A Study of Herceptin (Trastuzumab) in Combination With Standard Chemotherapy in Patients With HER Positive Metastatic Gastric Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01260194
First received: December 13, 2010
Last updated: February 15, 2016
Last verified: February 2016
Results First Received: February 15, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Gastric Cancer
Intervention: Drug: trastuzumab [Herceptin]

  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
No text entered.

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
Trastuzumab Trastuzumab was administered at a loading dose of 8 milligram per kilogram (mg/kg) body weight on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.

Participant Flow:   Overall Study
    Trastuzumab  
STARTED     4  
COMPLETED     3  
NOT COMPLETED     1  
Withdrawal of Consent                 1  



  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.
Intent-to-treat (ITT) population included all participants who received at least 1 dose of study drug and did not report any major protocol violation.

Reporting Groups
  Description
Trastuzumab Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.

Baseline Measures
    Trastuzumab  
Number of Participants  
[units: participants]
  4  
Age  
[units: years]
Mean (Standard Deviation)
  64.8  (7.27)  
Gender  
[units: participants]
 
Female     1  
Male     3  



  Outcome Measures
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1.  Primary:   Median Progression Free Survival (PFS)   [ Time Frame: Baseline up to PD or death (maximum up to 22 months) ]

2.  Secondary:   Overall Survival (OS)   [ Time Frame: Baseline up to death (maximum up to 22 months) ]

3.  Secondary:   Percentage of Participants With Overall Tumor Response   [ Time Frame: Baseline up to PD or death (maximum up to 22 months) ]

4.  Secondary:   Percentage of Participants With Clinical Benefit Response (CBR)   [ Time Frame: Baseline up to PD or death (maximum up to 22 months) ]

5.  Secondary:   Duration of Response (DR)   [ Time Frame: Baseline up to PD or death (maximum up to 22 months) ]

6.  Secondary:   Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)   [ Time Frame: Baseline up to 6 month after last dose of study drug (maximum up to 22 months) ]

7.  Secondary:   Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters   [ Time Frame: Baseline up to 6 month after last dose of study drug (maximum up to 22 months) ]

8.  Secondary:   Number of Participants With Clinically Significant Change From Baseline in Left Ventricular Ejection Fraction (LVEF)   [ Time Frame: Baseline, thereafter every 12 weeks (maximum up to 22 months) ]

9.  Secondary:   Number of Participants With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Gastric Cancer   [ Time Frame: Baseline ]


  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: Medical Communications
Organization: Hoffmann-LaRoche
phone: 800-821-8590
e-mail: genentech@druginfo.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01260194     History of Changes
Other Study ID Numbers: ML25477
Study First Received: December 13, 2010
Results First Received: February 15, 2016
Last Updated: February 15, 2016
Health Authority: India: Drug Controller General