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Phase 1 Study of FLP Injection on Tumor Patients

Phase 1
18 Years
70 Years
Open (Enrolling)
Advanced Cancer

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Trial Information

Phase 1 Study of FLP Injection on 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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

adverse effect assessment

Outcome Description:

to evlauate the symptom of adverse effect and the number of participates with adverse effect

Outcome Time Frame:

21 days

Safety Issue:


Principal Investigator

jianying zhou, professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

First Affiliated Hospital of Zhejiang University


China: Food and Drug Administration

Study ID:




Start Date:

June 2009

Completion Date:

July 2011

Related Keywords:

  • Advanced Cancer
  • dose escalation
  • Neoplasms