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| Name | Class |
|---|---|
| Fudan University | OTHER |
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The primary objective of this study is to explore the maximum tolerated dose, dose-limiting toxicity of oral Subutinib Maleate capsules and rational dosage regimen for phase â…¡ study, to investigate the pharmacokinetics of single and multiple oral doses of Subutinib Maleate capsules.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subutinib Maleate capsules | Experimental | Dose escalation will be dependent on any dose limiting toxicities |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subutinib Maleate capsules | Drug | Dose escalation will be dependent on any dose limiting toxicities |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity, maximum tolerated dose. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics | Subutinib Maleate pharmacokinetic parameters , include AUC, Cmax, Tmax, and t1/2 | 2 months |
| Pharmacodynamics | The response of Subutinib Maleate on tumor. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Li jin, doctor | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| 2 months |