Solid tumors
Conditions
Interventions
A:65mg/mm2: qw×2, pause one week, to assess the safety, tolerance and pharmacokinetics of Fluorapacin Injection . Observe systemic status in the following six weeks
B:130mg/mm2: qw×2, pause one week, to assess the safety, tolerance and pharmacokinetics of Fluorapacin Injection . Observe systemic status in the following six weeks.
C:217mg/mm2: qw×2, pause one week, to assess the safety, tolerance and pharmacokinetics of Fluorapacin Injection . Observe systemic status in the following six weeks.
D:325mg/mm2: qw×2, pause one week, to assess the safety, tolerance and pharmacokinetics of Fluorapacin Injection . Observe systemic status in the following six weeks.
E:430mg/mm2: qw×2, pause one week, to assess the safety, tolerance and pharmacokinetics of Fluorapacin Injection . Observe systemic status in the following six weeks.
Sponsors
The First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. The patient's age between 18 years old and 65 years old, both male and female; 2. Confirmed advanced stage of malignant solid tumors by histological or cytological diagnosis; 3. The patients were in ineffective, lack of effective conventional treatment or refused conventional treatment; 4. The end of treatment including chemotherapy, radiotherapy, biotherapy, targeting therapy and other studies is at least four weeks from this registration to participate in this test; 5. Life expectancy of at least 12 weeks; 6. The patients were easy to observe AE and efficacy; 7. Without other accompanied anti-tumor therapies; 8. A signed informed consent must be obtained prior to performing any study specific procedures; 9. ECOG Performance Status of 0, 1; and behavior condition integration (PS)<=1.5; 10. Female: Women with childbearing potential must have a negative pregnancy test performed within 72 hours prior to treatment, or must use an approved contraceptive method during and for 3 months after the study; must have a negative serum or urine pregnancy test, and must not be breast-feeding; 11. Coagulation function is normal.
Exclusion criteria
Exclusion criteria: 1. The patient with active viral hepatitis; 2. The patient be allergic to the drugs of which molecular structure was similar to the study drug and excipient; 3. The patient be allergic to paclitaxel injection; 4. HIV positive, or with other acquired, congenital immunodeficiency, or with organ transplantation; 5. Inadequate organ function including the following: Absolute neutrophil (segmented and bands) count (ANC)1.5*upper limit of normal (ULN) or calculated creatinine clearance (CrCl)2.5*ULN if the liver has no tumor involvement, aspartate transaminase (AST) and alanine transaminase (ALT)>5*ULN if the liver has tumor involvement; 8. Bilirubin>1.5*upper limit of normal (ULN); 9. T>38 degree C or with obvious active infection which affect the trial in clinic; 10. Hypertesion not well controlled by drugs(SP>160mmHGg, DP>100mmHg); 11. The patients with obvious cardiovascular disorders (myocardial infactional, superior vena cava syndrome), or with arrthymia (long QT symdrome, unmeasurable QTc by Bazett's formula or >=480ms); 12. Ca2+, K+, Mg2+ is less than normal low limit; 13. With >Grade I peripheral nerve disorders; 14. Unrecovery from toxic reaction of previous chemotherapy and operation; 15. Palliative radiotherapy of primary lesion for osseous metastasis; 16. Any serious or uncontrollable disease concomitant systemic disorder (such as unstable respiratory disorders, cardiovascular, hepatic or kidney disorders); 17. History of nerve or psychiatric disorder or central metastasis, without asthmatic history; 18. Pregnant or breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Progression;Overall Survival, Objective Response Rate, Health Related Quality of Life, QLQ scores; | — |
Countries
China
Contacts
Public ContactQiong Zhao
Outcome results
None listed