Safety Study of FLP Injection to Treat Tumor Patients

NCT ID: NCT01361529

Last Updated: 2011-05-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2011-07-31

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

Conditions

Advanced Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

safty test

FLP,dose escalation,MTD

Group Type: EXPERIMENTAL

FLP,dose escalation,MTD

Intervention Type: DRUG

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

Interventions

FLP,dose escalation,MTD

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

Intervention Type: DRUG

Other Intervention Names

Fluorapacin

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Acea Bio (Hangzhou) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Acea Bio (Hangzhou) Co., Ltd.

Principal Investigators

jianying zhou, professor

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Zhejiang University

nong xu, professor

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Zhejiang University

jianzhong shentu, professor

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Zhejiang University

Locations

GCP center,First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

jianzhong shentu, doctor

Role: CONTACT

stjzcn@yahoo.com.cn

+86-571-87236560

lihua wu, doctor

Role: CONTACT

+86-571-87236560

Facility Contacts

jianzhong shentu, professor

Role: primary

stjzcn@yahoo.com.cn

+86-571-87236560

Other Identifiers

ACEA100108(FLP)

Identifier Type: -

Identifier Source: org_study_id