Overview

This trial is active, not recruiting.

Conditions anlotinib, rcc
Treatments anlotinib, sunitinib maleate
Phase phase 2
Targets FLT-3, KIT, PDGF, VEGF
Sponsor Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
Start date December 2013
End date December 2016
Trial size 133 participants
Trial identifier NCT02072031, ALTN-06-IIA

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
anlotinib
Anlotinib p.o. qd
(Active Comparator)
Sunitinib 50 mg qd p.o., 4 weeks out of 6.The treatment continued until disease progression or intolerable toxicity happened or patients withdrawal of consent.
sunitinib maleate
Sunitinib 50 mg p.o. qd

Primary Outcomes

Measure
Progress free survival (PFS)
time frame: each 42 days up to PD or death(up to 36 months)

Secondary Outcomes

Measure
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.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

Additional Information

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