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The purpose of this study is to determine the tolerance and maximum tolerated dose (MTD) for FLP Injection with multiple dose in tumor patients.
To determine the tolerance and MTD for FLP Injection with multiple dose in tumor patients.
To test clinical pharmacokinetics (PK) and PK parameter
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| safty test | Experimental | FLP,dose escalation,MTD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FLP,dose escalation,MTD | Drug | dosage from 93mg/m2 to 331mg/m2, 7 days' continuous dosing, 21 days for one cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| adverse effect assessment | to evlauate the symptom of adverse effect and the number of participates with adverse effect | 21 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jianzhong shentu, doctor | Contact | +86-571-87236560 | stjzcn@yahoo.com.cn | |
| lihua wu, doctor | Contact | +86-571-87236560 |
| Name | Affiliation | Role |
|---|---|---|
| jianying zhou, professor | First Affiliated Hospital of Zhejiang University | Principal Investigator |
| nong xu, professor | First Affiliated Hospital of Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GCP center,First Affiliated Hospital of Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310003 | China |
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| ID | Term |
|---|---|
| C528265 | fluorapacin |
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| jianzhong shentu, professor | First Affiliated Hospital of Zhejiang University | Principal Investigator |