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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Xeloda |
|
| 2 | Experimental | AZD6244 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD6244 | Drug | oral capsule |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emerging Oncology Medical Science Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Alhambra | California | United States | |||
| Research Site |
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| Label | URL |
|---|---|
| Related Info | View source |
| CSR-D1532C00008.pdf | View source |
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| capecitabine |
| Drug |
oral tablet |
|
|
| 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 |
| Bakersfield |
| California |
| United States |
| Research Site | Palm Springs | California | United States |
| Research Site | Santa Maria | California | United States |
| Research Site | Orlando | Florida | United States |
| Research Site | Chevy Chase | Maryland | United States |
| Research Site | Ann Arbor | Michigan | United States |
| Research Site | New York | New York | United States |
| Research Site | Nashville | Tennessee | United States |
| Research Site | Temple | Texas | United States |
| Research Site | Seattle | Washington | United States |
| Research Site | Heidelburg | Australia |
| Research Site | Plovdiv | Bulgaria |
| Research Site | Sofia | Bulgaria |
| Research Site | Varna | Bulgaria |
| Research Site | Budapest | Hungary |
| Research Site | Cluj-Napoca | Romania |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C517975 | AZD 6244 |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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