Clinical trial NCT00372944: AZD6244 vs. Capecitabine (Xeloda®) in Patients With Advanced or Metastatic Pancreatic Cancer, Who Have Failed First Line Gemcitabine Therapy
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: advanced pancreatic cancer
metastatic pancreatic cancer
AZD6244
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-09-07
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Median time to death (TTD)
timeFrame: Data cut off for this analysis was 5th April 2008.
Secondary outcomes:
measure: Progression event count
timeFrame: The mandatory tumour assessment visit (MTAV) occurred on 27th February 2008 (+/-3days)
measure: 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.
timeFrame: Review of AEs for duration of study, from First Subject in August 2006 to Last Subject Last visit October 2008
Other outcomes:
Locations:
city: Alhambra
country: United States
facility: Research Site
state: California
city: Bakersfield
country: United States
facility: Research Site
state: California
city: Palm Springs
country: United States
facility: Research Site
state: California
city: Santa Maria
country: United States
facility: Research Site
state: California
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Chevy Chase
country: United States
facility: Research Site
state: Maryland
city: Ann Arbor
country: United States
facility: Research Site
state: Michigan
city: New York
country: United States
facility: Research Site
state: New York
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Temple
country: United States
facility: Research Site
state: Texas
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Heidelburg
country: Australia
facility: Research Site
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Varna
country: Bulgaria
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Cluj-Napoca
country: Romania
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Emerging Oncology Medical Science Director, MD
role: STUDY_DIRECTOR
References: