Metastatic Colorectal CancerPhase 2NCT00514761
Phase II Efficacy Study of AZD6244 in Colorectal Cancer
A Phase 2 study testing AZD6244 and Capecitabine in people with Metastatic Colorectal Cancer, run by AstraZeneca at 3 sites in Brazil.
Trial summary
The purpose of the study is to assess if there is benefit when using AZD6244 in the treatment if metastatic colorectal cancer in comparison with another treatment called capecitabine. This study will also assess how safe and well tolerated AZD6244 is. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- AZD6244 and Capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 3 sitesBrazil
- Study dates
- Sep 2006to Jul 2008
- 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
- colorectal cancer
- require treatment but have failed one or two previous chemotherapeutic regimens that must have included oxaliplatin and/or irinotecan
- have World Health Organisation (WHO) performance status 0-2 and life expectancy > 12 weeks
Who cannot join
- previous therapy with EGFR inhibitor, MEK inhibitor or capecitabine
- any recent surgery, unhealed surgical incision or severe concomitant condition which makes it undesirable for the patient to participate in the study
- nausea and vomiting, chronic gastrointestinal disease or significant bowel resection that would preclude adequate absorption
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites
Research Site
Goiânia
Research Site
Rio de Janeiro
Research Site
São Paulo
About this study
Official title: A Phase II, Open, Randomized Study to Assess the Efficacy and Safety of AZD6244 vs Capecitabine (Xeloda) in Patients With Colorectal Cancer Who Have Failed One or Two Prior Chemotherapeutic Regimens.
The purpose of the study is to assess if there is benefit when using AZD6244 in the treatment if metastatic colorectal cancer in comparison with another treatment called capecitabine. This study will also assess how safe and well tolerated AZD6244 is.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- AZD6244, Capecitabine
- Keywords
- colorectal cancer, AZD6244
- Medical subject headings
- Colorectal Neoplasms
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 vial
CapecitabineDrug
Also called Xeloda
oral tablet
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Xeloda Receives: Drug: Capecitabine |
| 2 | Experimental | AZD6244 Receives: Drug: AZD6244 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression event count
Measured: assessed after each visit
Secondary outcomes (1)
safety and tolerability
Measured: assessed at each visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2007 (estimated)
- Study startSep 2006
- Primary completionJun 2007
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies 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
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clive Morris, MD, Study director, AstraZenecaGill Pover, MD, Study director, AstraZenecaLance Smith, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00514761
- Sponsor's protocol ID
- D1532C00011
- Status last verified
- Aug 2014
- First submitted
- 9 Aug 2007
- Last updated
- 13 Aug 2014
- Results posted
- No
- Data monitoring committee
- 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, Open, Randomized Study to Assess the Efficacy and Safety of AZD6244 vs Capecitabine (Xeloda) in Patients With Colorectal Cancer Who Have Failed One or Two Prior Chemotherapeutic Regimens.
- ClinicalTrials.gov ID
- NCT00514761
- Acronym / sponsor ID
- D1532C00011
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- colorectal cancer, AZD6244
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 10 Aug 2007 (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 purpose of the study is to assess if there is benefit when using AZD6244 in the treatment if metastatic colorectal cancer in comparison with another treatment called capecitabine. This study will also assess how safe and well tolerated AZD6244 is.
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: CapecitabineXeloda |
| 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)
- colorectal cancer
- require treatment but have failed one or two previous chemotherapeutic regimens that must have included oxaliplatin and/or irinotecan
- have World Health Organisation (WHO) performance status 0-2 and life expectancy > 12 weeks
Key exclusion criteria (3 listed)
- previous therapy with EGFR inhibitor, MEK inhibitor or capecitabine
- any recent surgery, unhealed surgical incision or severe concomitant condition which makes it undesirable for the patient to participate in the study
- nausea and vomiting, chronic gastrointestinal disease or significant bowel resection that would preclude adequate absorption
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 vial | Drug | 2 |
| CapecitabineAlso: Xelodaoral tablet | Drug | 1 |
Primary outcome
Progression event count
Time frame: assessed after each visit
1 secondary outcome
safety and tolerability
Time frame: assessed at each visit
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.
- Related InfoLink provided by the sponsor.
- CSR-D1532C00011.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.
Clive Morris, MD study director
AstraZeneca
Gill Pover, MD study director
AstraZeneca
Lance Smith study director
AstraZeneca
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD6244 and Capecitabine in people with Metastatic Colorectal Cancer, run by AstraZeneca at 3 sites in Brazil.
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 3 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 3 sites in Brazil. 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?
Progression event count (time frame: assessed after each visit). 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; AzTrials last refreshed its copy on 7 Nov 2026.