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This study is to define the pharmacokinetics and to evaluate the safety of BAY73-4506, 160 mg once daily administered orally as a single agent in Japanese patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regorafenib (BAY73-4506) | Drug | The patients will be treated on Day 1 of the first week followed by 6 days off treatment (Cycle 0, single dosing period). After Cycle 0, the patients will be treated with BAY 73-4506 (160 mg once daily orally, 21 days on/ 7 days off schedule). Dose level : 160 mgDose level-1: 120 mgDose level-2: 60 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Grade 4 neutropenia for >/= 7 days, febrile neutropenia with Grade 4 neutropenia, Grade 4 thrombocytopenia, Grade 3 or 4 non-hematologic toxicity, hypertension and skin toxicity of Grade 3 or 4 which are not manageable and pharmacokinetics | After 5 weeks (after Cycle 1). |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarker | At screening | |
| Response rate | Every 8 weeks for the first 6 cycles. After Cycle 6, every 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kashiwa-shi | Chiba | 277-8577 | Japan | |||
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C559147 | regorafenib |
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|
| Hidaka |
| Saitama |
| 350-1298 |
| Japan |
| Chuo-ku | Tokyo | 104-0045 | Japan |
| Mitaka | Tokyo | 181-8611 | Japan |