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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) and 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 |
|---|---|---|---|
| Arm 1 | Experimental | Volociximab administered intravenously at a dose of 10 mg/kg qowk |
|
| Arm 2 | Experimental | Volociximab administered intravenously at a dose of 15 mg/kg qwk |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Volociximab (anti-α5β1 integrin monoclonal antibody) | Drug | Volociximab intravenously (Cohort 1: 10 mg/kg every other week or Cohort 2: 15 mg/kg once a week) for up to 104 weeks or until disease progression, whichever occurs first. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with a confirmed tumor response at any time during the study | Any time during the study |
| Measure | Description | Time Frame |
|---|---|---|
| Time to disease progression | Up to 104 weeks | |
| Duration of tumor response | Up to 104 weeks | |
| Pharmacokinetics (PK) of M200 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Mihail Obrocea, MD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 70400 | Los Angeles | California | 90095 | United States | ||
| Site Reference ID/Investigator# 70401 |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D009362 | Neoplasm Metastasis |
| D009369 | Neoplasms |
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D007680 | Kidney Neoplasms |
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| ID | Term |
|---|---|
| C516631 | volociximab |
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| Day 0 through Study Termination |
| Immunogenicity | Day 0 through Study Termination |
| New York |
| New York |
| 10021 |
| United States |
| Site Reference ID/Investigator# 70399 | Cleveland | Ohio | 44195 | United States |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |