Safety Study of FLP Injection to Treat Tumor Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01361529
Recruitment Status : Unknown
Verified May 2011 by Acea Bio (Hangzhou) Co., Ltd..
Recruitment status was:  Recruiting
First Posted : May 27, 2011
Last Update Posted : May 27, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: FLP,dose escalation,MTD Phase 1

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of FLP Injection on Tumor Patients
Study Start Date : June 2009
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : July 2011

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 Name: Fluorapacin

Primary Outcome Measures :
  1. adverse effect assessment [ Time Frame: 21 days ]
    to evlauate the symptom of adverse effect and the number of participates with adverse effect

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01361529

Contact: jianzhong shentu, doctor +86-571-87236560
Contact: lihua wu, doctor +86-571-87236560

China, Zhejiang
GCP center,First Affiliated Hospital of Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310003
Contact: jianzhong shentu, professor    +86-571-87236560   
Sub-Investigator: qiong zhao, professor         
Sub-Investigator: weijia fang, doctor         
Sponsors and Collaborators
Acea Bio (Hangzhou) Co., Ltd.
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

Responsible Party: Wanhong Xu,Deputy General Manager, Acea Bio (Hangzhou) Co., Ltd. Identifier: NCT01361529     History of Changes
Other Study ID Numbers: ACEA100108(FLP)
First Posted: May 27, 2011    Key Record Dates
Last Update Posted: May 27, 2011
Last Verified: May 2011

Keywords provided by Acea Bio (Hangzhou) Co., Ltd.:
dose escalation