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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2008-10-31

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.

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Detailed Description

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Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Xeloda

Group Type ACTIVE_COMPARATOR

capecitabine

Intervention Type DRUG

oral tablet

2

AZD6244

Group Type EXPERIMENTAL

AZD6244

Intervention Type DRUG

oral capsule

Interventions

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AZD6244

oral capsule

Intervention Type DRUG

capecitabine

oral tablet

Intervention Type DRUG

Other Intervention Names

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ARRY-142886 Xeloda®

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No