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

NCT01924195 | Completed Phase 2 DMC

• 1 other identifier: ALTN-03-II
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 13

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

Keywords

lung; Anlotinib; AL3818; NSCLC; Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

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

  each 21 days up to intolerance the toxicity(or PD)

Study Arms (2)

Anlotinib

ACTIVE COMPARATOR

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

Drug: Anlotinib

Placebo Capsule

PLACEBO COMPARATOR

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

Drug: Placebo capsule

Interventions

Anlotinib DRUG

Anlotinib QD po.

Anlotinib

Placebo capsule DRUG

Placebo QD po.

Placebo Capsule

Eligibility Criteria

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

You may qualify if:

• pathology diagnosed with advanced NSCL with measurable lesions;
• Have failed for 2 lines of chemotherapy;
• years,ECOG PS:0-2,Life expectancy of more than 3 months;
• Other cytotoxic drugs,radiation therapy,or surgery≥4 weeks;
• main organs function is normal;
• must be agreed to take contraceptive measures during the study and within 6 months after end.

You may not qualify if:

• SCLC(including mixed with NSCLC);
• the central cavity of Squamous cell carcinoma and hemoptysis with NSCLC;
• patients failed to use the anti-tumor angiogenesis therapy;
• patients has many influence factors toward oral medications ;
• Brain metastases patients accompanied by symptoms or symptom control for less than two months;
• 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.
• patients failed to heal wounds or fractures for Long-term;
• 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;
• patients occurred venous thromboembolic events within 6 months;
• patients has HIV-positive or organ transplantation;

Sponsors & Collaborators

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

Study Sites (13)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Beijing chest hospital，capital medical university

Beijing, Beijing Municipality, 101149, China

Location

Xinqiao Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400037, China

Location

Hunan Province Tumor Hospital

Changsha, Hunan, 410013, China

Location

The First Affiliated Hospital of Suzhou University

Suzhou, Jiangsu, 215006, China

Location

Jilin province tumor hospital

Changchun, Jilin, 130000, China

Location

Shandong Province Tumor Hospital

Jinan, Shandong, 250117, China

Location

Chest hospital affiliated to Shanghai jiaotong university

Shanghai, Shanghai Municipality, 200000, China

Location

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

West China Hospital,Sichuan University

Chengdu, Sichuan, 610041, China

Location

Tianjin Medical University Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

The first affiliated hospital,zhejiang university

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasms

Interventions

anlotinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Bao hui Han, doctor

  Chest hospital affiliated to Shanghai jiaotong university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2013
• First Posted: August 16, 2013
• Study Start: August 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 28, 2015

Record last verified: 2015-10

Locations

CN (13)