Pancreatic CancerPhase 2NCT00372944
AZD6244 vs. Capecitabine (Xeloda®) in Patients With Advanced or Metastatic Pancreatic Cancer, Who Have Failed First Line Gemcitabine Therapy
A Phase 2 study testing AZD6244 and capecitabine in people with Pancreatic Cancer, run by AstraZeneca at 17 sites in 5 countries.
Trial summary
The purpose of this study is to assess the efficacy and safety of AZD6244 (ARRY-142886)versus capecitabine in patients with advanced or metastatic pancreatic cancer who have failed first-line therapy with gemcitabine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic 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
- 70 participants
- Where
- 17 sitesin 5 countries
- Study dates
- Aug 2006to Oct 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
- Confirmed with pancreatic cancer
- Have failed first line gemcitabine therapy
Who cannot join
- Previous therapy with EGFR inhibitor, MEK inhibitor or capecitabine.
- Any recent surgery, unhealed surgical incision or severe condition such as uncontrolled cardiac disease or chronic gastrointestinal diseases.
Trial locations and contacts
17 sites in 5 countries.
17 sites in 5 countries
United States11 sites
Research Site
Alhambra, California
Research Site
Ann Arbor, Michigan
Research Site
Bakersfield, California
Research Site
Chevy Chase, Maryland
Research Site
Nashville, Tennessee
Research Site
New York, New York
Research Site
Orlando, Florida
Research Site
Palm Springs, California
Research Site
Santa Maria, California
Research Site
Seattle, Washington
Research Site
Temple, Texas
About this study
Official title: A Phase II, Open, Randomised Study to Assess the Efficacy and Safety of AZD6244 vs. Capecitabine (Xeloda®) in Patients With Advanced or Metastatic Pancreatic Cancer, Who Have Failed First Line Gemcitabine Therapy
The purpose of this study is to assess the efficacy and safety of AZD6244 (ARRY-142886)versus capecitabine in patients with advanced or metastatic pancreatic cancer who have failed first-line therapy with gemcitabine. Following baseline assessments, a minimum of 64 patients in approximately 5-6 centers from the US will be treated with either AZD6244 or capecitabine. Treatment will be continued for as long as the patients receive clinical benefit. The status of all patients will be checked (whether they are still taking treatment or not) approximately 3 months after the last patient has entered the study.
- Conditions
- Pancreatic Cancer
- Being tested
- AZD6244, capecitabine
- Keywords
- advanced pancreatic cancer, metastatic pancreatic cancer, AZD6244
- Medical subject headings
- Pancreatic 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 capsule
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.
Median time to death (TTD)
The TTD (days) was calculated as the interval from date of randomisation to date of patient death (from any cause). Patients who had not died at the time of the final analysis were censored at the last date the patient was known to be alive. Median TTD in days is presented here.
Measured: Data cut off for this analysis was 5th April 2008.
Secondary outcomes (2)
Progression event count
The number of patients with a progression event occurring on or before MTAV where an event is defined as Objective and/or clinical disease progression as measured using RECIST criteria, or death from any cause
Measured: The mandatory tumour assessment visit (MTAV) occurred on 27th February 2008 (+/-3days)
To assess the safety and tolerability of AZD6244 in the treatment of advanced or metastatic pancreatic cancer by review of adverse events (AEs) and laboratory parameters.
Measured: Review of AEs for duration of study, from First Subject in August 2006 to Last Subject Last visit October 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2006 (estimated)
- Study startAug 2006
- Primary completionApr 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emerging Oncology Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00372944
- Sponsor's protocol ID
- D1532C00008
- Status last verified
- Aug 2014
- First submitted
- 5 Sep 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, Open, Randomised Study to Assess the Efficacy and Safety of AZD6244 vs. Capecitabine (Xeloda®) in Patients With Advanced or Metastatic Pancreatic Cancer, Who Have Failed First Line Gemcitabine Therapy
- ClinicalTrials.gov ID
- NCT00372944
- Acronym / sponsor ID
- D1532C00008
- Conditions
- Pancreatic Cancer
- Keywords
- advanced pancreatic cancer, metastatic pancreatic cancer, AZD6244
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 7 Sep 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 purpose of this study is to assess the efficacy and safety of AZD6244 (ARRY-142886)versus capecitabine in patients with advanced or metastatic pancreatic cancer who have failed first-line therapy with gemcitabine. Following baseline assessments, a minimum of 64 patients in approximately 5-6 centers from the US will be treated with either AZD6244 or capecitabine. Treatment will be continued for as long as the patients receive clinical benefit. The status of all patients will be checked (whether they are still taking treatment or not) approximately 3 months after the last patient has entered the study.
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 (2 listed)
- Confirmed with pancreatic cancer
- Have failed first line gemcitabine therapy
Key exclusion criteria (2 listed)
- Previous therapy with EGFR inhibitor, MEK inhibitor or capecitabine.
- Any recent surgery, unhealed surgical incision or severe condition such as uncontrolled cardiac disease or chronic gastrointestinal diseases.
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 capsule | Drug | 2 |
| capecitabineAlso: Xeloda®oral tablet | Drug | 1 |
Primary outcome
Median time to death (TTD)
Time frame: Data cut off for this analysis was 5th April 2008.
The TTD (days) was calculated as the interval from date of randomisation to date of patient death (from any cause). Patients who had not died at the time of the final analysis were censored at the last date the patient was known to be alive. Median TTD in days is presented here.
2 secondary outcomes
Progression event count
Time frame: The mandatory tumour assessment visit (MTAV) occurred on 27th February 2008 (+/-3days)
To assess the safety and tolerability of AZD6244 in the treatment of advanced or metastatic pancreatic cancer by review of adverse events (AEs) and laboratory parameters.
Time frame: Review of AEs for duration of study, from First Subject in August 2006 to Last Subject Last visit October 2008
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-D1532C00008.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.
Emerging Oncology Medical Science Director, MD study director
AstraZeneca
17 sites in 5 countries: 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 Pancreatic Cancer, run by AstraZeneca at 17 sites in 5 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 2 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 17 sites in United States, Bulgaria, Australia, Hungary, Romania. 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?
Median time to death (TTD) (time frame: Data cut off for this analysis was 5th April 2008.). 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.