Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT: 2006-003086-14 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare the efficacy and the safety Larotaxel administered as single agent every 3 weeks to continuous administration of 5-FU every 3 weeks, in patients with advanced pancreatic cancer (non operable in a curative intent, locally recurrent or metastatic) previously treated with gemcitabine based therapy.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Larotaxel (XRP9881) | Experimental |
| |
| 5-Fluorouracil or capecitabine | Active Comparator | Each Investigator must choose either IV 5-FU or oral capecitabine regimen before the first participant begins the study and has to consistently use the chosen regimen throughout the study for all participants treated at her/his site. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Larotaxel (XRP9881) | Drug | administered as a 1-hour IV infusion on Day 1 of every 3 weeks (q3w) |
|
| Measure | Description | Time Frame |
|---|---|---|
| overall survival (OS) defined as the time interval from the date of randomization to the date of death due to any cause | study period |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS); Overall Response Rate (proportion of patients with confirmed RECIST-defined complete response (CR) or partial response (PR); clinical benefit based on the measurement of tumor related symptoms; | study period |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| ICD | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Bridgewater | New Jersey | 08807 | United States | ||
| Sanofi-Aventis Administrative Office |
Not provided
Not provided
Not provided
Not provided
Not provided
| 5-Fluorouracil | Drug | administered as IV infusion from Day 1 to Day 4 |
|
| Capecitabine | Drug | administered orally from Day 1 to Day 14 q3w |
|
| Diegem |
| Belgium |
| Sanofi-Aventis Administrative Office | São Paulo | Brazil |
| Sanofi-Aventis Administrative Office | Laval, Quebec | Canada |
| Sanofi-Aventis Administrative Office | Santiago | Chile |
| Sanofi-Aventis Administrative Office | Bogotá | Colombia |
| Sanofi-Aventis Administrative Office | Prague | Czechia |
| Sanofi-Aventis Administrative Office | Helsinki | Finland |
| Sanofi-Aventis Administrative Office | Berlin | Germany |
| Sanofi-Aventis Administrative Office | Budapest | Hungary |
| Sanofi-Aventis Administrative Office | Mumbai | India |
| Sanofi-Aventis Administrative Office | Milan | Italy |
| Sanofi-Aventis Administrative Office | México | Mexico |
| Sanofi-Aventis Administrative Office | Lysaker | Norway |
| Sanofi-Aventis Administrative Office | Lima | Peru |
| Sanofi-Aventis Administrative Office | Warsaw | Poland |
| Sanofi-Aventis Administrative Office | Moscow | Russia |
| Sanofi-Aventis Administrative Office | Brastislava | Slovakia |
| Sanofi-Aventis Administrative Office | Madrid | Spain |
| Sanofi-Aventis Administrative Office | Istanbul | Turkey (Türkiye) |
| Sanofi-Aventis Administrative Office | Guildford, Surrey | United Kingdom |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C531079 | larotaxel |
| D005472 | Fluorouracil |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided