MelanomaPhase 2NCT00338130
Randomised Study to Compare the Efficacy of AZD6244 vs TMZ
A Phase 2 study testing AZD6244 and Temozolomide in people with Melanoma, run by AstraZeneca at 33 sites in 10 countries.
Trial summary
The primary purpose of this study is to compare the efficacy of AZD6244 (ARRY-142886) with temozolomide in patients with advanced melanoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- AZD6244 and Temozolomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 239 participants
- Where
- 33 sitesin 10 countries
- Study dates
- Jul 2006to Jul 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Any previous radiotherapy or chemotherapy (palliative radiotherapy is acceptable)
- Participation in any other trial with an investigational product within the previous 30 days
Trial locations and contacts
33 sites in 10 countries.
33 sites in 10 countries
United States10 sites
Research Site
Aurora, Colorado
Research Site
Boston, Massachusetts
Research Site
Buffalo, New York
Research Site
Miami Beach, Florida
Research Site
Nashville, Tennessee
Research Site
New York, New York
Research Site
Niles, Illinois
Research Site
Oklahoma City, Oklahoma
Research Site
Pittsburgh, Pennsylvania
Research Site
Santa Monica, California
Brazil6 sites
Research Site
Belo Horizonte
Research Site
Curitiba
Research Site
Goiânia
Research Site
Porto Alegre
Research Site
Salvador
Research Site
São Paulo
Australia3 sites
Research Site
Heidelberg
Research Site
Nedlands
Research Site
Waratah
France3 sites
Research Site
Boulogne-Billancourt
Research Site
Nantes
Research Site
Villejuif
United Kingdom3 sites
Research Site
Glasgow
Research Site
London
Research Site
Oxford
Argentina2 sites
Research Site
Ciudad de Buenos Aires
Research Site
Vicente López
About this 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
The primary purpose of this study is to compare the efficacy of AZD6244 (ARRY-142886) with temozolomide in patients with advanced melanoma
- Conditions
- Melanoma
- Being tested
- AZD6244, Temozolomide
- Keywords
- Melanoma, Phase II, AZD6244, temozolomide
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD6244Drug
Also called ARRY-142886
Oral liquid or Capsule
TemozolomideDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Temozolomide Receives: Drug: Temozolomide |
| 2 | Experimental | AZD6244 Receives: Drug: AZD6244 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From date of randomisation until 6 months after first dose or study withdrawal (whichever is the earliest)
Time to death
Measured: From date of randomisation until 6 months after first dose or to date of death (whichever is the earliest)
Objective Response Rate
Measured: RECIST data collected as per institutional standard practise
Duration of response
Measured: RECIST data collected as per institutional standard practise
Secondary outcomes (3)
Assessment of the safety and tolerability of AZD6244
Measured: Assessed at all visits
Investigation of the pharmacokinetics of AZD6244
Measured: 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
Measured: From date of randomisation until 6 months after first dose or study withdrawal (whichever is the earliest)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2006 (estimated)
- Study startJul 2006
- Primary completionSep 2007
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AZD6244 Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00338130
- Sponsor's protocol ID
- D1532C00003
- Other IDs
- EUDRACT No. 2006-001456-12
- Status last verified
- Aug 2014
- First submitted
- 15 Jun 2006
- Last updated
- 13 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00338130
- Acronym / sponsor ID
- D1532C00003
- Conditions
- Melanoma
- Keywords
- Melanoma, Phase II, AZD6244, temozolomide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 20 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to compare the efficacy of AZD6244 (ARRY-142886) with temozolomide in patients with advanced melanoma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: TemozolomideTemozolomide |
| 2 | Experimental | Drug: AZD6244AZD6244 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Any previous radiotherapy or chemotherapy (palliative radiotherapy is acceptable)
- Participation in any other trial with an investigational product within the previous 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD6244Also: ARRY-142886Oral liquid or Capsule | Drug | 2 |
| Temozolomideoral | Drug | 1 |
Primary outcome
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)
Time to death
Time frame: From date of randomisation until 6 months after first dose or to date of death (whichever is the earliest)
Objective Response Rate
Time frame: RECIST data collected as per institutional standard practise
Duration of response
Time frame: RECIST data collected as per institutional standard practise
3 secondary outcomes
Assessment of the safety and tolerability of AZD6244
Time frame: Assessed at all visits
Investigation of the pharmacokinetics of AZD6244
Time frame: 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
Time frame: From date of randomisation until 6 months after first dose or study withdrawal (whichever is the earliest)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2014.
- CSR-1839IL-0151.pdfLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AZD6244 Medical Science Director, MD study director
AstraZeneca
33 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD6244 and Temozolomide in people with Melanoma, run by AstraZeneca at 33 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Brazil, Australia, France, United Kingdom and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2014.