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Phase 2 Study of Anlotinib Hydrochloric Capsule in Advanced Medullary Thyroid Carcinoma


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Tumor

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Trial Information

Phase 2 Study of Anlotinib Hydrochloric Capsule in Advanced Medullary Thyroid Carcinoma


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

enhanced CT scan

Outcome Time Frame:

each 42 days up to 48 months

Safety Issue:

No

Principal Investigator

Jinwan Wang, doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Authority:

China: Food and Drug Administration

Study ID:

ALTN-01-IIA

NCT ID:

NCT01874873

Start Date:

April 2013

Completion Date:

June 2014

Related Keywords:

  • Tumor

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