Advanced solid tumor
Conditions
Interventions
Total:Allitinib 400mg, 800mg, 1200mg, 1600mg, 2000mg or 2400mg, orally taken once daily or twice daily consecutively until meeting the withdrawal criteria
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male and female (each proportion should not be less than 1/3) aged 18 to 70 years old; 2. Patients who have histologically or cytologically confirmed advanced solid tumors (breast cancer, lung cancer, ovarian cancer and gastric cancer are preferred) and have failed standard effective therapy or have a diagnosis for which no standard effective treatment is available; 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2; 4. Life expectancy greater than 3 months; 5. Patients with measurable tumor lesions (brain metastatic lesion can not be the exclusive measurable one) according to Response Evaluation Criteria in Solid Tumors (RECIST); 6. Adequate hepatic, renal, and bone marrow function (total bilirubin =1.5*10^9/L, platelet count >=80*10^9/L, hemoglobin >=90g/L); 7. No previous radiation therapy, chemotherapy, targeted therapy, endocrine therapy, or immunotherapy within 4 weeks before treatment with Allitinib; 8. Able and willing to provide signed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant or nursing women or those unwilling to using adequate birth control; 2. Acataposis or gastrointestinal malabsorption; 3. History of prolonged QT interval with clinic significance, ventricular tachycardia, ventricular fibrillation, heart block, heart infarction within 1 year, congestive cardiac failure or symptomatic coronary heart disease needing drug treatment; 4. Patients have a class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; 5. Left ventricular ejection fraction (LVEF) <40%; 6. Active bleeding, new thrombosis disease or taking anticoagulant drugs; 7. Active infection; 8. Surgery of main organ within 6 weeks before study entry; 9. Symptomatic or unstable brain metastasis; 10. Patients with mental aberration or unable to provide signed consent; 11. History of drug or alcohol abuse and affect the evaluation on the results; 12. Having participated in other drug's clinical study; 13. Subjects are thought unsuitable for the study by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximamum tolerate dose;Pharmacokinetic parameters include Cmax, Tmax, Cmin, Ke, T1/2, AUCss, AUCO-8, Cav, CLss/F, Vss/F, PTF, Ra; | — |
Countries
China
Contacts
Public ContactJunning Cao, Jin Li
Outcome results
None listed