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

Phase 2

Completed

• Conditions: Pancreatic Cancer
• Interventions: Drug: capecitabine; Drug: AZD6244

• Registration Number: NCT00372944
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-09-05
• Study First Submitted QC: 2006-09-05
• Study First Posted: 2006-09-07
• Primary Completion: 2008-04
• Study Completion: 2008-10
• Disposition First Submitted: 2013-07-22
• Disposition First Submitted QC: 2013-07-22
• Disposition First Posted: 2013-07-24
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-12
• Last Update Posted: 2014-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	capecitabine	Xeloda
2	AZD6244	AZD6244

Primary Outcome Measures

Name	Time	Method
Median time to death (TTD)	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 Outcome Measures

Name	Time	Method
Progression event count	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
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

Trial Locations

Locations (1)

Research Site; 🇷🇴 Cluj-Napoca, Romania