Clinical trial NCT01924195: Phase II Study of Anlotinib in Patients With Advanced Non-small Cell Lung Cancer（ALTER0302）
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）
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: lung
Anlotinib
AL3818
NSCLC
Cancer
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-08-16
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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;

Primary outcomes:
measure: enhanced CT/MRI scan
timeFrame: each 42 days up to disease progression
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: each 21 days up to intolerance the toxicity(or PD)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Beijing chest hospital，capital medical university
state: Beijing
city: Chongqing
country: China
facility: Xinqiao Hospital, Third Military Medical University
state: Chongqing
city: Changsha
country: China
facility: Hunan Province Tumor Hospital
state: Hunan
city: Suzhou
country: China
facility: The First Affiliated Hospital of Suzhou University
state: Jiangsu
city: Changchun
country: China
facility: Jilin province tumor hospital
state: Jilin
city: Jinan
country: China
facility: Shandong Province Tumor Hospital
state: Shandong
city: Shanghai
country: China
facility: Chest hospital affiliated to Shanghai jiaotong university
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Changhai Hospital
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital,Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: The first affiliated hospital,zhejiang university
state: Zhejiang
Study officials:
affiliation: Chest hospital affiliated to Shanghai jiaotong university
name: Bao hui Han, doctor
role: PRINCIPAL_INVESTIGATOR
References: