A Phase II Study of Anlotinib in MTC Patients

NCT01874873 | Completed Phase 2 DMC

• 1 other identifier: ALTN-01-IIA
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 10

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.

Conditions

Tumor

Outcome Measures

Primary Outcomes (1)

• enhanced CT scan

  each 42 days up to 48 months

Secondary Outcomes (1)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  each 21 days up to up to 48 months

Study Arms (1)

Anlotinib

EXPERIMENTAL

Drug: Anlotinib

Interventions

Anlotinib DRUG

Also known as: ALTN

Anlotinib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• ×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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (10)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

The first hospital affiliated to fujian medical university

Fuzhou, Fujian, China

Location

Gansu Province Tumor Hospital

Lanzhou, Gansu, China

Location

Sun Yat-Sen University Cancer Center

Guozhou, Guangdong, China

Location

Harbin medical university affiliated tumor hospital

Harbin, Heilongjiang, China

Location

Jiangsu province tumor hospital

Nanjing, Jiangsu, China

Location

Liaoning Province Tumor Hospital

Shenyang, Liaoning, China

Location

Cancer Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Location

Tianjin Medical University Cancer Hospital

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Conditions

Neoplasms

Interventions

anlotinib

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2013
• First Posted: June 11, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 21, 2019

Record last verified: 2019-05

Locations

CN (10)