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

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

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).

Study Overview

• Status: Unknown
• Conditions: Anlotinib; RCC
• Intervention / Treatment: Drug: Anlotinib; Drug: Sunitinib maleate

• Study Type: Interventional
• Enrollment (Anticipated): 133
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    • Beijing, Beijing, China, 100005
      • Peking Union Medical College Hospital
  • Chongqing
    • Chongqing, Chongqing, China, 404100
      • Chongqing Cancer Hospital
  • Gansu
    • Lanzhou, Gansu, China, 730050
      • Gansu Province Tumor Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Sun Yat-sen University Cancer Center
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • Guangxi Medical University Affiliated Tumor Hospital
  • Heilongjiang
    • Haerbin, Heilongjiang, China, 150000
      • Harbin medical university affiliated tumor hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • The 81st Hospital of Chinese PLA
  • Jilin
    • Changchun, Jilin, China, 132000
      • Jilin Cancer Hospital
  • Liaoning
    • Shenyang, Liaoning, China, 110000
      • China General Hospital of Shenyang Military Region
    • Shenyang, Liaoning, China, 110042
      • Liaoning Province Tumor Hospital
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital，Shandong University
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Cancer Hospital of Fudan University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital,Sichuan University
  • Tianjin
    • Tianjin, Tianjin, China, 300000
      • Tianjin Medical University Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Anlotinib; Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent	Drug: Anlotinib; Anlotinib p.o. qd
ACTIVE_COMPARATOR: Sunitinib maleate; 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; Sunitinib 50 mg p.o. qd

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate	To evaluate the effectiveness of Anlotinib Hydrochloric Capsule by enhanced CT/MRI scan every two cycles or Sunitinib maleate by enhanced CT/MRI scan every cycle. Objective Response Rate (ORR) is defined as participants who had complete response (CR) or partial response(PR) divided by the total number of patients.	each 42 days up to intolerance the toxicity or PD (up to 36 months)
Disease Control Rate (DCR)	To evaluate the effectiveness of Anlotinib Hydrochloric Capsule by enhanced CT/MRI scan every two cycles or Sunitinib maleate by enhanced CT/MRI scan every cycle. Disease Control Rate (DCR) defined as the percentage of participants with Disease Control best overall response (complete response, partial response or stable disease).	each 42 days up to intolerance the toxicity or PD (up to 36 months)
Overall Survival (OS)	OS was defined as time from date of randomization to date of death due to any cause. For participants still alive at the time of analysis, OS time was censored on last date that participants were known to be alive.	From randomization until death (up to 36 months)

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• NLM
• Druginfo
• Sunitinib

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (ANTICIPATED): December 1, 2016
• Study Completion (ANTICIPATED): December 1, 2016

Study Registration Dates

• First Submitted: January 20, 2014
• First Submitted That Met QC Criteria: February 24, 2014
• First Posted (ESTIMATE): February 26, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): April 26, 2016
• Last Update Submitted That Met QC Criteria: April 25, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Sunitinib; Anlotinib; Renal Cell Carcinoma（RCC）
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Carcinoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Protein Kinase Inhibitors; Sunitinib
• Other Study ID Numbers: ALTN-06-IIA