Advanced Cancer
Conditions
Keywords
Advanced cancer
Brief summary
Anlotibib (ALTN) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. ALTN is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2 and VEGFR3. It has the obvious resistance to new angiogenesis.
Detailed description
The primary objective of this trial is to explore the maximum tolerated dose(MTD), dose-limiting toxicity(DLT) of ALTN and rational dosage regimen for phase II study, to investigate the pharmacokinetics with single and multiple doses of ALTN from 5mg/d,10mg/d,16mg/d,12mg.
Interventions
DRUGanlotinib
oral medicine.
Sponsors
Nanjing Medical University
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. late malignant tumor patients diagnosed with the pathological and/or cytological; 2. lack of the standard treatment or treatment failure; 3. 18-65years, ECOG:0-1,Expected survival period \>3 months; 4. stop medicine \> 30 days if any other chemotherapy drugs be used. 5. HB≥90g/L,ANC(Absolute Neutrophil Count) ≥1.5×109/L；PLT ≥100×109/L ,BIL/ALT/AST(aspartate aminotransferase )/Cr in normal range,or CCR≥60ml/min,TG≤ 3.0mmol/L，cholesterol≤7.75mmol/L; LVEF≥LLN. 6. Female should be agreed to use contraceptive during the study and after 6 months (such as intrauterine device(IUD), the pill or a condom); The serum or urine pregnancy test negative before take ALTN, and is out of non-lactation period. Male should be agreed to use contraceptive during the study and after the period of 6 months. 7. Volunteer, informed consent form (ICF) signed, compliance.
Exclusion criteria
1. Subject was diagnosed with other malignant tumors previously or meanwhile; 2. Participated in other clinical trials in four weeks; 3. Has influence of oral drugs(such as unable to swallow, gastrointestinal tract after resection); 4. Already diagnosed with brain metastases, spinal cord compression, cancerous meningitis, or screening CT or MRI findings of the brain or soft meningeal disease patient; 5. Hypertension 6. Urine protein: ++, and urinary in 24 hours \> 1.0g; 7. Coagulant function abnormality: subject with bleeding tendency (such as active peptic ulcer) or are receiving thrombolysis or anticoagulant therapy; 8. Subject with psychiatric drugs abuse history and can't get rid of, or mental disorder; 9. With artery/venous thrombotic before oral ALTN; 10. With history of anticoagulant, vitamin K antagonists(such as warfarin or heparin) or other analogues treatment; 11. With Abnormal thyroid function; 12. With history of psychiatric drugs abuse or a mental disorder; 13. Viral hepatitis B or hepatitis c patients (including hepatitis b, hepatitis c virus carriers); 14. Have immunodeficiency history; 15. According to the researcher's judgment,there are concomitant diseases which will seriously endanger the patients or obstruct the patients to complete the clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tmax Cmax t1/2 AUC | Up to 52 days | To collect point with single drug:H0/H0.5/H1/H2/H4/H8/H12/H24/H48/H72/H96/H120/H144/H/H168/H192/H216/H240 To collect point with multiple drug:d1/d2/d4/d7/d10/d14/d15/d21/d22/d28/d35/d42 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Up to 21 days | blood examination, urine examination, stool examination, blood biochemical (ALT, AST, TB(total bilirubin), DB, BUN, Cr, blood electrolyte), electrocardiogram (ecg), thyroid function, the function of blood coagulation, etc |
Other
| Measure | Time frame | Description |
|---|---|---|
| tumor size | Up to 42 days | To evaluate the effectiveness of ALTN by enhanced CT scan every two cycles. Refer to recist 1.1. |
Countries
China
Outcome results
None listed