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| ID | Type | Description | Link |
|---|---|---|---|
| I4N-MC-CXBA | Other Identifier | Eli Lilly and Company |
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Study CXBA is a multicenter nonrandomized, dose escalation, open-label, Phase 1 study of intravenous LY2624587 in patients with advanced or metastatic cancer for which no treatment of higher priority exists.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2624587 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2624587 | Drug | 6-900 mg, administered intravenously, weekly for a minimum of one (1) 28 day cycle. If patients are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days). |
| Measure | Description | Time Frame |
|---|---|---|
| Recommended dose for Phase 2 studies | Baseline to study completion |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with clinically significant effects | Baseline to cycle 12 | |
| Radiological tumor measurement | Baseline, Cycle 1 Day-1, Cycle 2 - Day 1, Cycle 3 - Day 1 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hour EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Scottsdale | Arizona | 85258 |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000609602 | LY2624587 |
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| Pharmacokinetics of LY2624587, area under the concentration-time curve (AUC) |
| Cycle 1 - Cycle 12 |
| Pharmacodynamic, maximum peak concentration (Cmax). | Baseline to date last subject discontinues from study drug |
| United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | San Antonio | Texas | 78229 | United States |