(3)US(10)CH(1)