NCT01361529

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2009

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 27, 2011

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

May 27, 2011

Status Verified

May 1, 2011

Enrollment Period

2 years

First QC Date

May 24, 2011

Last Update Submit

May 26, 2011

Conditions

Advanced Cancer

Keywords

dose escalation

Outcome Measures

Primary Outcomes (1)

  • adverse effect assessment

    to evlauate the symptom of adverse effect and the number of participates with adverse effect

    21 days

Study Arms (1)

safty test

EXPERIMENTAL

FLP,dose escalation,MTD

Drug: FLP,dose escalation,MTD

Interventions

FLP,dose escalation,MTDDRUG

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

Also known as: Fluorapacin
safty test

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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);
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GCP center,First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Interventions

fluorapacin

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

jianzhong shentu, doctor

CONTACT

+86-571-87236560stjzcn@yahoo.com.cn

lihua wu, doctor

CONTACT

+86-571-87236560

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 24, 2011

First Posted

May 27, 2011

Study Start

June 1, 2009

Primary Completion

June 1, 2011

Study Completion

July 1, 2011

Last Updated

May 27, 2011

Record last verified: 2011-05

Locations

CN(1)