A Phase I Study of Anlotinib on Tolerance and Pharmacokinetics
Sleutelwoorden
Abstract
Omschrijving
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.
Datums
| Laatst geverifieerd: | 09/30/2015 |
| Eerste ingediend: | 03/28/2013 |
| Geschatte inschrijving ingediend: | 04/12/2013 |
| Eerst geplaatst: | 04/16/2013 |
| Laatste update ingediend: | 10/26/2015 |
| Laatste update geplaatst: | 10/27/2015 |
| Werkelijke startdatum van het onderzoek: | 04/30/2011 |
| Geschatte primaire voltooiingsdatum: | 09/30/2015 |
| Geschatte voltooiingsdatum van het onderzoek: | 09/30/2015 |
Conditie of ziekte
Interventie / behandeling
Drug: anlotinib
Fase
Armgroepen
| Arm | Interventie / behandeling |
|---|---|
| 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. |
Geschiktheidscriteria
| Leeftijden die in aanmerking komen voor studie | 18 Years Naar 18 Years |
| Geslachten die in aanmerking komen voor studie | All |
| Accepteert gezonde vrijwilligers | Ja |
| Criteria | 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. |
Resultaat
Primaire uitkomstmaten
1. Tmax Cmax t1/2 AUC [Up to 52 days]
Secundaire uitkomstmaten
1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [Up to 21 days]
Andere uitkomstmaten
1. tumor size [Up to 42 days]
