Safety Study of FLP Injection to Treat Tumor Patients

Advanced Cancer Clinical Trial

Official title:

Phase 1 Study of FLP Injection on Tumor Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01361529
• Other study ID #: ACEA100108(FLP)
• Status: Recruiting
• Phase: Phase 1
• First received: May 24, 2011
• Last updated: May 26, 2011
• Start date: June 2009
• Est. completion date: July 2011

Study information

• Verified date: May 2011
• Source: Acea Bio (Hangzhou) Co., Ltd.
• Contact: jianzhong shentu, doctor
• Phone: +86-571-87236560
• Email: stjzcn[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

To determine the tolerance and MTD for FLP Injection with multiple dose in tumor patients.

To test clinical pharmacokinetics (PK) and PK parameter

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Cancer

Intervention

Drug:
• FLP,dose escalation,MTD
dosage from 93mg/m2 to 331mg/m2, 7 days' continuous dosing, 21 days for one cycle

Locations

Country	Name	City	State
China	GCP center,First Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Acea Bio (Hangzhou) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adverse effect assessment	to evlauate the symptom of adverse effect and the number of participates with adverse effect	21 days	Yes