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This clinical trial is being conducted to determine tumor response and preliminary safety of a monoclonal antibody that specifically binds to a cell surface receptor (α5β1 integrin) that is required for the establishment of new blood vessels during tumor growth, a process known as angiogenesis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Volociximab (10 mg/kg every other week (qowk)) and Gemcitabine |
|
| Cohort 2 | Experimental | Volociximab (15 mg/kg weekly (qwk)) and Gemcitabine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Volociximab | Drug | Volociximab: 10 mg/kg or 15mg/kg every week or every other week (qowk) via IV infusion for up to 104 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients, in each dose cohort, with a confirmed tumor response | Any time during the course of the trial (up to 104 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of progression-free survival | During the course of the trial (up to 104 weeks) | |
| Time to disease progression | During the course of the trial (up to 104 weeks) | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mihail Obrocea, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 70538 | Pittsburgh | Pennsylvania | 15213 | United States | ||
| Site Reference ID/Investigator# 70537 |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D002277 | Carcinoma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C516631 | volociximab |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Gemcitabine | Drug | Gemcitabine: Standard chemotherapy regime at 1 g/m2 once per week for 3 weeks via IV infusion, followed by one week with no treatment |
|
| Duration of overall survival |
| During the course of the trial (up to 104 weeks) |
| To evaluate the safety in of M200 in combination with gemcitabine | During the course of the trial (up to 104 weeks) |
| To evaluate the pharmacokinetics of M200 | During the course of the trial (up to 104 weeks) |
| To evaluate the immunogenicity of M200 | During the course of the trial (up to 104 weeks) |
| Nashville |
| Tennessee |
| 37232-7415 |
| United States |
| Site Reference ID/Investigator# 70534 | Glasgow | G12 0YN | United Kingdom |
| Site Reference ID/Investigator# 70533 | Leeds | LS16 6QB | United Kingdom |
| Site Reference ID/Investigator# 70536 | Manchester | M20 4BX | United Kingdom |
| Site Reference ID/Investigator# 70535 | Northwood | HA6 2RN | United Kingdom |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |