Title

Safety Study of FLP Injection to Treat Tumor Patients
Phase 1 Study of FLP Injection on Tumor Patients
  • Phase

    Phase 1
  • Study Type

    Interventional
  • Status

    Unknown status
  • Intervention/Treatment

    fluorapacin ...
  • Study Participants

    30
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
Study Started
Jun 30
2009
Primary Completion
Jun 30
2011
Anticipated
Study Completion
Jul 31
2011
Anticipated
Last Update
May 27
2011
Estimate

Drug FLP,dose escalation,MTD

dosage from 93mg/m2 to 331mg/m2, 7 days' continuous dosing, 21 days for one cycle

  • Other names: Fluorapacin

safty test Experimental

FLP,dose escalation,MTD

Criteria

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
No Results Posted