AZD6244 vs. Capecitabine (Xeloda®) in Patients With Advanced or Metastatic Pancreatic Cancer, Who Have Failed First Line Gemcitabine Therapy
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
1 other identifier
interventional
70
5 countries
17
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 pancreatic-cancer
Started Aug 2006
Shorter than P25 for phase_2 pancreatic-cancer
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 5, 2006
CompletedFirst Posted
Study publicly available on registry
September 7, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedAugust 13, 2014
August 1, 2014
1.7 years
September 5, 2006
August 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Progression event count
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
Study Arms (2)
1
ACTIVE COMPARATORXeloda
2
EXPERIMENTALAZD6244
Interventions
Eligibility Criteria
You may qualify if:
- Confirmed with pancreatic cancer
- Have failed first line gemcitabine therapy
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (17)
Research Site
Alhambra, California, United States
Research Site
Bakersfield, California, United States
Research Site
Palm Springs, California, United States
Research Site
Santa Maria, California, United States
Research Site
Orlando, Florida, United States
Research Site
Chevy Chase, Maryland, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
New York, New York, United States
Research Site
Nashville, Tennessee, United States
Research Site
Temple, Texas, United States
Research Site
Seattle, Washington, United States
Research Site
Heidelburg, Australia
Research Site
Plovdiv, Bulgaria
Research Site
Sofia, Bulgaria
Research Site
Varna, Bulgaria
Research Site
Budapest, Hungary
Research Site
Cluj-Napoca, Romania
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Emerging Oncology Medical Science Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2006
First Posted
September 7, 2006
Study Start
August 1, 2006
Primary Completion
April 1, 2008
Study Completion
October 1, 2008
Last Updated
August 13, 2014
Record last verified: 2014-08