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The purpose of Segment 1 of the study is to determine the effect of ketoconazole on dasatinib. The purpose of Segment 2 is to learn how dasatinib affects tumor growth in patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dasatinib + Ketoconazole | Drug | Tablets, Oral, Segment 1: escalating single dose of dasatinib starting at 140 mg q24 hours on Day 1-8; single dose of ketoconazole 200 mg q12 hours on Days 3-8; Segment 2: single daily oral doses of dasatinib, once daily, until disease progression or unacceptable toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Segment 1: Determine whether the steady state pharmacokinetics of 20 mg of dasatinib are affected by co-administration with ketoconazole in patients with advanced solid tumors | ||
| Segment 2: Assess the pharmacodynamic activity of dasatinib |
| Measure | Description | Time Frame |
|---|---|---|
| Segment 1: Evaluate the safety and tolerability of dasatinib alone and when co-administered with ketoconazole | ||
| Segment 2: Explore the association between tumor response and the pre-clinically identified markers and other mRNA gene expression level |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lee S. Rosen M.D. | Santa Monica | California | 90404 | United States | ||
| H. Lee Moffitt Cancer Center |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069439 | Dasatinib |
| D007654 | Ketoconazole |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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|
|
| Tampa |
| Florida |
| 33612 |
| United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Md Anderson Cancer Center | Houston | Texas | 77030 | United States |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D010879 | Piperazines |