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

NCT02072031 | Unknown Phase 2

• 1 other identifier: ALTN-06-IIA
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 15

Brief 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).

Conditions

Anlotinib; RCC

Keywords

Anlotinib; Sunitinib; Renal Cell Carcinoma（RCC）

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (3)

• Objective Response Rate

  each 42 days up to intolerance the toxicity or PD (up to 36 months)

• Disease Control Rate (DCR)

  each 42 days up to intolerance the toxicity or PD (up to 36 months)

• Overall Survival (OS)

  From randomization until death (up to 36 months)

Study Arms (2)

Anlotinib

EXPERIMENTAL

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

Drug: Anlotinib

Sunitinib maleate

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.

Drug: Sunitinib maleate

Interventions

Anlotinib DRUG

Anlotinib p.o. qd

Anlotinib

Sunitinib maleate DRUG

Sunitinib 50 mg p.o. qd

Sunitinib maleate

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically confirmed advanced renal cell carcinoma including clear cell component and not available for surgery
• Without drug treatment for RCC or chemotherapy/cytokine therapy failure or resistant patients)
• With measurable disease (using RECIST1.1)
• years,ECOG PS:0-1,Life expectancy of more than 3 months
• Other cytotoxic drugs,radiation therapy,or surgery≥4 weeks
• main organs function is normal
• Signed and dated informed consent

You may not qualify if:

• Previously received targeted therapy of the metastatic renal cell carcinoma (such as sunitinib, Sorafenib)
• patients has many influence factors toward oral medications
• Known brain metastases
• 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.
• patients failed to heal wounds or fractures for Long-term
• patients occurred venous thromboembolic events within 6 months
• patients has HIV-positive or organ transplantation

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (15)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100005, China

Location

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, 404100, China

Location

Gansu Province Tumor Hospital

Lanzhou, Gansu, 730050, China

Location

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510000, China

Location

Guangxi medical university affiliated tumor hospital

Nanning, Guangxi, 530021, China

Location

Harbin medical university affiliated tumor hospital

Haerbin, Heilongjiang, 150000, China

Location

The 81st Hospital of Chinese PLA

Nanjing, Jiangsu, 210000, China

Location

Jilin Cancer Hospital

Changchun, Jilin, 132000, China

Location

China General Hospital of Shenyang Military Region

Shenyang, Liaoning, 110000, China

Location

Liaoning Province Tumor Hospital

Shenyang, Liaoning, 110042, China

Location

Qilu Hospital，Shandong University

Jinan, Shandong, 250012, China

Location

Cancer Hospital of Fudan University

Shanghai, Shanghai Municipality, 200000, China

Location

West China Hospital，Sichuan University

Chengdu, Sichuan, 610041, China

Location

Tianjin Medical University Cancer Hospital

Tianjin, Tianjin Municipality, 300000, China

Location

Related Publications (1)

• Lin J, Fang Q, Zheng X. Cost-effectiveness analysis of anlotinib versus sunitinib as first-line treatment for metastatic renal cell carcinoma in China. PLoS One. 2023 Feb 7;18(2):e0281402. doi: 10.1371/journal.pone.0281402. eCollection 2023.

  PMID: 36749752 DERIVED

Related Links

• NLM
• Druginfo
• Sunitinib

MeSH Terms

Interventions

anlotinib; Sunitinib

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2014
• First Posted: February 26, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 26, 2016

Record last verified: 2016-04

Locations

CN (15)