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| Name | Class |
|---|---|
| Exelixis | INDUSTRY |
To determine safety, tolerability and maximum tolerated dose of BMS-63233/XL413 in subjects with Refractory Hematologic Cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cdc7-inhibitor (A) | Active Comparator |
| |
| Cdc7-inhibitor (B) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cdc7-inhibitor (BMS-863233) | Drug | Tablets, Oral, QD x 14 days until MTD is achieved, 14 days per 28 day cycle/QD, 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine maximum tolerated dose and anti-tumor activity of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer | Every 21 or 28 days until maximum tolerated dose is reached |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the safety of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer | Every 21 or 28 days until the MTD is reached | |
| To determine the pharmacokinetics of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer |
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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 |
|---|---|---|---|---|---|---|
| University Of Miami | Miami | Florida | 33136 | United States | ||
| H. Lee Moffitt Cancer Center & Research Institute |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Cdc7-inhibitor (BMS-863233) | Drug | Tablets, Oral, MTD of Cdc7-inhibitor (A) Arm, QD x 7 days until MTD achieved, 7 days per 21 day cycle/QD, 12 months |
|
|
| Every 21 or 28 days until the MTD is reached |
| To determine the anti-tumor activity of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer | Every 21 or 28 days until the MTD is reached |
| Tampa |
| Florida |
| 33612 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Roswell Park | Buffalo | New York | 14263 | United States |