AZD6244 vs. Capecitabine (Xeloda®) in Patients With Advanced or Metastatic Pancreatic Cancer, Who Have Failed First Line Gemcitabine Therapy

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: AZD6244
* Drug: capecitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed with pancreatic cancer Have failed first line gemcitabine therapy Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Xeloda | Drug: capecitabine<br>* oral tablet<br>* Other names: Xeloda®;|
| Experimental: 2<br>AZD6244 | Drug: AZD6244<br>* oral capsule<br>* Other names: ARRY-142886;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Data cut off for this analysis was 5th April 2008. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. |  | Review of AEs for duration of study, from First Subject in August 2006 to Last Subject Last visit October 2008 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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advanced pancreatic cancer, metastatic pancreatic cancer, AZD6244