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Study of IMC-1121B (Ramucirumab) With Best Supportive Care in Participants With Gastric Cancer and Adenocarcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00917384
First received: June 8, 2009
Last updated: December 8, 2016
Last verified: December 2016
Results First Received: May 21, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Gastric Cancer
Adenocarcinoma
Interventions: Biological: ramucirumab
Drug: Placebo
Other: Best Supportive Care (BSC)

  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
In the Participant Flow participants who completed were those who died due to any cause or were alive and on study at conclusion but off treatment.

Reporting Groups
  Description
IMC-1121B (Ramucirumab ) Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined appropriate by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
Placebo Participants received placebo by intravenous infusion every 2 weeks plus BSC as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.

Participant Flow:   Overall Study
    IMC-1121B (Ramucirumab )   Placebo
STARTED   238   117 
Received at Least 1 Dose of Study Drug   236   115 
COMPLETED   224   113 
NOT COMPLETED   14   4 
Lost to Follow-up                4                2 
Withdrawal by Subject                10                2 



  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.
All randomized participants.

Reporting Groups
  Description
IMC-1121B (Ramucirumab) Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
Placebo Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
Total Total of all reporting groups

Baseline Measures
   IMC-1121B (Ramucirumab)   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 238   117   355 
Age 
[Units: Years]
Median (Full Range)
 60.0 
 (30 to 86) 
 60.0 
 (24 to 87) 
 60.0 
 (24 to 87) 
Gender 
[Units: Participants]
Count of Participants
     
Female      69  29.0%      38  32.5%      107  30.1% 
Male      169  71.0%      79  67.5%      248  69.9% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      41  17.2%      19  16.2%      60  16.9% 
Not Hispanic or Latino      197  82.8%      98  83.8%      295  83.1% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
Argentina   4   2   6 
Australia   8   4   12 
Bosnia and Herzegovina   1   3   4 
Brazil   24   14   38 
Canada   8   2   10 
Chile   1   1   2 
Colombia   2   1   3 
Czech Republic   24   13   37 
Egypt   1   0   1 
Spain   12   4   16 
United Kingdom   13   4   17 
Guatemala   6   2   8 
Croatia   7   0   7 
Indonesia   2   1   3 
India   16   8   24 
Italy   23   11   34 
Korea, Republic of   11   6   17 
Lebanon   1   0   1 
Malta   2   3   5 
New Zealand   1   1   2 
Philippines   1   1   2 
Poland   9   4   13 
Romania   13   4   17 
Russian Federation   14   8   22 
Thailand   1   0   1 
Turkey   5   1   6 
Taiwan   3   0   3 
United States   25   18   43 
South Africa   0   1   1 
Race 
[Units: Participants]
     
White   181   91   272 
Asian   39   17   56 
Black   4   2   6 
Other   14   7   21 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival (OS)   [ Time Frame: Randomization up to 28 months post-randomization ]

2.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: Randomization up to 17 months ]

3.  Secondary:   Percentage of Participants Who Are Progression-Free at Week 12 (PFS Rate)   [ Time Frame: Week 12 post-randomization ]

4.  Secondary:   Percentage of Participants With Objective Response (Objective Response Rate [ORR])   [ Time Frame: Randomization up to 17 months post-randomization ]

5.  Secondary:   Duration of Response (DOR)   [ Time Frame: Randomization up to 17 months post-randomization ]

6.  Secondary:   Change From Baseline in Quality of Life (QoL) as Measured by the European Organisation for Research and Treatment of Cancer Questionnaire (EORTC-QLQ-C30)   [ Time Frame: Baseline up to Cycle 10 (18 weeks [1 cycle=2 weeks]) ]

7.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: Randomization up to 18 months ]

8.  Secondary:   Maximum Concentration (Cmax) of IMC-1121B   [ Time Frame: 6 weeks post-randomization ]

9.  Secondary:   Number of Participants Who Developed Antibodies Against IMC-1121B   [ Time Frame: Baseline, 12 Weeks ]


  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
No text entered.


  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: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00917384     History of Changes
Other Study ID Numbers: 13893
2008-005964-15 ( Registry Identifier: MHRA )
CP12-0715 ( Other Identifier: ImClone Systems )
I4T-IE-JVBD ( Other Identifier: Eli Lilly and Company )
Study First Received: June 8, 2009
Results First Received: May 21, 2014
Last Updated: December 8, 2016