advanced solid tumor
Conditions
Interventions
24mg/m2 of dose escalation group :24mg/m2
30mg/m2 of dose escalation group:30mg/m2
36mg/m2 of dose escalation group:36mg/m2
40mg/m2 of dose escalation group:40mg/m2
24mg/m2 of dose expansion group :24mg/m2
30mg/m2 of dose expansion group:30mg/m2
36mg/m2 of dose expansion group:36mg/m2
40mg/m2 of dose expansion group:40mg/m2
Sponsors
affiliated hospital of hebei uniwersity
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) The subjects voluntarily participate in the research and sign the informed consent; 2) Age 18-65 years old, male or female; 3) Patients with advanced solid tumor confirmed by histopathology/cytology; 4) Patients with advanced solid tumors who are judged by the investigator to be ineffective in conventional treatment or lack effective treatment, including currently no standard treatment, patients unable to tolerate standard treatment, etc.; 5) There is at least one measurable lesion that meets the definition of RECIST 1.1 at baseline; 6) Eastern Cooperative Oncology Group (ECOG) score of 0 to 1; 7) The toxicity of previous anti-tumor therapy has recovered to = grade 1 (except for hair loss, pigmentation or other toxicity that is considered to have no safety risk to the subjects in the study); 8) The laboratory test values ??of the subjects meet the following requirements: Absolute neutrophil value (ANC) = 1.5x109/L (no G-CSF whitening treatment within 2 weeks before laboratory examination); Hemoglobin (Hb) = 9.0 g/dL (without receiving red blood cell transfusion therapy within 2 weeks before the laboratory test); Platelets = 100x109/L (do not receive platelet transfusion therapy within 2 weeks before the laboratory test); Creatinine=1.5x ULN; Total bilirubin=1.5x ULN; Alanine aminotransferase (AST), aspartate aminotransferase (ALT) = 3x ULN; Coagulation function: prothrombin time (PT), international normalized ratio (INR) = 1.5x ULN; 9) Female subjects with negative urine or blood HCG (except for menopause and hysterectomy); subjects and their partners take effective contraceptive measures during the trial period to 6 months after the end of the last medication.
Exclusion criteria
Exclusion criteria: 1) Severe allergy to mitoxantrone or liposomal drugs; 2) Subjects with brain or meningeal metastases; 3) Survival period 480 ms; ? Complete left bundle branch block, second or third degree AV block; ? Severe, uncontrolled cardiac arrhythmias requiring medical treatment; ? History of chronic congestive heart failure, NYHA grade =3; ? Cardiac ejection fraction less than 50% within 6 months prior to screening; ? Heart valve disease with CTCAE = grade 3; ? Uncontrolled hypertension (defined as systolic blood pressure =160 mmHg or diastolic blood pressure =100 mmHg measured under medication control); ? History of myocardial infarction, unstable angina, severe pericardial disease, electrocardiographic evidence of acute ischemia or severe conduction system abnormalities within 6 months prior to screening. 12) Have received doxorubicin or other anthracycline therapy, and the cumulative dose of doxorubicin exceeds 350 mg/m2 (anthracycline equivalent dose calculation: 1 mg doxorubicin = 2 mg epirubicin = 2 mg Pirarubicin = 2 mg daunorubicin = 0.5 mg daunorubicin = 0.45 mg mitoxantrone; doxorubicin liposomes are not calculated for cumulative dose); 13) Lactating women; 14) Suffering from any serious and/or uncontrollable disease, which, as determined by the investigator, may affect the patient's participation in this study (including but not limited to: uncontrolled diabetes, kidney disease requiring dialysis, severe liver disease, life-threatening autoimmune and bleeding disorders, substance abuse, neurological disorders, etc.); Circumstances deemed inappropriate by other investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| dose limiting toxicity;Treatment-emergent adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum concentration;Time to reach maximum concentration;Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration;Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity;Half-time;Clearance;Volume of Distribution; | — |
Countries
CHINA
Contacts
Public ContactGuo Fengxue
The Second Affiliated Hospital of Xingtai Medical College
Outcome results
None listed