Clinical trial NCT01361529: Safety Study of FLP Injection to Treat Tumor Patients
Official title: Phase 1 Study of FLP Injection on Tumor Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Cancer
Keywords: dose escalation
Lead sponsor: Acea Bio (Hangzhou) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-05-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

To test clinical pharmacokinetics (PK) and PK parameter

Eligibility 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

Primary outcomes:
measure: adverse effect assessment
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: GCP center,First Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: First Affiliated Hospital of Zhejiang University
name: jianying zhou, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital of Zhejiang University
name: nong xu, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital of Zhejiang University
name: jianzhong shentu, professor
role: PRINCIPAL_INVESTIGATOR
References: