This trial is active, not recruiting.

Condition tumor
Treatment anlotinib
Phase phase 2
Target VEGF
Sponsor Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
Start date April 2013
End date December 2016
Trial size 47 participants
Trial identifier NCT01874873, ALTN-01-IIA


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 inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2 and VEGFR3. It has the obvious resistance to new angiogenesis. The trial is to explore ALTN for the effectiveness of advanced medullary thyroid carcinoma and security.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
anlotinib ALTN

Primary Outcomes

enhanced CT scan
time frame: each 42 days up to 48 months

Secondary Outcomes

Number of Participants with Adverse Events as a Measure of Safety and Tolerability
time frame: each 21 days up to up to 48 months

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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.

Additional Information

Official title Phase 2 Study of Anlotinib in Advanced Medullary Thyroid Carcinoma
Principal investigator Jinwan Wang, doctor
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd.