Phase II Study of Anlotinib Versus Sunitinib in Patients With Advanced Renal Cell Carcinoma（RCC）

Anlotinib Clinical Trial

Official title:

A Randomized, Positive-controlled, Multicenter, Phase II Study of Anlotinib(AL3818) in Patients With Advanced Renal Cell Carcinoma(RCC)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02072031
• Other study ID #: ALTN-06-IIA
• Status: Active, not recruiting
• Phase: Phase 2
• First received: January 20, 2014
• Last updated: April 25, 2016
• Start date: December 2013
• Est. completion date: December 2016

Study information

• Verified date: April 2016
• Source: Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationChina: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 compare the efficacy and safety profile between Anlotinib and Sunitinib in patients with advanced Renal Cell Carcinoma(RCC).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 133
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 1.Patients with histologically confirmed advanced renal cell carcinoma including clear cell component and not available for surgery

• 2.Without drug treatment for RCC or chemotherapy/cytokine therapy failure or resistant patients)

• 3.With measurable disease (using RECIST1.1)

• 4.18-75years,ECOG PS:0-1,Life expectancy of more than 3 months

• 5.Other cytotoxic drugs,radiation therapy,or surgery=4 weeks

• 6.main organs function is normal

• 7.Signed and dated informed consent

Exclusion Criteria:

• 1.Previously received targeted therapy of the metastatic renal cell carcinoma (such as sunitinib, Sorafenib)

• 2.patients has many influence factors toward oral medications

• 3.Known brain metastases

• 4.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.

• 5.patients failed to heal wounds or fractures for Long-term

• 6.patients occurred venous thromboembolic events within 6 months

• 7.patients has HIV-positive or organ transplantation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anlotinib
• Carcinoma, Renal Cell
• RCC

Intervention

Drug:
• Anlotinib
Anlotinib p.o. qd
• Sunitinib maleate
Sunitinib 50 mg p.o. qd

Locations

Country	Name	City	State
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Jilin Cancer Hospital	Changchun	Jilin
China	West China Hospital,Sichuan University	Chengdu	Sichuan
China	Chongqing Cancer Hospital	Chongqing	Chongqing
China	Sun Yat-Sen University Cancer Center	Guangzhou	Guangdong
China	Harbin medical university affiliated tumor hospital	Haerbin	Heilongjiang
China	Qilu Hospital,Shandong University	Jinan	Shandong
China	Gansu Province Tumor Hospital	Lanzhou	Gansu
China	The 81st Hospital of Chinese PLA	Nanjing	Jiangsu
China	Guangxi medical university affiliated tumor hospital	Nanning	Guangxi
China	Cancer Hospital of Fudan University	Shanghai	Shanghai
China	China General Hospital of Shenyang Military Region	Shenyang	Liaoning
China	Liaoning Province Tumor Hospital	Shenyang	Liaoning
China	Tianjin Medical University Cancer Hospital	Tianjin	Tianjin

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	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)	No
Secondary	Objective Response Rate	To evaluate the effectiveness of Anlotinib Hydrochloric Capsule by enhanced CT/MRI scan every two cycles or Sunitinib maleate by enhanced CT/MRI scan every cycle. Objective Response Rate (ORR) is defined as participants who had complete response (CR) or partial response(PR) divided by the total number of patients.	each 42 days up to intolerance the toxicity or PD (up to 36 months)	No
Secondary	Disease Control Rate (DCR)	To evaluate the effectiveness of Anlotinib Hydrochloric Capsule by enhanced CT/MRI scan every two cycles or Sunitinib maleate by enhanced CT/MRI scan every cycle. Disease Control Rate (DCR) defined as the percentage of participants with Disease Control best overall response (complete response, partial response or stable disease).	each 42 days up to intolerance the toxicity or PD (up to 36 months)	No
Secondary	Overall Survival (OS)	OS was defined as time from date of randomization to date of death due to any cause. For participants still alive at the time of analysis, OS time was censored on last date that participants were known to be alive.	From randomization until death (up to 36 months)	No

External Links

•   Druginfo
•   NLM
•   Rarediseases
•   Sunitinib