Status:
COMPLETED
A Phase II Study of Anlotinib in MTC Patients
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Tumor
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 inhi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT01874873
Start Date
April 1 2013
End Date
December 1 2016
Last Update
May 21 2019
Active Locations (10)
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1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
2
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
3
The first hospital affiliated to fujian medical university
Fuzhou, Fujian, China
4
Gansu Province Tumor Hospital
Lanzhou, Gansu, China