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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01874873
Recruitment Status : Completed
First Posted : June 11, 2013
Last Update Posted : May 21, 2019
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Tumor Drug: Anlotinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Anlotinib in Advanced Medullary Thyroid Carcinoma
Actual Study Start Date : April 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Anlotinib Drug: Anlotinib
Other Name: ALTN

Primary Outcome Measures :
  1. enhanced CT scan [ Time Frame: each 42 days up to 48 months ]

Secondary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: each 21 days up to up to 48 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01874873

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China, Beijing
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing, China, 100021
Peking Union Medical College Hospital
Beijing, Beijing, China
China, Fujian
The first hospital affiliated to fujian medical university
Fuzhou, Fujian, China
China, Gansu
Gansu Province Tumor Hospital
Lanzhou, Gansu, China
China, Guangdong
Sun Yat-Sen University Cancer Center
Guozhou, Guangdong, China
China, Heilongjiang
Harbin medical university affiliated tumor hospital
Harbin, Heilongjiang, China
China, Jiangsu
Jiangsu province tumor hospital
Nanjing, Jiangsu, China
China, Liaoning
Liaoning Province Tumor Hospital
Shenyang, Liaoning, China
China, Shanghai
Cancer Hospital of Fudan University
Shanghai, Shanghai, China
China, Tianjin
Tianjin Medical University Cancer Hospital
Tianjin, Tianjin, China
Sponsors and Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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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
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Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Identifier: NCT01874873    
Other Study ID Numbers: ALTN-01-IIA
First Posted: June 11, 2013    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019