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Phase III Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric Cancer

This study has been completed.
Sponsor:
Collaborators:
Fudan University
The 81 Hospital of PLA
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01512745
First received: January 13, 2012
Last updated: August 30, 2016
Last verified: April 2015
Results First Received: August 6, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Advanced or Metastatic Gastric Cancer
Interventions: Drug: apatinib
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Apatinib apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
Placebo placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent

Participant Flow:   Overall Study
    Apatinib   Placebo
STARTED   176   91 
COMPLETED   136   71 
NOT COMPLETED   40   20 
Adverse Event                22                3 
Death                9                13 
Withdrawal by Subject                2                2 
Lost to Follow-up                4                0 
Lack of Efficacy                2                2 
Protocol Violation                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
5 participants in the apatinib group and 1 in the placebo group withdrew from the study before receiving the assigned treatments.As a result,267 randomly assigned participants were included in Full Analysis Set (FAS),with 176 assigned to the apatinib group and 91 assigned to the placeo group.

Reporting Groups
  Description
Apatinib apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
Placebo placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
Total Total of all reporting groups

Baseline Measures
   Apatinib   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 176   91   267 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.01  (9.92)   56.08  (9.74)   55.37  (9.81) 
Gender 
[Units: Participants]
     
Female   44   22   66 
Male   132   69   201 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression Free Survival(PFS)   [ Time Frame: 30 months ]

2.  Primary:   Overall Survival(OS)   [ Time Frame: 30 months ]

3.  Secondary:   Disease Control Rate(DCR)   [ Time Frame: 30 months ]

4.  Secondary:   Objective Response Rate(ORR)   [ Time Frame: 30 months ]

5.  Secondary:   Percentage of Participants With Adverse Events   [ Time Frame: 30 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Co-Director of Clinical Trials
Organization: Fudan University Shanghai Cancer Center, Shanghai; PLA Cancer Centre, The 81 Hospital of PLA, Nangjing
phone: 021-64433755
e-mail: fudanlijin@163.com,qinsk@csco.org.cn



Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT01512745     History of Changes
Other Study ID Numbers: HENGRUI 20101208
Study First Received: January 13, 2012
Results First Received: August 6, 2015
Last Updated: August 30, 2016
Health Authority: China: Food and Drug Administration