Safety Study of FLP Injection to Treat Tumor Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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To determine the tolerance and MTD for FLP Injection with multiple dose in tumor patients. To test clinical pharmacokinetics (PK) and PK parameter

Official Title
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Phase 1 Study of FLP Injection on Tumor Patients

Conditions
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Advanced Cancer

Intervention / Treatment
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* Drug: FLP,dose escalation,MTD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged from 18 to 70 years old, male or female; histologically or cytologically proven advanced malignant solid tumors; cancer patients after conventional treatment failure and lack of effective treatment, or patients refusing effective treatment of existing practices; patients receiving the last treatment (chemotherapy, radiotherapy, biological therapy, targeted therapy, or other study drugs) for at least 4 weeks; expected survival time>3 months; ECOG score 0-1 Exclusion Criteria: viral activity in patients allergic to drugs or excipients; hypersensitivity to paclitaxel injection patients; HIV antibody positive, or suffering from other acquired and congenital immune deficiency disease, or history of organ transplantation; neutrophil count <1.5 × 109 / L, platelets <100 × 109 / L, or hemoglobin <90g / L; normal serum creatinine higher than 1.5 times the upper limit of reference range or the muscle of liver clearance <60ml/min; no case of liver ALT or AST> 2.5 times the upper limit of normal, or liver metastases than normal under the ALT or AST 5 times upper limit of reference range; fever or body temperature above 38 ℃ can be clinically significant impact on clinical trials of active infection; medications failed to control hypertension (systolic pressure is over 160 mmHg or diastolic pressure over 100mmHg); significant cardiovascular abnormalities (such as myocardial infarction, superior vena cava syndrome), or clinically significant arrhythmias (such as long QT syndrome, Corrected QTc not be measured or ≧ 480 ms); calcium, potassium, magnesium ions below the lower limit of normal; > I-level peripheral neuropathy Prior to the toxicity of anticancer therapy has not been restored or not from the surgery before full recovery; bone metastases for the primary lesion of palliative radiotherapy; any clinical problems can not control (such as the serious mental, neurological, cardiovascular, respiratory and other diseases); a tumor metastasis, or a variety of mental disorders center; no history of asthma; pregnancy or breast-feeding women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: safty test<br>FLP,dose escalation,MTD | Drug: FLP,dose escalation,MTD<br>* dosage from 93mg/m2 to 331mg/m2, 7 days' continuous dosing, 21 days for one cycle<br>* Other names: Fluorapacin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse effect assessment | to evlauate the symptom of adverse effect and the number of participates with adverse effect | 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dose escalation