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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00917384
First received: June 8, 2009
Last updated: October 9, 2014
Last verified: October 2014
Results First Received: May 21, 2014  
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
Conditions: Gastric Cancer
Adenocarcinoma
Interventions: Biological: IMC-1121B (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     215     113  
NOT COMPLETED     23     4  
Lost to Follow-up                 4                 2  
Withdrawal by Subject                 5                 1  
On Study Treatment                 14                 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.
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  
Number of Participants  
[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]
     
Female     69     38     107  
Male     169     79     248  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     41     19     60  
Not Hispanic or Latino     197     98     295  
Unknown or Not Reported     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  
Study-Specific Measure  
[units: participants]
     
White     181     91     272  
Asian     39     17     56  
Black     4     2     6  
Other     14     7     21  



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


No publications provided by Eli Lilly and Company

Publications automatically indexed to this study:

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00917384     History of Changes
Other Study ID Numbers: 13893, 2008-005964-15, CP12-0715, I4T-IE-JVBD
Study First Received: June 8, 2009
Results First Received: May 21, 2014
Last Updated: October 9, 2014
Health Authority: Argentina: Ministry of Health
Australia: Human Research Ethics Committee
Brazil: National Health Surveillance Agency
Bosnia: Federal Ministry of Health
Canada: Ethics Review Committee
Chile: Instituto de Salud Pública de Chile
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Croatia: Ethics Committee
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Egypt: Ministry of Health and Population
Guatemala: Ministry of Public Health and Social Assistance
India: Drugs Controller General of India
Indonesia: National Agency of Drug and Food Control
Italy: Ethics Committee
Italy: Ministry of Health
Korea: Food and Drug Administration
Lebanon: Institutional Review Board
Malaysia: Ministry of Health
Malta: Medicines Authority
Mexico: Ethics Committee
Mexico: Federal Commission for Protection Against Health Risks
Mexico: Federal Commission for Sanitary Risks Protection
New Zealand: Ministry of Health
Philippines: Bureau of Food and Drugs
Poland: Ministry of Health
Romania: Ministry of Public Health
Russia: Ministry of Health of the Russian Federation
South Africa: Medicines Control Council
Spain: Comité Ético de Investigación Clínica
Spain: Ethics Committee
Spain: Ministry of Health
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Taiwan: Department of Health
Thailand: Food and Drug Administration
Turkey: Ministry of Health
United Kingdom: Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration