A Phase II Study of Anlotinib in MTC Patients

Phase 2

Completed

• Conditions: Tumor
• Interventions: Drug: Anlotinib

• Registration Number: NCT01874873
• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-05-30
• Study First Submitted QC: 2013-06-07
• Study First Posted: 2013-06-11
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-20
• Last Update Posted: 2019-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Anlotinib	Anlotinib	-

Primary Outcome Measures

Name	Time	Method
enhanced CT scan	each 42 days up to 48 months

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	each 21 days up to up to 48 months

Trial Locations

Locations (10)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China

The first hospital affiliated to fujian medical university; 🇨🇳 Fuzhou, Fujian, China

Gansu Province Tumor Hospital; 🇨🇳 Lanzhou, Gansu, China

Sun Yat-Sen University Cancer Center; 🇨🇳 Guozhou, Guangdong, China

Harbin medical university affiliated tumor hospital; 🇨🇳 Harbin, Heilongjiang, China

Cancer Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

Jiangsu province tumor hospital; 🇨🇳 Nanjing, Jiangsu, China

Tianjin Medical University Cancer Hospital; 🇨🇳 Tianjin, Tianjin, China

Liaoning Province Tumor Hospital; 🇨🇳 Shenyang, Liaoning, China