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Completed

NCT Number: NCT00372944

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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Heidelburg, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AZD6244

Drug

oral capsule

Other names: ARRY-142886

Capecitabine

Drug

oral tablet

Other names: Xeloda®

Primary outcomes

  1. 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.

Secondary outcomes

  1. Progression event count

    Time frame: The mandatory tumour assessment visit (MTAV) occurred on 27th February 2008 (+/-3days)

    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

  2. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Sep 7, 2006
Registry last updated
Aug 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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