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The purpose of this study is to assess the safety and tolerability of KRN951 administered to patients with solid tumors. In the single dose period, patients in each cohort will receive one oral dose of KRN951 in the first day, followed by a 6-day rest period during which no treatment is received. After that, patients in each cohort will receive one oral dose of KRN951 daily over a 21-day treatment period, followed by a 7-day rest period during which no treatment is received. Treatment will be continued in the absence of disease progression or unacceptable adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KRN951 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KRN951 | Drug | Orally once daily administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| To define the maximum tolerated dose (MTD) of KRN-951 when administered orally for 21 days followed by a 7-day rest period. | ||
| To evaluate the safety profile and the tolerability of KRN951 throughout the study period by assessing adverse events and laboratory values recorded during treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the pharmacokinetics of KRN951 in serum | ||
| To describe biological and clinical anti-tumor activity |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shizuoka | Japan |
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| ID | Term |
|---|---|
| C553176 | tivozanib |
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