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

Primary Purpose

Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Anlotinib
Placebo capsule
Sponsored by
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring lung, Anlotinib, AL3818, NSCLC, Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • Beijing chest hospital，capital medical university
  • Xinqiao Hospital, Third Military Medical University
  • Hunan Province Tumor Hospital
  • The First Affiliated Hospital of Suzhou University
  • Jilin province tumor hospital
  • Shandong Province Tumor Hospital
  • Chest hospital affiliated to Shanghai jiaotong university
  • Shanghai Changhai Hospital
  • West China Hospital,Sichuan University
  • Tianjin Medical University Cancer Hospital
  • Zhejiang Cancer Hospital
  • The first affiliated hospital,zhejiang university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Anlotinib

Placebo Capsule

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 12, 2013
Last Updated
October 27, 2015
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01924195
Brief Title
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

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
lung, Anlotinib, AL3818, NSCLC, Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anlotinib
Arm Type
Active Comparator
Arm Description
Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Arm Title
Placebo Capsule
Arm Type
Placebo Comparator
Arm Description
Placebo capsule QD po and it should be continued until disease progression or patients withdrawal of consent
Intervention Type
Drug
Intervention Name(s)
Anlotinib
Intervention Description
Anlotinib QD po.
Intervention Type
Drug
Intervention Name(s)
Placebo capsule
Intervention Description
Placebo QD po.
Primary Outcome Measure Information:
Title
enhanced CT/MRI scan
Description
To evaluate the effectiveness of Anlotinib Hydrochloric Capsule by enhanced CT/MRI scan every two cycles. Refer to recist 1.1.
Time Frame
each 42 days up to disease progression
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Description
contain Serious Adverse Event To evaluate the safety of Anlotinib by CTC AE 4.0
Time Frame
each 21 days up to intolerance the toxicity(or PD)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: pathology diagnosed with advanced NSCL with measurable lesions; Have failed for 2 lines of chemotherapy; 18-70years,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. Exclusion Criteria: 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; 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; patients occurred venous thromboembolic events within 6 months; patients has HIV-positive or organ transplantation;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bao hui Han, doctor
Organizational Affiliation
Chest hospital affiliated to Shanghai jiaotong university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Beijing chest hospital，capital medical university
City
Beijing
State/Province
Beijing
ZIP/Postal Code
101149
Country
China
Facility Name
Xinqiao Hospital, Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400037
Country
China
Facility Name
Hunan Province Tumor Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
The First Affiliated Hospital of Suzhou University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Facility Name
Jilin province tumor hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Facility Name
Shandong Province Tumor Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Facility Name
Chest hospital affiliated to Shanghai jiaotong university
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
Shanghai Changhai Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
West China Hospital,Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Tianjin Medical University Cancer Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
The first affiliated hospital,zhejiang university
City
Hangzhou
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

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

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