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

NCT ID: NCT01924195

Last Updated: 2015-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2015-10-31

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

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Anlotinib

Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Group Type: ACTIVE_COMPARATOR

Anlotinib

Intervention Type: DRUG

Anlotinib QD po.

Placebo Capsule

Placebo capsule QD po and it should be continued until disease progression or patients withdrawal of consent

Group Type: PLACEBO_COMPARATOR

Placebo capsule

Intervention Type: DRUG

Placebo QD po.

Interventions

Anlotinib

Anlotinib QD po.

Intervention Type: DRUG

Placebo capsule

Placebo QD po.

Intervention Type: DRUG

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bao hui Han, doctor

Role: PRINCIPAL_INVESTIGATOR

Chest hospital affiliated to Shanghai jiaotong university

Locations

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Beijing chest hospital，capital medical university

Beijing, Beijing Municipality, China

Xinqiao Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, China

Hunan Province Tumor Hospital

Changsha, Hunan, China

The First Affiliated Hospital of Suzhou University

Suzhou, Jiangsu, China

Jilin province tumor hospital

Changchun, Jilin, China

Shandong Province Tumor Hospital

Jinan, Shandong, China

Chest hospital affiliated to Shanghai jiaotong university

Shanghai, Shanghai Municipality, China

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, China

West China Hospital,Sichuan University

Chengdu, Sichuan, China

Tianjin Medical University Cancer Hospital

Tianjin, Tianjin Municipality, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

The first affiliated hospital,zhejiang university

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

ALTN-03-II

Identifier Type: -

Identifier Source: org_study_id