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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00372944




Registration number
NCT00372944
Ethics application status
Date submitted
5/09/2006
Date registered
7/09/2006
Date last updated
13/08/2014

Titles & IDs
Public title
AZD6244 vs. Capecitabine (Xeloda®) in Patients With Advanced or Metastatic Pancreatic Cancer, Who Have Failed First Line Gemcitabine Therapy
Scientific 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
Secondary ID [1] 0 0
D1532C00008
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AZD6244
Treatment: Drugs - capecitabine

Active Comparator: 1 - Xeloda

Experimental: 2 - AZD6244


Treatment: Drugs: AZD6244
oral capsule

Treatment: Drugs: capecitabine
oral tablet

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Data cut off for this analysis was 5th April 2008.
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
The mandatory tumour assessment visit (MTAV) occurred on 27th February 2008 (+/-3days)
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Review of AEs for duration of study, from First Subject in August 2006 to Last Subject Last visit October 2008

Eligibility
Key inclusion criteria
- Confirmed with pancreatic cancer

- Have failed first line gemcitabine therapy
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Heidelburg
Recruitment postcode(s) [1] 0 0
- Heidelburg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Washington
Country [9] 0 0
Bulgaria
State/province [9] 0 0
Plovdiv
Country [10] 0 0
Bulgaria
State/province [10] 0 0
Sofia
Country [11] 0 0
Bulgaria
State/province [11] 0 0
Varna
Country [12] 0 0
Hungary
State/province [12] 0 0
Budapest
Country [13] 0 0
Romania
State/province [13] 0 0
Cluj-Napoca

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT00372944
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Emerging Oncology Medical Science Director, MD
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications