Safety Study of FLP Injection to Treat Tumor Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Acea Bio (Hangzhou) Co., Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Acea Bio (Hangzhou) Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01361529
First received: May 24, 2011
Last updated: May 26, 2011
Last verified: May 2011
  Purpose

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 Intervention Phase
Advanced Cancer
Drug: FLP,dose escalation,MTD
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study of FLP Injection on Tumor Patients

Resource links provided by NLM:


Further study details as provided by Acea Bio (Hangzhou) Co., Ltd.:

Primary Outcome Measures:
  • adverse effect assessment [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
    to evlauate the symptom of adverse effect and the number of participates with adverse effect


Estimated Enrollment: 30
Study Start Date: June 2009
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01361529

Contacts
Contact: jianzhong shentu, doctor +86-571-87236560 stjzcn@yahoo.com.cn
Contact: lihua wu, doctor +86-571-87236560

Locations
China, Zhejiang
GCP center,First Affiliated Hospital of Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310003
Contact: jianzhong shentu, professor    +86-571-87236560    stjzcn@yahoo.com.cn   
Sub-Investigator: qiong zhao, professor         
Sub-Investigator: weijia fang, doctor         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Wanhong Xu,Deputy General Manager, Acea Bio (Hangzhou) Co., Ltd.
ClinicalTrials.gov Identifier: NCT01361529     History of Changes
Other Study ID Numbers: ACEA100108(FLP)
Study First Received: May 24, 2011
Last Updated: May 26, 2011
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 22, 2014