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OpenTrials
Completed

NCT Number: NCT01874873

A Phase II Study of Anlotinib in MTC Patients

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.

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Key information

Conditions

Tumor Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anlotinib

Drug

Other names: ALTN

Primary outcomes

  1. enhanced CT scan

    Time frame: each 42 days up to 48 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Industry

Registry information

Official study title

Phase 2 Study of Anlotinib in Advanced Medullary Thyroid Carcinoma

Acronym: ALTN/MTC

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 11, 2013
Registry last updated
May 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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