This trial is active, not recruiting.

Condition renal cell carcinoma(rcc)
Treatment anlotinib
Phase phase 2
Target VEGF
Sponsor Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
Start date December 2013
End date December 2016
Trial size 60 participants
Trial identifier NCT02072044, ALTN-06-IIB


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Anlotinib p.o. qd

Primary Outcomes

Progress Free Survival (PFS)
time frame: each 42 days up to PD or death (up to 36 months)

Secondary Outcomes

Objective Response Rate
time frame: each 42 days up to intolerance the toxicity or PD (up to 36 months)
Disease Control Rate (DCR)
time frame: each 42 days up to intolerance the toxicity or PD (up to 36 months)
Overall Survival (OS)
time frame: From randomization until death (up to 36 months)

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd.