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The purpose of this clinical study is to evaluate the safety and tolerability of CT-322 monotherapy to determine the recommended dose for phase II and subsequent studies
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-844203 (CT-322) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-844203 (CT-322) | Drug | Injection, IV, 1 and 2 mg/kg, Weekly, Until disease progression or unacceptable toxicity became apparent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine recommended dose for Phase 2 study of CT-322 | Within the first 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the plasma pharmacokinetics of CT-322. Pharmacokinetics of CT-322 will be derived from plasma concentration versus time data. The pharmacokinetic parameters to be assessed include Cmax, Cmin, Tmax, AUC (INF), AUC (TAU), T-HALF, etc. | Cycle 1: Day 1 to 5, 8, 15, 22 to 26 and 29 | |
| To assess the plasma pharmacokinetics of CT-322. Pharmacokinetics of CT-322 will be derived from plasma concentration versus time data. The pharmacokinetic parameters to be assessed include Cmax, Cmin, Tmax, AUC (INF), AUC (TAU), T-HALF, etc. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Osaka-Sayama-Shi | Osaka | 5898511 | Japan |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C549678 | CT-322 |
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| Cycle 2 and beyond (up to 6 cycle): Day 1 at each cycle and then every 3 cycles thereafter |
| To assess anti-tumor activity of CT-322 | Every 8 weeks |
| To assess the effects of CT-322 on plasma VEGF levels | Cycle 1: Day 1, 3, 8, 15, 22 |
| To assess the effects of CT-322 on plasma VEGF levels | Cycle 3: Day 1 |
| To assess the presence of anti CT-322 antibodies | Cycle 1: Day 1, 15, 22 and 29 |
| To assess the presence of anti CT-322 antibodies | Cycle 3 and beyond (up to 6 cycle): Day 1 at each cycle and then every 3 cycles thereafter |