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ALTN/MTC: A Phase II Study of Anlotinib in MTC Patients

Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT01874873
Collaborator
(none)
58
Enrollment
10
Locations
1
Arm
44
Actual Duration (Months)
5.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
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 :
Apr 1, 2013
Actual Primary Completion Date :
Dec 1, 2016
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Anlotinib

Drug: Anlotinib
Other Names:
  • ALTN

    		•

    Outcome Measures

    Primary Outcome Measures

    1. enhanced CT scan [each 42 days up to 48 months]

    Secondary Outcome Measures

    1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [each 21 days up to up to 48 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    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 )≤1.5ULN(for hepatic metastases,ALT/AST(aspartate aminotransferase )≤5ULN) ;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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cancer Institute and Hospital, Chinese Academy of Medical Sciences Beijing Beijing China 100021
    2 Peking Union Medical College Hospital Beijing Beijing China
    3 The first hospital affiliated to fujian medical university Fuzhou Fujian China
    4 Gansu Province Tumor Hospital Lanzhou Gansu China
    5 Sun Yat-Sen University Cancer Center Guozhou Guangdong China
    6 Harbin medical university affiliated tumor hospital Harbin Heilongjiang China
    7 Jiangsu province tumor hospital Nanjing Jiangsu China
    8 Liaoning Province Tumor Hospital Shenyang Liaoning China
    9 Cancer Hospital of Fudan University Shanghai Shanghai China
    10 Tianjin Medical University Cancer Hospital Tianjin Tianjin China

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT01874873
    Other Study ID Numbers:
    • ALTN-01-IIA
    First Posted:
    Jun 11, 2013
    Last Update Posted:
    May 21, 2019
    Last Verified:
    May 1, 2019

    Study Results

    No Results Posted as of May 21, 2019