Clinical trial NCT01874873: A Phase II Study of Anlotinib in MTC Patients
Official title: Phase 2 Study of Anlotinib in Advanced Medullary Thyroid Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tumor
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-06-11
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: enhanced CT scan
timeFrame: each 42 days up to 48 months
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: each 21 days up to up to 48 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Fuzhou
country: China
facility: The first hospital affiliated to fujian medical university
state: Fujian
city: Lanzhou
country: China
facility: Gansu Province Tumor Hospital
state: Gansu
city: Guozhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangdong
city: Harbin
country: China
facility: Harbin medical university affiliated tumor hospital
state: Heilongjiang
city: Nanjing
country: China
facility: Jiangsu province tumor hospital
state: Jiangsu
city: Shenyang
country: China
facility: Liaoning Province Tumor Hospital
state: Liaoning
city: Shanghai
country: China
facility: Cancer Hospital of Fudan University
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Hospital
state: Tianjin
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Jinwan Wang, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Pingzhang Tang, doctor
role: PRINCIPAL_INVESTIGATOR
References: