Safety Study of FLP Injection to Treat Tumor Patients

Phase 1 Study of FLP Injection on Tumor Patients

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

Study Overview

• Status: Unknown
• Conditions: Advanced Cancer
• Intervention / Treatment: Drug: FLP,dose escalation,MTD

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: jianzhong shentu, doctor; Phone Number: +86-571-87236560; Email: stjzcn@yahoo.com.cn
• Study Contact Backup: Name: lihua wu, doctor; Phone Number: +86-571-87236560

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Recruiting
      • GCP center,First Affiliated Hospital of Zhejiang University
      • Contact: jianzhong shentu, professor; Phone Number: +86-571-87236560; Email: stjzcn@yahoo.com.cn
      • Sub-Investigator: qiong zhao, professor
      • Sub-Investigator: weijia fang, doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: safty test; FLP,dose escalation,MTD	Drug: FLP,dose escalation,MTD; dosage from 93mg/m2 to 331mg/m2, 7 days' continuous dosing, 21 days for one cycle; Other Names: Fluorapacin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse effect assessment	to evlauate the symptom of adverse effect and the number of participates with adverse effect	21 days

Collaborators and Investigators

• Sponsor: Acea Bio (Hangzhou) Co., Ltd.
• Investigators: Principal Investigator: jianying zhou, professor, First Affiliated Hospital of Zhejiang University; Principal Investigator: nong xu, professor, First Affiliated Hospital of Zhejiang University; Principal Investigator: jianzhong shentu, professor, First Affiliated Hospital of Zhejiang University

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Anticipated): June 1, 2011
• Study Completion (Anticipated): July 1, 2011

Study Registration Dates

• First Submitted: May 24, 2011
• First Submitted That Met QC Criteria: May 26, 2011
• First Posted (Estimate): May 27, 2011

Study Record Updates

• Last Update Posted (Estimate): May 27, 2011
• Last Update Submitted That Met QC Criteria: May 26, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: dose escalation
• Other Study ID Numbers: ACEA100108(FLP)