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This will be an uncontrolled, open-label, non-randomized, phase I study. The primary objectives of this study are to define the pharmacokinetics (PK) and to evaluate the safety and tolerability of Regorafenib administered orally as a single agent in Chinese patients with advanced solid tumors. The secondary objectives are to evaluate tumor response of patients treated with Regorafenib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regorafenib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regorafenib (Stivarga, BAY73-4506) | Drug | 160 mg oral once daily BAY 73-4506 for 3 weeks of every 4 week cycle (i.e. 3 weeks on, 1 week off) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics as measured by cmax and AUC | Cycle 0, Day 1-5,Cycle 1 Day 1,8,15,21,Cycle 2 Day 1,Modified Dosing Cycle Day 21 | |
| Adverse Event collection | every 1-2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Objective tumor response rate | Every 8 weeks for the first 6 cycles, afterwards every 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory biomarker analysis | Screening, Cycle 0 or 1 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shatin | N.T | Hong Kong | ||||
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C559147 | regorafenib |
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| Hong Kong |
| Hong Kong |
| Singapore | 119228 | Singapore |
| Singapore | 169610 | Singapore |