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

Primary Purpose

Anlotinib, RCC

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Anlotinib
Sunitinib maleate
Sponsored by
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anlotinib focused on measuring Anlotinib, Sunitinib, Renal Cell Carcinoma（RCC）

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Peking Union Medical College Hospital
  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • Chongqing Cancer Hospital
  • Gansu Province Tumor Hospital
  • Sun Yat-Sen University Cancer Center
  • Guangxi medical university affiliated tumor hospital
  • Harbin medical university affiliated tumor hospital
  • The 81st Hospital of Chinese PLA
  • Jilin Cancer Hospital
  • China General Hospital of Shenyang Military Region
  • Liaoning Province Tumor Hospital
  • Qilu Hospital，Shandong University
  • Cancer Hospital of Fudan University
  • West China Hospital，Sichuan University
  • Tianjin Medical University Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Anlotinib

Sunitinib maleate

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

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.
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).
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.

Full Information

First Posted
January 20, 2014
Last Updated
April 25, 2016
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02072031
Brief Title
Phase II Study of Anlotinib Versus Sunitinib in Patients With Advanced Renal Cell Carcinoma（RCC）
Official Title
A Randomized, Positive-controlled, Multicenter, Phase II Study of Anlotinib(AL3818) in Patients With Advanced Renal Cell Carcinoma(RCC)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anlotinib, RCC
Keywords
Anlotinib, Sunitinib, Renal Cell Carcinoma（RCC）

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
133 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anlotinib
Arm Type
Experimental
Arm Description
Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Arm Title
Sunitinib maleate
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Anlotinib
Intervention Description
Anlotinib p.o. qd
Intervention Type
Drug
Intervention Name(s)
Sunitinib maleate
Intervention Description
Sunitinib 50 mg p.o. qd
Primary Outcome Measure Information:
Title
Progress free survival (PFS)
Description
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".
Time Frame
each 42 days up to PD or death(up to 36 months)
Secondary Outcome Measure Information:
Title
Objective Response Rate
Description
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.
Time Frame
each 42 days up to intolerance the toxicity or PD (up to 36 months)
Title
Disease Control Rate (DCR)
Description
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).
Time Frame
each 42 days up to intolerance the toxicity or PD (up to 36 months)
Title
Overall Survival (OS)
Description
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.
Time Frame
From randomization until death (up to 36 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100005
Country
China
Facility Name
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Chongqing Cancer Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
404100
Country
China
Facility Name
Gansu Province Tumor Hospital
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730050
Country
China
Facility Name
Sun Yat-Sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
Guangxi medical university affiliated tumor hospital
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Facility Name
Harbin medical university affiliated tumor hospital
City
Haerbin
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China
Facility Name
The 81st Hospital of Chinese PLA
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
132000
Country
China
Facility Name
China General Hospital of Shenyang Military Region
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110000
Country
China
Facility Name
Liaoning Province Tumor Hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Facility Name
Qilu Hospital，Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Facility Name
Cancer Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
West China Hospital，Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Tianjin Medical University Cancer Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300000
Country
China

12. IPD Sharing Statement

Links:
URL
http://www.nlm.nih.gov/medlineplus/
Description
NLM
URL
http://druginfo.nlm.nih.gov/drugportal/drugportal.jsp
Description
Druginfo
URL
http://druginfo.nlm.nih.gov/drugportal/ProxyServlet?mergeData=true&objectHandle=DBMaint&APPLICATION_NAME=drugportal&actionHandle=default&nextPage=jsp/drugportal/ResultScreen.jsp&TXTSUPERLISTID=0341031547&QV1=SUNITINIB+MALATE
Description
Sunitinib

Learn more about this trial

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

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