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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00372944
First received: September 5, 2006
Last updated: July 22, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Pancreatic Cancer
Drug: AZD6244
Drug: capecitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Median time to death (TTD) [ Time Frame: Data cut off for this analysis was 5th April 2008. ] [ Designated as safety issue: No ]
    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:
  • Progression event count [ Time Frame: The mandatory tumour assessment visit (MTAV) occurred on 27th February 2008 (+/-3days) ] [ Designated as safety issue: No ]
    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. [ Time Frame: Review of AEs for duration of study, from First Subject in August 2006 to Last Subject Last visit October 2008 ] [ Designated as safety issue: Yes ]

Enrollment: 70
Study Start Date: August 2006
Study Completion Date: October 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Xeloda
Drug: capecitabine
oral tablet
Other Name: Xeloda®
Experimental: 2
AZD6244
Drug: AZD6244
oral capsule
Other Name: ARRY-142886

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00372944

Locations
United States, California
Research Site
Alhambra, California, United States
Research Site
Bakersfield, California, United States
Research Site
Palm Springs, California, United States
Research Site
Santa Maria, California, United States
United States, Florida
Research Site
Orlando, Florida, United States
United States, Maryland
Research Site
Chevy Chase, Maryland, United States
United States, Michigan
Research Site
Ann Arbor, Michigan, United States
United States, New York
Research Site
New York, New York, United States
United States, Tennessee
Research Site
Nashville, Tennessee, United States
United States, Texas
Research Site
Temple, Texas, United States
United States, Washington
Research Site
Seattle, Washington, United States
Australia
Research Site
Heidelburg, Australia
Bulgaria
Research Site
Plovdiv, Bulgaria
Research Site
Sofia, Bulgaria
Research Site
Varna, Bulgaria
Hungary
Research Site
Budapest, Hungary
Romania
Research Site
Cluj-Napoca, Romania
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Emerging Oncology Medical Science Director, MD AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00372944     History of Changes
Other Study ID Numbers: D1532C00008
Study First Received: September 5, 2006
Last Updated: July 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
advanced pancreatic cancer
metastatic pancreatic cancer
AZD6244

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Capecitabine
Fluorouracil
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on April 15, 2014