cancer
Conditions
Interventions
C1 period: GR007 90 mg, i.m., dosing for 8 consecutive days before FOLFIRI chemotherapy
Group 1:C0 period: GR007 90 mg, i.m., single dose
C1 period: GR007 90 mg, i.m., single dose before FOLFIRI chemotherapy
Group 2:C0 period: GR007 90 mg, i.m., dosing for 3 consecutive days
C1 period: GR007 90 mg, i.m., dosing for 3 consecutive days before FOLFIRI chemotherapy
Group 3:C0 period: GR007 90 mg, i.m., dosing for 5 consecutive days
C1 period: GR007 90 mg, i.m., dosing for 5 consecutive days before FOLFIRI chemotherapy
Group 4:C0 period: GR007 90 mg, i.m., dosing for 8 consecutive days
Sponsors
Shanghai Orient Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18~45 years old,no gender limited; 2. Patients with malignant tumors confirmed by histology and/or cytology, and need FOLFIRI chemotherapy; 3. ECOG PS 0-1; 4. Expected survival time is more than 3 months; 5. The toxicities and side effects caused by previous treatments need to be restored to less than grade 1 (NCI CTC 4.03, except for hair loss); 6. Have sufficient bone marrow reserve function, liver function, renal function and coagulation function: ANC=2.0×10^9/L, PLT=100×10^9/L, Hb=90g/L; TBIL=1.5×ULN, ALT=3×ULN, AST=3×ULN (patients with tumor liver metastasis: ALT=5×ULN, AST=5×ULN); Cr=1×ULN (if Cr is between 1×ULN and 1.5×ULN, calculated according to the Cockroft-Gault formula, the Cr clearance should be more than 60mL/min); INR =1.5×ULN, APTT=1.5×ULN; 7. Qualified patients with fertility(women or man) must agree with adopting reliable contraception(such as hormone, barrier method or abstinence) during this trial and within 12 weeks after the end of this drug administration. Female patients in childbearing age must be negative in blood or urine pregnancy tests within 7 days prior to enrollment; 8. Agree and voluntarily sign the informed consent before this trial;
Exclusion criteria
Exclusion criteria: 1. Have received anti-tumor therapy such as chemotherapy, biotherapy, radiation therapy, endocrine therapy, and targeted therapy within 4 weeks or 5 half-lives of the known drug (whichever is longer half-lives) prior to start of this drug administration(Ciclosporin and nitrosoureas for 6 weeks, oral fluorouracil drugs such as tegafur, capecitabine for at least 2 weeks); 2. Have received other clinical trial drug treatment within 4 weeks prior to the start of this drug administration; 3. Have received IL-1/IL-1Ra/IL-1R treatment within 4 weeks prior to the start of this drug administration; 4. Have uridine diphosphate glucuronosyltransferase (UGT) 1A1*28 gene homozygous mutant; 5. Have medical history of Immune disease, including positive HIV antibody test (using enzyme-linked immunosorbent assay or Western blot method); 6. Have medical history of severe cardiovascular disease: ventricular arrhythmia requiring clinical intervention; Have acute coronary syndrome, congestive heart failure, stroke, or other cardiovascular events of grade III or higher within 6 months; Have heart function more than grade II according New York Heart Association (NYHA) class of heart function or left ventricular ejection fraction (LVEF) < 50%; 7. Have untreated or clinically symptomatic tumor brain metastases, spinal cord compression, cancerous meningitis, or have other evidence of patient's brain and spinal cord metastases having not yet been controlled and the investigators juged for inappropriate to enter this trial; have clinical disease symptoms of suspected brain or pia mater unless be excluded by CT/MRI examination; 8. Have uncontrolled active infections; 9. HBsAg positive, or HBc antibody positive(HBV-DNA should be detected and DNA copy number is more than 500); HCV antibody positive(HCV-RNA should be detected and is positive) (Other preventive antiviral therapy but interferon is permission) ; 10. Have medical history of other serious systemic diseases, and investigator judged for inappropriate subjects in this clinical trial; 11. Known alcohol or drug dependence; 12. Subjects with mental disorders or poor compliance; 13. Women in pregnancy or breastfeeding; 14. Known to be allergic to the active ingredient of the test drug; 15. Subjects who the investigator judged for not suitable to participate in this clinical trial because of any clinical or laboratory abnormalities or other reasons;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital signs;ECOG score;Physical examination;Clinical laboratory examination;Pharmacokinetics;AE; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of CID;The duration of CID;The incidence of Grade 3-4 CID;The duration of Grade 3-4 CID;The incidence of CIN;The duration of CIN;The incidence of Grade 3-4 CIN;The duration of Grade 3-4 CIN;SAE; | — |
Countries
China
Contacts
Public ContactJin Li
Shanghai Orient Hospital
Outcome results
None listed