A Phase I Study of Anlotinib on Tolerance and Pharmacokinetics
- Registration Number
- NCT01833923
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
- late malignant tumor patients diagnosed with the pathological and/or cytological;
- lack of the standard treatment or treatment failure;
- 18-65years, ECOG:0-1,Expected survival period >3 months;
- stop medicine > 30 days if any other chemotherapy drugs be used.
- 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.
- 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.
- Volunteer, informed consent form (ICF) signed, compliance.
- Subject was diagnosed with other malignant tumors previously or meanwhile;
- Participated in other clinical trials in four weeks;
- Has influence of oral drugs(such as unable to swallow, gastrointestinal tract after resection);
- Already diagnosed with brain metastases, spinal cord compression, cancerous meningitis, or screening CT or MRI findings of the brain or soft meningeal disease patient;
- Hypertension
- Urine protein: ++, and urinary in 24 hours > 1.0g;
- Coagulant function abnormality: subject with bleeding tendency (such as active peptic ulcer) or are receiving thrombolysis or anticoagulant therapy;
- Subject with psychiatric drugs abuse history and can't get rid of, or mental disorder;
- With artery/venous thrombotic before oral ALTN;
- With history of anticoagulant, vitamin K antagonists(such as warfarin or heparin) or other analogues treatment;
- With Abnormal thyroid function;
- With history of psychiatric drugs abuse or a mental disorder;
- Viral hepatitis B or hepatitis c patients (including hepatitis b, hepatitis c virus carriers);
- Have immunodeficiency history;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description anlotinib anlotinib dosage form:capsule dosage:5mg,10mg,16mg,12mg frequency:once one day duration:Continuous two weeks then stop a week
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China