Study of Anlotinib in Patients With Gastric Cancer(ALTER0503)

Gastric Cancer Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02461407
• Other study ID #: ALTN-05-II
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: June 1, 2015
• Last updated: December 27, 2017
• Start date: June 2015
• Est. completion date: December 2017

Study information

• Verified date: August 2017
• Source: Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
• Contact: Ruihua Xu, Doctor
• Email: xurh[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 378
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Anlotinib
Anlotinib p.o. qd
• Placebo
Placebo p.o. qd

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	The 307th Hospital of Chinese People's Liberation Army	Beijing	Beijing
China	Jilin Cancer Hospital	Changchun	Jilin
China	Hunan Province Tumor Hospital	Changsha	Hunan
China	The Third Xiangya Hospital Central South University	Changsha	Hunan
China	Xiangya Hospital Central South University	Changsha	Hunan
China	The First People's Hospital of Changzhou	Changzhou	Jiangsu
China	Chongqing Daping Hospital	Chongqing	Chongqing
China	Fujian Cancer Hospital	Fuzhou	Fujian
China	Union Hospital of Fujian Medical University	Fuzhou	Fujian
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital School of Medical,Zhejiang University	Hangzhou	Zhejiang
China	Harbin medical university affiliated tumor hospita	Harbin	Heilongjiang
China	The First Affiliated Hospital, Anhui Medical University	Hefei	Anhui
China	The General Hospital of Nanhua University	Hengyang	Hunan
China	Shandong Tumor Hospital	Jinan	Shandong
China	Yunnan Province Tumor Hospital	Kunming	Yunnan
China	Lanzhou General Hospital	Lanzhou	Gansu
China	Linyi City Tumor Hospita	Linyi	Shandong
China	Henan Province Tumor Hospital	Luoyan	Henan
China	Jiangxi Cancer Hospital	Nanchang	Jiangxi
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Jiangsu Cancer Hospital	Nanjing	Jiangsu
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	The People's Hospital of Guangxi Zhuang Autonomous Region	Nanning	Guangxi
China	Nantong Cancer Hospital	Nantong	Jiangsu
China	Cancer Hospital of Fudan University	Shanghai	Shanghai
China	Fudan University Zhongshan Hospital	Shanghai	Shanghai
China	Shanghai General Hospital	Shanghai	Shanghai
China	Liaoning Province Tumor Hospital	Shenyang	Liaoning
China	Fourth Hospital of Hebei Medical University Tumor Hospital of Hebei Province	Shijiazhuang	Hebei
China	Tianjin Medical University Cancer Hospital	Tianjin	Tianjin
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	Tongji Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan	Hubei
China	Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan	Hubei
China	Tangdu Hospital of The fourth Military Medical University	Xian	Shanxi
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)		From randomization until death (up to 24 months)
Secondary	Progress free survival (PFS)		each 42 days up to PD or death(up to 24 months)
Secondary	Objective Response Rate (ORR)		each 42 days up to intolerance the toxicity or PD (up to 24 months)
Secondary	Disease Control Rate (DCR)		each 42 days up to intolerance the toxicity or PD (up to 24 months)