AZD6244 Vs. Capecitabine (Xeloda®) In Patients With Advanced Or Metastatic Pancreatic Cancer, Who Have Failed First Line Gemcitabine Therapy

Study Overview

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.

N/A

Pancreatic Cancer

DRUG: AZD6244
DRUG: capecitabine

D1532C00008

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2006-09-05	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2014-08-12
First Submitted that Met QC Criteria 2006-09-05	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2014-08-13
First Posted (ESTIMATED) 2006-09-07	Results First Posted N/A	Last Verified 2014-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: 1 Xeloda	DRUG: capecitabine oral tablet
EXPERIMENTAL: 2 AZD6244	DRUG: AZD6244 oral capsule

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: 1

Xeloda

DRUG: capecitabine

oral tablet

EXPERIMENTAL: 2

AZD6244

DRUG: AZD6244

oral capsule

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Confirmed with pancreatic cancer
Have failed first line gemcitabine therapy

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Emerging Oncology Medical Science Director, MD, AstraZeneca

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record