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

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00372944
Collaborator
(none)
70
Enrollment
17
Locations
2
Arms
26
Duration (Months)
4.1
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Aug 1, 2006
Actual Primary Completion Date :
Apr 1, 2008
Actual Study Completion Date :
Oct 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

Xeloda

Drug: capecitabine
oral tablet
Other Names:
  • Xeloda®

    		•
    Experimental: 2

    AZD6244

    Drug: AZD6244
    oral capsule
    Other Names:
  • ARRY-142886

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Alhambra California United States
    2 Research Site Bakersfield California United States
    3 Research Site Palm Springs California United States
    4 Research Site Santa Maria California United States
    5 Research Site Orlando Florida United States
    6 Research Site Chevy Chase Maryland United States
    7 Research Site Ann Arbor Michigan United States
    8 Research Site New York New York United States
    9 Research Site Nashville Tennessee United States
    10 Research Site Temple Texas United States
    11 Research Site Seattle Washington United States
    12 Research Site Heidelburg Australia
    13 Research Site Plovdiv Bulgaria
    14 Research Site Sofia Bulgaria
    15 Research Site Varna Bulgaria
    16 Research Site Budapest Hungary
    17 Research Site Cluj-Napoca Romania

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Study Director: Emerging Oncology Medical Science Director, MD, AstraZeneca

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT00372944
    Other Study ID Numbers:
    • D1532C00008
    First Posted:
    Sep 7, 2006
    Last Update Posted:
    Aug 13, 2014
    Last Verified:
    Aug 1, 2014
    Keywords provided by AstraZeneca
    advanced pancreatic cancer
    metastatic pancreatic cancer
    AZD6244
    Additional relevant MeSH terms:
    Pancreatic Neoplasms
    Capecitabine

    Study Results

    No Results Posted as of Aug 13, 2014