Phase II Study of Anlotinib in Patients With Advanced Renal Cell Carcinoma That Have Failed Or Are Intolerant To TKIs Therapy
A Phase II Study of Anlotinib(AL3818) in Patients With Advanced Renal Cell Carcinoma(RCC) That Have Failed Or Are Intolerant To TKIs Therapy
1 other identifier
interventional
60
1 country
15
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 the efficacy and safety profile of Anlotinib in patients with advanced Renal Cell Carcinoma(RCC) that have failed to TKIs therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2013
Typical duration for phase_2
15 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
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 20, 2014
CompletedFirst Posted
Study publicly available on registry
February 26, 2014
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
4 years
January 20, 2014
December 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progress Free Survival (PFS)
The PFS time is defined as time from randomization to locoregional or systemic recurrence, second malignancy or death due to any cause; censored observations will be the last date of: "death", "last tumor assessment", "last follow up date" or "last date in drug log"
each 42 days up to PD or death (up to 36 months)
Secondary Outcomes (3)
Objective Response Rate
each 42 days up to intolerance the toxicity or PD (up to 36 months)
Disease Control Rate (DCR)
each 42 days up to intolerance the toxicity or PD (up to 36 months)
Overall Survival (OS)
From randomization until death (up to 36 months)
Study Arms (1)
Anlotinib
EXPERIMENTALAnlotinib 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:
- Patients with histologically confirmed advanced renal cell carcinoma including clear cell component and not available for surgery
- Previously Failed Or Are Intolerant To TKIs Therapy(such as sunitinib, Sorafenib)
- With measurable disease (using RECIST1.1)
- years,ECOG PS:0-1,Life expectancy of more than 3 months
- Last TKIs Therapy≥4 weeks
- Main organs function is normal
- Signed and dated informed consent
You may not qualify if:
- patients has many influence factors toward oral medications
- Known brain metastases
- 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
- patients occurred venous thromboembolic events within 6 months
- patients has HIV-positive or organ transplantation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100005, China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 404100, China
Gansu Province Tumor Hospital
Lanzhou, Gansu, 730050, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510000, China
Guangxi medical university affiliated tumor hospital
Nanning, Guangxi, 530021, China
Harbin medical university affiliated tumor hospital
Haerbin, Heilongjiang, 150000, China
The 81st Hospital of Chinese PLA
Nanjing, Jiangsu, 210000, China
Jilin Cancer Hospital
Changchun, Jilin, 132000, China
China General Hospital of Shenyang Military Region
Shenyang, Liaoning, 110000, China
Liaoning Province Tumor Hospital
Shenyang, Liaoning, 110042, China
Qilu Hospital，Shandong University
Jinan, Shandong, 250012, China
Cancer Hospital of Fudan University
Shanghai, Shanghai Municipality, 200000, China
West China Hospital，Sichuan University
Chengdu, Sichuan, 610041, China
Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality, 300000, China
Related Publications (1)
Ma J, Song Y, Shou J, Bai Y, Li H, Xie X, Luo H, Ren X, Liu J, Ye D, Bai X, Fu C, Qin S, Wang J, Zhou AP. Anlotinib for Patients With Metastatic Renal Cell Carcinoma Previously Treated With One Vascular Endothelial Growth Factor Receptor-Tyrosine Kinase Inhibitor: A Phase 2 Trial. Front Oncol. 2020 May 7;10:664. doi: 10.3389/fonc.2020.00664. eCollection 2020.
PMID: 32457838DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2014
First Posted
February 26, 2014
Study Start
December 1, 2013
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
December 29, 2017
Record last verified: 2017-08