Phase II Study of Anlotinib in Patients With Advanced Renal Cell Carcinoma That Have Failed Or Are Intolerant To TKIs Therapy

CTTQ

Status and phase: Unknown; Phase 2

Conditions: Renal Cell Carcinoma

Treatments: Drug: Anlotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02072044

ALTN-06-IIB

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Anlotinib

Experimental group

Description:

Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Treatment:

Drug: Anlotinib