A Phase II Study of Anlotinib in MTC Patients (ALTN/MTC)

Phase 2 Study of Anlotinib in Advanced Medullary Thyroid Carcinoma

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.

Study Overview

• Status: Completed
• Conditions: Tumor
• Intervention / Treatment: Drug: Anlotinib

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Peking Union Medical College Hospital
    • Beijing, Beijing, China, 100021
      • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • Fujian
    • Fuzhou, Fujian, China
      • The first hospital affiliated to fujian medical university
  • Gansu
    • Lanzhou, Gansu, China
      • Gansu Province Tumor Hospital
  • Guangdong
    • Guozhou, Guangdong, China
      • Sun yat-sen University Cancer Center
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • Harbin medical university affiliated tumor hospital
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Jiangsu Province Tumor Hospital
  • Liaoning
    • Shenyang, Liaoning, China
      • Liaoning Province Tumor Hospital
  • Shanghai
    • Shanghai, Shanghai, China
      • Cancer Hospital of Fudan University
  • Tianjin
    • Tianjin, Tianjin, China
      • Tianjin Medical University Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anlotinib	Drug: Anlotinib; Other Names: ALTN

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
enhanced CT scan	each 42 days up to 48 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Investigators: Principal Investigator: Jinwan Wang, doctor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Principal Investigator: Pingzhang Tang, doctor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2013
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: May 30, 2013
• First Submitted That Met QC Criteria: June 7, 2013
• First Posted (Estimate): June 11, 2013

Study Record Updates

• Last Update Posted (Actual): May 21, 2019
• Last Update Submitted That Met QC Criteria: May 20, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: ALTN-01-IIA