tumours
Conditions
Interventions
Group A:The first cycle received the subject formulation (T, Docetaxel Injection Concentrate (self-emulsifying), 75 mg/m2) and the second cycle received the reference formulation (R, Docetaxel docetax
GroupB :Cycle 1 received the reference formulation (R, Tesodi, 75 mg/m2) and Cycle 2 received the subject formulation (T, docetaxel injectable concentrate (self-emulsifying), 75 mg/m2)
Sponsors
Clinical Trial Center of Third Xiangya Hospital of Central South University
Department of Oncology, Xiangya Third Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Volunteers must meet all of the following criteria to be selected: 1) Age 18~70 years old (including boundary value), both male and female; 2) Weight = 45kg; 3) Volunteers (including partners) who do not plan to have a pregnancy from 2 weeks prior to dosing to 6 months after the last dose of study drug and who voluntarily use effective contraception. Volunteers (including partners) are not planning a pregnancy and are voluntarily using effective contraception within 6 months of the last study drug administration; 4) Histologically or cytologically confirmed diagnosis of breast cancer or non-small cell lung cancer, locally advanced or metastatic breast cancer or locally advanced breast cancer as assessed by a combination of histological or imaging studies. (d) Histologically or cytologically diagnosed breast cancer or non-small cell lung cancer that is locally advanced or metastatic as assessed by a combination of histological or imaging studies, or locally advanced or metastatic non-small cell lung cancer that, in the judgement of the investigator, is likely to benefit from docetaxel therapy benefit from treatment with docetaxel, as determined by the investigator; 5) Patients with an ECOG score of 0-1; 6) Patients with an expected survival of = 3 months; 7) Clinical laboratory tests meet the following requirements: a) Neutrophil count =1.5 x 10^9/L. b) Haemoglobin =9.5 x 10^9/L; b) Haemoglobin = 9.0 g/dL; c) Platelets = 90 x 10^9/L; d) Activated partial thromboplastin time (APTT) or/and prothrombin international normalised ratio (INR) and prothrombin time (PT) =1.0 x 10^9L. Time (PT) = 1.5 x ULN; e) Creatinine = 1.5 x ULN; 8) Volunteers are able to communicate well with the investigator and complete the study in accordance with the study regulations; 9) Sign the informed consent form before the trial, and fully understand the content, process and possible adverse reactions of the trial.
Exclusion criteria
Exclusion criteria: Volunteers meeting one or more of the following criteria will be excluded: 1) Prior allergy to docetaxel injection, similar drugs, or Tween-80; or allergy to dexamethasone and adrenocorticotropic hormone analogues; 2) Consumption of strong tea, coffee and/or caffeinated beverages in excess of 1L per day within 3 months prior to screening, and ingestion of chocolate or any caffeinated, theophylline, theobromine, or alcoholic food or beverage within 48h prior to study drug administration; 3) those who have consumed special diets (including grapefruit, etc.) and products with related fruit ingredients within 48h prior to study administration; 4) those who have failed previous treatment with docetaxel (except those who have progressed more than 6 months after docetaxel application); 5) Patients with known brain metastases (except those without brain symptoms or with brain metastases stabilised by radiotherapy); 6) Patients with hepatic impairment: a) Total bilirubin > upper limit of normal (ULN); b) aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 1.5 x ULN combined with alkaline phosphatase > 2.5 x ULN, and aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3.5 x ULN combined with alkaline phosphatase > 6 x ULN in patients with liver metastases, who, in the judgement of the Investigator, are not suitable for trial participation ; 7) Patients with the presence of any severe and/or uncontrolled disease: a) Patients with poorly controlled blood pressure (systolic = 160 mmHg or diastolic = 100 mmHg); b) Patients with grade 2 or greater myocardial ischaemia or myocardial infarction, cardiac arrhythmias (including QTc (Bazetts' formula) =470ms in men or QTc (Bazetts' formula) =480ms in women) and grade =2 congestive heart failure (New York Heart Association (NYHA) classification); c) Left ventricular ejection fraction (LVEF) 10 mmol/L); h) Patients with pre-existing or current gastrointestinal disorders such as peptic ulcer, ulcerative colitis, combined with complete or incomplete intestinal infarction, or other conditions that may cause gastrointestinal haemorrhage or perforation as determined by the investigator; i) Patients with seizures that require treatment; 8) Use of any drug that induces, inhibits, or is metabolised by cytochrome P450-3A, such as cyclosporine, terfenadine, ketoconazole, erythromycin, and vinpocetine within 30 days prior to the trial; CYP3A4 inhibitors such as itraconazole, clarithromycin, indinavir, carrofazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole (except for those drugs that are regularly and steadily applied, as assessed by the investigator). except for those drugs that have been assessed by the investigator to be used on a consistent basis); 9) Acute illness or use of concomitant medication for a new disease that occurs between the Screening Phase and the time of study dosing and is judged by the Investigator to be unsuitable for participation in the trial; 10) Participation in a clinical trial of another drug within 4 weeks prior to the first dose (calculated as the time of the last use of the experimental drug); 11) Pregnant or lactating wo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood concentration;PK parameters;AUC0-t; | — |
Countries
China
Contacts
Public ContactGuoping Yang, Ke Cao
Clinical Trial Center of the Third Xiangya Hospital of Central South University
Outcome results
None listed