A Phase II Study of Anlotinib in MTC Patients
Sleutelwoorden
Abstract
Datums
| Laatst geverifieerd: | 04/30/2019 |
| Eerste ingediend: | 05/29/2013 |
| Geschatte inschrijving ingediend: | 06/06/2013 |
| Eerst geplaatst: | 06/10/2013 |
| Laatste update ingediend: | 05/19/2019 |
| Laatste update geplaatst: | 05/20/2019 |
| Werkelijke startdatum van het onderzoek: | 03/31/2013 |
| Geschatte primaire voltooiingsdatum: | 11/30/2016 |
| Geschatte voltooiingsdatum van het onderzoek: | 11/30/2016 |
Conditie of ziekte
Interventie / behandeling
Drug: Anlotinib
Fase
Armgroepen
| Arm | Interventie / behandeling |
|---|---|
| Experimental: Anlotinib | Drug: Anlotinib |
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 medullary thyroid carcinoma; 2.18-70years, ECOG:0-2,Expected survival period >3 months; 3.Calcitonic≥500pg/ml, thyroid function normal; 4.HB≥100g/L,ANC(Absolute Neutrophil Count) ≥1.5×109/L；PLT - 80×109/L ,BIL/Cr in normal range,ALT/AST(aspartate aminotransferase )≤1.5*ULN(for hepatic metastases,ALT/AST(aspartate aminotransferase )≤5*ULN) ;TG≤ 3.0mmol/L，cholesterol≤7.75mmol/L; LVEF - LLN. 5.Username contraceptive during the study and after 6 months; 6.Volunteer. Exclusion Criteria: - 1.Received vascular endothelial growth inhibitor type of targeted therapy; 2.Subject was diagnosed with The second cancer; 3.Participated in other clinical trials in four weeks; 4.Received in other radiotherapy or chemotherapy treatment in four weeks; 5.With AE> 1; 6.Has influence of oral drugs; 7.Brain metastases, spinal cord compression, cancerous meningitis, or the brain/soft meningeal disease patient; 8.Any serious or failed to control the disease 9.Artery/venous thrombotic; 10.Coagulant function abnormality; 11.Arteriovenous thrombosis event; 12.History of psychiatric drugs abuse or a mental disorder; 13.Immunodeficiency history; 14.Concomitant diseases. |
Resultaat
Primaire uitkomstmaten
1. enhanced CT scan [each 42 days up to 48 months]
Secundaire uitkomstmaten
1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [each 21 days up to up to 48 months]
