Safety Study of FLP Injection to Treat Tumor Patients

ACEA Biosciences

Status and phase

Unknown

Phase 1

Conditions

Advanced Cancer

Treatments

Drug: FLP,dose escalation,MTD

Study type

Interventional

Funder types

Industry

Identifiers

NCT01361529

ACEA100108(FLP)

Details and patient eligibility

About

The purpose of this study is to determine the tolerance and maximum tolerated dose (MTD) for FLP Injection with multiple dose in tumor patients.

Full description

To determine the tolerance and MTD for FLP Injection with multiple dose in tumor patients.

To test clinical pharmacokinetics (PK) and PK parameter

Enrollment

30 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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