Clinical trial NCT02072044: Phase II Study of Anlotinib in Patients With Advanced Renal Cell Carcinoma That Have Failed Or Are Intolerant To TKIs Therapy
Official title: A Phase II Study of Anlotinib(AL3818) in Patients With Advanced Renal Cell Carcinoma(RCC) That Have Failed Or Are Intolerant To TKIs Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Renal Cell Carcinoma
Keywords: Renal Cell Carcinoma（RCC）
Anlotinib
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-02-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 1.Patients with histologically confirmed advanced renal cell carcinoma including clear cell component and not available for surgery
* 2.Previously Failed Or Are Intolerant To TKIs Therapy(such as sunitinib, Sorafenib)
* 3.With measurable disease (using RECIST1.1)
* 4.18-75years,ECOG PS:0-1,Life expectancy of more than 3 months
* 5.Last TKIs Therapy≥4 weeks
* 6.Main organs function is normal
* 7.Signed and dated informed consent

Exclusion Criteria:

* 1.patients has many influence factors toward oral medications
* 2.Known brain metastases
* 3.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.
* 4.patients failed to heal wounds or fractures for Long-term
* 5.patients occurred venous thromboembolic events within 6 months
* 6.patients has HIV-positive or organ transplantation

Primary outcomes:
measure: Progress Free Survival (PFS)
timeFrame: each 42 days up to PD or death (up to 36 months)
Secondary outcomes:
measure: Objective Response Rate
timeFrame: each 42 days up to intolerance the toxicity or PD (up to 36 months)
measure: Disease Control Rate (DCR)
timeFrame: each 42 days up to intolerance the toxicity or PD (up to 36 months)
measure: Overall Survival (OS)
timeFrame: From randomization until death (up to 36 months)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
state: Chongqing
city: Lanzhou
country: China
facility: Gansu Province Tumor Hospital
state: Gansu
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangdong
city: Nanning
country: China
facility: Guangxi medical university affiliated tumor hospital
state: Guangxi
city: Haerbin
country: China
facility: Harbin medical university affiliated tumor hospital
state: Heilongjiang
city: Nanjing
country: China
facility: The 81st Hospital of Chinese PLA
state: Jiangsu
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Shenyang
country: China
facility: China General Hospital of Shenyang Military Region
state: Liaoning
city: Shenyang
country: China
facility: Liaoning Province Tumor Hospital
state: Liaoning
city: Jinan
country: China
facility: Qilu Hospital，Shandong University
state: Shandong
city: Shanghai
country: China
facility: Cancer Hospital of Fudan University
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital，Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Hospital
state: Tianjin
Study officials:
References:
citation: 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.