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A Phase I Study of Anlotinib on Tolerance and Pharmacokinetics

Ní féidir ach le húsáideoirí cláraithe ailt a aistriú
Logáil Isteach / Cláraigh
Sábháiltear an nasc chuig an gearrthaisce
StádasCríochnaithe
Urraitheoirí
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Comhoibritheoirí
Nanjing Medical University

Keywords

Coimriú

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.

Cur síos

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.

Dátaí

Fíoraithe Deireanach: 09/30/2015
Cuireadh isteach den chéad uair: 03/28/2013
Clárú Measta Curtha isteach: 04/12/2013
Arna chur suas ar dtús: 04/16/2013
Nuashonrú Deireanach Curtha isteach: 10/26/2015
Nuashonrú Deireanach Postáilte: 10/27/2015
Dáta Tosaigh an Staidéir Iarbhír: 04/30/2011
Dáta Críochnaithe Bunscoile Measta: 09/30/2015
Dáta Críochnaithe an Staid Mheasta: 09/30/2015

Coinníoll nó galar

Advanced Cancer

Idirghabháil / cóireáil

Drug: anlotinib

Céim

Céim 1

Grúpaí Láimhe

LámhIdirghabháil / cóireáil
Experimental: anlotinib
dosage form:capsule dosage:5mg,10mg,16mg,12mg frequency:once one day duration:Continuous two weeks then stop a week
Drug: anlotinib
oral medicine.

Critéir Incháilitheachta

Aois Incháilithe le haghaidh Staidéir 18 Years Chun 18 Years
Gnéas Incháilithe le haghaidh StaidéirAll
Glacann Oibrithe Deonacha SláintiúlaSea
Critéir

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.

Toradh

Bearta Toraidh Príomhúla

1. 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

Bearta Torthaí Tánaisteacha

1. 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

Bearta Toraidh Eile

1. tumor size [Up to 42 days]

To evaluate the effectiveness of ALTN by enhanced CT scan every two cycles. Refer to recist 1.1.

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