Study of Anlotinib in Patients With Gastric Cancer(ALTER0503)
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)
1 other identifier
interventional
378
1 country
38
Brief Summary
The purpose of this study is to compare the effects and safety of Anlotinib with placebo in patients with Gastric Cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 gastric-cancer
Started Jun 2015
Shorter than P25 for phase_2 gastric-cancer
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedFirst Posted
Study publicly available on registry
June 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedDecember 29, 2017
August 1, 2017
2.5 years
June 1, 2015
December 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
From randomization until death (up to 24 months)
Secondary Outcomes (3)
Progress free survival (PFS)
each 42 days up to PD or death(up to 24 months)
Objective Response Rate (ORR)
each 42 days up to intolerance the toxicity or PD (up to 24 months)
Disease Control Rate (DCR)
each 42 days up to intolerance the toxicity or PD (up to 24 months)
Study Arms (2)
Anlotinib
EXPERIMENTALAnlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Placebo
PLACEBO COMPARATORPlacebo QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Interventions
Eligibility Criteria
You may qualify if:
- Signed and dated informed consent;
- Pathologically confirmed advanced gastric adenocarcinoma (including Gastroesophageal junction adenocarcinoma) with measurable lesions outside stomach (RECIST 1.1)
- Advanced stomach cancer patients who have failed to the second line or higher line chemotherapy treatment
- \>=18 years old；ECOG PS：0\~1；Estimated life expectancy \>3 months
- Main organs function is normal;
You may not qualify if:
- Patients who have been treated with anlotinib previously;
- Patients who have been treated with other VEGFR-TKI small-molecule drugs previously, such as sunitinib, Sorafenib, famitinib, Apatinib, Regorafenib, ect
- 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 \[ Ta (non-invasive carcinoma), Tis (carcinoma in situ) and T1 (carcinoma invasion into lamina propria) \]
- 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;
- 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;
- Patients with a clear tendency of gastrointestinal bleeding;
- Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea etc.)
- Patients with pleural effusion or ascites, causing respiratory syndrome (CTCAE Grade 2 or higher dyspnea \[Grade 2 dyspnea refers to Shortness of breath with a small amount of activities, affecting Instrumental activities of daily life\])
- Patients with any severe and/or unable to control diseases;
- Patients underwent major surgical treatment，open biopsy or significant traumatic injury within 28 days prior to assignment;
- 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;
- 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;
- Patients with drug abuse history and unable to get rid of or Patients with mental disorders
- Brain metastases patients with symptoms or symptoms controlled \< 2 months;
- Patients participated in other anticancer drug clinical trials within 4 weeks or Patients participating in other clinical trials now;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
The First Affiliated Hospital, Anhui Medical University
Hefei, Anhui, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
The 307th Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality, China
Chongqing Daping Hospital
Chongqing, Chongqing Municipality, 400042, China
Union Hospital of Fujian Medical University
Fuzhou, Fujian, 350001, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Lanzhou General Hospital
Lanzhou, Gansu, 730070, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530021, China
Fourth Hospital of Hebei Medical University Tumor Hospital of Hebei Province
Shijiazhuang, Hebei, 050011, China
Harbin medical university affiliated tumor hospita
Harbin, Heilongjiang, China
Henan Province Tumor Hospital
Luoyan, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Xiangya Hospital Central South University
Changsha, Hunan, 410008, China
The Third Xiangya Hospital Central South University
Changsha, Hunan, 410013, China
Hunan Province Tumor Hospital
Changsha, Hunan, China
The General Hospital of Nanhua University
Hengyang, Hunan, 421001, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, 213003, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Nantong Cancer Hospital
Nantong, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
Jilin Cancer Hospital
Changchun, Jilin, 132000, China
Liaoning Province Tumor Hospital
Shenyang, Liaoning, China
Shandong Tumor Hospital
Jinan, Shandong, 250117, China
Linyi City Tumor Hospita
Linyi, Shandong, China
Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080, China
Cancer Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Tangdu Hospital of The fourth Military Medical University
Xian, Shanxi, China
Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Yunnan Province Tumor Hospital
Kunming, Yunnan, China
Sir Run Run Shaw Hospital School of Medical,Zhejiang University
Hangzhou, Zhejiang, 310016, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Shen Lin, Doctor
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2015
First Posted
June 3, 2015
Study Start
June 1, 2015
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
December 29, 2017
Record last verified: 2017-08