A Phase II Study of Anlotinib in MTC Patients
Parole chiave
Astratto
Date
| Ultimo verificato: | 04/30/2019 |
| Primo inviato: | 05/29/2013 |
| Iscrizione stimata inviata: | 06/06/2013 |
| Primo pubblicato: | 06/10/2013 |
| Ultimo aggiornamento inviato: | 05/19/2019 |
| Ultimo aggiornamento pubblicato: | 05/20/2019 |
| Data di inizio effettiva dello studio: | 03/31/2013 |
| Data di completamento primaria stimata: | 11/30/2016 |
| Data stimata di completamento dello studio: | 11/30/2016 |
Condizione o malattia
Intervento / trattamento
Drug: Anlotinib
Fase
Gruppi di braccia
| Braccio | Intervento / trattamento |
|---|---|
| Experimental: Anlotinib | Drug: Anlotinib |
Criteri di idoneità
| Età idonea per lo studio | 18 Years Per 18 Years |
| Sessi idonei allo studio | All |
| Accetta volontari sani | sì |
| Criteri | 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. |
Risultato
Misure di esito primarie
1. enhanced CT scan [each 42 days up to 48 months]
Misure di esito secondarie
1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [each 21 days up to up to 48 months]
