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

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00372944
• Other study ID #: D1532C00008
• Status: Completed
• Phase: Phase 2
• First received: September 5, 2006
• Last updated: August 12, 2014
• Start date: August 2006
• Est. completion date: October 2008

Study information

• Verified date: August 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• AZD6244
oral capsule
• capecitabine
oral tablet

Locations

Country	Name	City	State
Australia	Research Site	Heidelburg
Bulgaria	Research Site	Plovdiv
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Varna
Hungary	Research Site	Budapest
Romania	Research Site	Cluj-Napoca
United States	Research Site	Alhambra	California
United States	Research Site	Ann Arbor	Michigan
United States	Research Site	Bakersfield	California
United States	Research Site	Chevy Chase	Maryland
United States	Research Site	Nashville	Tennessee
United States	Research Site	New York	New York
United States	Research Site	Orlando	Florida
United States	Research Site	Palm Springs	California
United States	Research Site	Santa Maria	California
United States	Research Site	Seattle	Washington
United States	Research Site	Temple	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Australia,  Bulgaria,  Hungary,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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)	No
Secondary	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	Yes

External Links

•   Link
•   CSR-D1532C00008.pdf