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

CTTQ

Status and phase: Unknown; Phase 2

Conditions: Anlotinib; RCC

Treatments: Drug: Anlotinib; Drug: Sunitinib maleate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02072031

ALTN-06-IIA

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

Enrollment: 133 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.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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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133 participants in 2 patient groups

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

Sunitinib maleate

Active Comparator group

Description:

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.

Treatment:

Drug: Sunitinib maleate