Safety Study of FLP Injection to Treat Tumor Patients

Phase 1

• Conditions: Advanced Cancer
• Interventions: Drug: FLP,dose escalation,MTD

• Registration Number: NCT01361529
• Lead Sponsor: Acea Bio (Hangzhou) Co., Ltd.

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

Study Timeline

• Study Start: 2009-06
• Status Verified: 2011-05
• Study First Submitted: 2011-05-24
• Study First Submitted QC: 2011-05-26
• Last Update Submitted: 2011-05-26
• Study First Posted: 2011-05-27
• Last Update Posted: 2011-05-27
• Primary Completion: 2011-06
• Study Completion: 2011-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
safty test	FLP,dose escalation,MTD	FLP,dose escalation,MTD

Primary Outcome Measures

Name	Time	Method
adverse effect assessment	21 days	to evlauate the symptom of adverse effect and the number of participates with adverse effect

Trial Locations

Locations (1)

GCP center,First Affiliated Hospital of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China