Status:
COMPLETED
A Phase I Study of Anlotinib on Tolerance and Pharmacokinetics
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Collaborating Sponsors:
Nanjing Medical University
Conditions:
Advanced Cancer
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 inh...
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 pharmacokineti...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01833923
Start Date
May 1 2011
End Date
October 1 2015
Last Update
October 28 2015
Active Locations (1)
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1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021