AZD6244 vs. Capecitabine (Xeloda®) in Patients With Advanced or Metastatic Pancreatic Cancer, Who Have Failed First Line Gemcitabine Therapy
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ClinicalTrials.gov Identifier: NCT00372944 |
Recruitment Status :
Completed
First Posted : September 7, 2006
Last Update Posted : August 13, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pancreatic Cancer | Drug: AZD6244 Drug: capecitabine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
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 : | August 2006 |
Actual Primary Completion Date : | April 2008 |
Actual Study Completion Date : | October 2008 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Xeloda
|
Drug: capecitabine
oral tablet
Other Name: Xeloda® |
Experimental: 2
AZD6244
|
Drug: AZD6244
oral capsule
Other Name: ARRY-142886 |
- Median time to death (TTD) [ Time Frame: 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.
- Progression event count [ Time Frame: 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. [ Time Frame: Review of AEs for duration of study, from First Subject in August 2006 to Last Subject Last visit October 2008 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00372944
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 |
Study Director: | Emerging Oncology Medical Science Director, MD | AstraZeneca |
Additional Information:
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00372944 History of Changes |
Other Study ID Numbers: |
D1532C00008 |
First Posted: | September 7, 2006 Key Record Dates |
Last Update Posted: | August 13, 2014 |
Last Verified: | August 2014 |
advanced pancreatic cancer metastatic pancreatic cancer AZD6244 |
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Capecitabine |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |