A Phase II Study of Anlotinib in MTC Patients

Tumor Clinical Trial

— ALTN/MTC  

Official title:

Phase 2 Study of Anlotinib in Advanced Medullary Thyroid Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01874873
• Other study ID #: ALTN-01-IIA
• Status: Completed
• Phase: Phase 2
• Start date: April 2013
• Est. completion date: December 2016

Study information

• Verified date: May 2019
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tumor

Intervention

Drug:
• Anlotinib

Locations

Country	Name	City	State
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	The first hospital affiliated to fujian medical university	Fuzhou	Fujian
China	Sun Yat-Sen University Cancer Center	Guozhou	Guangdong
China	Harbin medical university affiliated tumor hospital	Harbin	Heilongjiang
China	Gansu Province Tumor Hospital	Lanzhou	Gansu
China	Jiangsu province tumor hospital	Nanjing	Jiangsu
China	Cancer Hospital of Fudan University	Shanghai	Shanghai
China	Liaoning Province Tumor Hospital	Shenyang	Liaoning
China	Tianjin Medical University Cancer Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	enhanced CT scan		each 42 days up to 48 months
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		each 21 days up to up to 48 months