A Phase II Study of Anlotinib in STS Patients
Mots clés
Abstrait
Rendez-vous
| Dernière vérification: | 04/30/2019 |
| Première soumission: | 05/29/2013 |
| Inscription estimée soumise: | 06/11/2013 |
| Première publication: | 06/16/2013 |
| Dernière mise à jour soumise: | 05/19/2019 |
| Dernière mise à jour publiée: | 05/21/2019 |
| Date de début réelle de l'étude: | 03/31/2013 |
| Date d'achèvement primaire estimée: | 09/30/2015 |
| Date estimée d'achèvement de l'étude: | 04/29/2017 |
Condition ou maladie
Intervention / traitement
Drug: Anlotinib
Phase
Groupes d'armes
| Bras | Intervention / traitement |
|---|---|
| Experimental: Anlotinib | Drug: Anlotinib |
Critère d'éligibilité
| Âges éligibles aux études | 18 Years À 18 Years |
| Sexes éligibles à l'étude | All |
| Accepte les bénévoles en santé | Oui |
| Critères | Inclusion Criteria: - 1.Faild in introditional treatmeat, Mainly includes:MFH/liposarcoma/leiomyosarcoma/SS and others(MPNST/Fibrosarcoma/CCS/ASPS/AS/ES; 2.Receiveed at least one chemotherapy regimens treatment; 3.18-70years, ECOG:0-2,Expected survival period >3 months; 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.Used contraceptive during the study and after 6 months; 6.Volunteer. Exclusion Criteria: - 1. Received vascular endothelial growth inhibitor type of targeted therapy; 2.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.AE>1 6.Has influence of oral drugs; 7.Brain metastases, spinal cord compression, cancerous meningitis; 8.Any serious or failed to control the disease 9.Artery/venous thrombotic; 10.Coagulant function abnormality; 11.Arteriovenous thrombosis event; 12.Hitory of psychiatric drugs abuse or a mental disorder; 13.Immunodeficiency history; 14.Concomitant diseases. |
Résultat
Mesures des résultats primaires
1. tumor size [each 42 days up to 48 months]
Mesures des résultats secondaires
1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [each 21 days up to 48 months]
