Phase II Study of Anlotinib in Patients With Advanced Non-small Cell Lung Cancer（ALTER0302）

Non-small Cell Lung Cancer Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study of Anlotinib(AL3818) as Third Line Treatment in Patients With Advanced Non-small Cell Lung Cancer（ALTER0302）

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01924195
• Other study ID #: ALTN-03-II
• Status: Completed
• Phase: Phase 2
• First received: August 12, 2013
• Last updated: October 27, 2015
• Start date: August 2013
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Anlotibib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit. It has the obvious resistance to new angiogenesis. The trial is to explore Anlotinib for the effectiveness and safety of andvanced non-small cell lung cancer who failed two lines of chemotherapy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: October 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. pathology diagnosed with advanced NSCL with measurable lesions;

2. Have failed for 2 lines of chemotherapy;

3. 18-70years,ECOG PS:0-2,Life expectancy of more than 3 months;

4. Other cytotoxic drugs,radiation therapy,or surgery=4 weeks;

5. main organs function is normal;

6. must be agreed to take contraceptive measures during the study and within 6 months after end.

Exclusion Criteria:

1. SCLC(including mixed with NSCLC);

2. the central cavity of Squamous cell carcinoma and hemoptysis with NSCLC;

3. patients failed to use the anti-tumor angiogenesis therapy;

4. patients has many influence factors toward oral medications ;

5. Brain metastases patients accompanied by symptoms or symptom control for less than two months;

6. patients with severe and failed to controlled diseases,including: suboptimal blood pressure control;suffering from myocardial ischemia or above grade I myocardial infarction, arrhythmias and Class I heart failure;activity or failure to control severe infections;liver disease such as cirrhosis, decompensated liver disease, chronic active hepatitis;poorly controlled diabetes (FBG)>10mmol/L);urine protein=++,etc.

7. patients failed to heal wounds or fractures for Long-term;

8. 4 weeks before enrollment, patients appeared NCI CTC AE grading >1 pulmonary hemorrhage; 4 weeks before enrollment, patients who appeared NCI CTC AE grade> 2 have other parts of the bleeding; patients has a tendency to bleed (eg active peptic ulcer) or are receiving thrombolytic or anticoagulant therapy such as warfarin, heparin or its analogues;

9. patients occurred venous thromboembolic events within 6 months;

10. patients has HIV-positive or organ transplantation;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Anlotinib
Anlotinib QD po.
• Placebo capsule
Placebo QD po.

Locations

Country	Name	City	State
China	Beijing chest hospital,capital medical university	Beijing	Beijing
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing
China	Jilin province tumor hospital	Changchun	Jilin
China	Hunan Province Tumor Hospital	Changsha	Hunan
China	West China Hospital,Sichuan University	Chengdu	Sichuan
China	Xinqiao Hospital, Third Military Medical University	Chongqing	Chongqing
China	The first affiliated hospital,zhejiang university	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Shandong Province Tumor Hospital	Jinan	Shandong
China	Chest hospital affiliated to Shanghai jiaotong university	Shanghai	Shanghai
China	Shanghai Changhai Hospital	Shanghai	Shanghai
China	The First Affiliated Hospital of Suzhou University	Suzhou	Jiangsu
China	Tianjin Medical University Cancer Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	enhanced CT/MRI scan	To evaluate the effectiveness of Anlotinib Hydrochloric Capsule by enhanced CT/MRI scan every two cycles. Refer to recist 1.1.	each 42 days up to disease progression	No
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	contain Serious Adverse Event To evaluate the safety of Anlotinib by CTC AE 4.0	each 21 days up to intolerance the toxicity(or PD)	Yes