Clinical trial NCT02461407: Study of Anlotinib in Patients With Gastric Cancer(ALTER0503)
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial to Compare the Efficacy and Safety of Anlotinib Versus Placebo in Patients With Gastric Cancer(ALTER0503)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Gastric Cancer
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-06-03
Enrollment: 378
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effects and safety of Anlotinib with placebo in patients with Gastric Cancer.


Eligibility criteria: Inclusion Criteria:

1. Signed and dated informed consent;
2. Pathologically confirmed advanced gastric adenocarcinoma (including Gastroesophageal junction adenocarcinoma) with measurable lesions outside stomach (RECIST 1.1)
3. Advanced stomach cancer patients who have failed to the second line or higher line chemotherapy treatment
4. \>=18 years old；ECOG PS：0\~1；Estimated life expectancy \>3 months
5. Main organs function is normal;

Exclusion Criteria:

1. Patients who have been treated with anlotinib previously;
2. Patients who have been treated with other VEGFR-TKI small-molecule drugs previously, such as sunitinib, Sorafenib, famitinib, Apatinib, Regorafenib, ect
3. Patients suffering from other malignancies currently or within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancers and superficial bladder cancer \[ Ta (non-invasive carcinoma), Tis (carcinoma in situ) and T1 (carcinoma invasion into lamina propria) \]
4. Systemic anti-cancer therapy scheduled 4 weeks prior to assignment or during this study，including cytotoxic therapy，signal transduction inhibitors，immunotherapy(or received mitomycin C within 6 weeks before this study). Extended field radiotherapy(EF-RT) used within 4 weeks prior to assignment or limited field radiotherapy used to assess tumor lesions within 2 weeks prior to assignment;
5. CTCAE(4.0) Grade 1 or higher non-remission toxicity induced by any other previous treatments，excluding alopecia and Grade 2 or lower neurotoxicity induced by oxaliplatin;
6. Patients with a clear tendency of gastrointestinal bleeding;
7. Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea etc.)
8. Patients with pleural effusion or ascites, causing respiratory syndrome (CTCAE Grade 2 or higher dyspnea \[Grade 2 dyspnea refers to Shortness of breath with a small amount of activities, affecting Instrumental activities of daily life\])
9. Patients with any severe and/or unable to control diseases;
10. Patients underwent major surgical treatment，open biopsy or significant traumatic injury within 28 days prior to assignment;
11. Patients with any physical signs of bleeding diathesis or medical history, no matter how serious degree they are; Patients with any CTCAE Grade 3 or higher bleeding events occurred within 4 weeks prior to assignment; Patients with non-healing wounds，ulcers or fractures;
12. Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism;
13. Patients with drug abuse history and unable to get rid of or Patients with mental disorders
14. Brain metastases patients with symptoms or symptoms controlled \< 2 months;
15. Patients participated in other anticancer drug clinical trials within 4 weeks or Patients participating in other clinical trials now;

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: From randomization until death (up to 24 months)
Secondary outcomes:
measure: Progress free survival (PFS)
timeFrame: each 42 days up to PD or death(up to 24 months)
measure: Objective Response Rate (ORR)
timeFrame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
measure: Disease Control Rate (DCR)
timeFrame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital, Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: The 307th Hospital of Chinese People's Liberation Army
state: Beijing
city: Chongqing
country: China
facility: Chongqing Daping Hospital
state: Chongqing
city: Fuzhou
country: China
facility: Union Hospital of Fujian Medical University
state: Fujian
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Lanzhou
country: China
facility: Lanzhou General Hospital
state: Gansu
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Nanning
country: China
facility: The People's Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi
city: Shijiazhuang
country: China
facility: Fourth Hospital of Hebei Medical University Tumor Hospital of Hebei Province
state: Hebei
city: Harbin
country: China
facility: Harbin medical university affiliated tumor hospita
state: Heilongjiang
city: Luoyan
country: China
facility: Henan Province Tumor Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Changsha
country: China
facility: The Third Xiangya Hospital Central South University
state: Hunan
city: Changsha
country: China
facility: Hunan Province Tumor Hospital
state: Hunan
city: Hengyang
country: China
facility: The General Hospital of Nanhua University
state: Hunan
city: Changzhou
country: China
facility: The First People's Hospital of Changzhou
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Nantong
country: China
facility: Nantong Cancer Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital
state: Jiangxi
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Shenyang
country: China
facility: Liaoning Province Tumor Hospital
state: Liaoning
city: Jinan
country: China
facility: Shandong Tumor Hospital
state: Shandong
city: Linyi
country: China
facility: Linyi City Tumor Hospita
state: Shandong
city: Shanghai
country: China
facility: Fudan University Zhongshan Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
city: Shanghai
country: China
facility: Cancer Hospital of Fudan University
state: Shanghai
city: Xian
country: China
facility: Tangdu Hospital of The fourth Military Medical University
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Kunming
country: China
facility: Yunnan Province Tumor Hospital
state: Yunnan
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital School of Medical,Zhejiang University
state: Zhejiang
Study officials:
References: