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A Study of Ramucirumab in Participants With Gastric, Esophageal, and Gastroesophageal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01246960
First received: November 8, 2010
Last updated: October 3, 2014
Last verified: October 2014
Results First Received: October 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Stomach Cancer
Esophageal Cancer
Interventions: Biological: Ramucirumab
Drug: Placebo
Drug: Oxaliplatin
Drug: Leucovorin
Drug: 5-Fluorouracil

  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
No text entered.

Reporting Groups
  Description
Ramucirumab and mFOLFOX6

Ramucirumab: 8 milligrams per kilogram (mg/kg) intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering modified FOLFOX6 (mFOLFOX6).

mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).

  • Oxaliplatin 85 milligrams per square meter (mg/m^2)
  • Leucovorin 400 mg/m^2
  • 5-Fluorouracil (5-FU) 400 mg/m^2 bolus
  • 5-FU 2400 mg/m^2 continuous given over 46-48 hours

Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met.

Placebo and mFOLFOX6

Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.

mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).

  • Oxaliplatin 85 mg/m^2
  • Leucovorin 400 mg/m^2
  • 5-FU 400 mg/m^2 bolus
  • 5-FU 2400 mg/m^2 continuous given over 46-48 hours

Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met.


Participant Flow:   Overall Study
    Ramucirumab and mFOLFOX6     Placebo and mFOLFOX6  
STARTED     84     84  
Received Any Quantity of Study Drug     82     80  
COMPLETED     78     80  
NOT COMPLETED     6     4  
Lost to Follow-up                 3                 1  
Withdrawal (by participant or physician)                 3                 3  



  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: all randomized participants.

Reporting Groups
  Description
Ramucirumab and mFOLFOX6

Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.

mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).

  • Oxaliplatin: 85 mg/m^2
  • Leucovorin: 400 mg/m^2
  • 5-FU: 400 mg/m^2 bolus
  • 5-FU: 2400 mg/m^2 continuous given over 46-48 hours

Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met.

Placebo and mFOLFOX6

Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.

mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).

  • Oxaliplatin: 85 mg/m^2
  • Leucovorin: 400 mg/m^2
  • 5-FU: 400 mg/m^2 bolus
  • 5-FU: 2400 mg/m^2 continuous given over 46-48 hours

Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met.

Total Total of all reporting groups

Baseline Measures
    Ramucirumab and mFOLFOX6     Placebo and mFOLFOX6     Total  
Number of Participants  
[units: participants]
  84     84     168  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     42     56     98  
>=65 years     42     28     70  
Gender  
[units: participants]
     
Female     21     23     44  
Male     63     61     124  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     4     9     13  
Not Hispanic or Latino     80     75     155  
Unknown or Not Reported     0     0     0  
Race/Ethnicity, Customized  
[units: participants]
     
Asian     2     4     6  
Native Hawaiian or Other Pacific Islander     2     1     3  
Black or African American     3     3     6  
White     77     76     153  
Region of Enrollment  
[units: participants]
     
United States     84     84     168  



  Outcome Measures
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1.  Primary:   Progression-Free Survival (PFS)   [ Time Frame: Randomization to measured PD or date of death from any cause (up to Month 25.0) ]

2.  Secondary:   Overall Survival (OS)   [ Time Frame: Randomization to date of death from any cause (up to Month 28.3) ]

3.  Secondary:   Percentage of Participants Achieving an Objective Response (Objective Response Rate)   [ Time Frame: Randomization to measured PD (up to Month 23.0) ]

4.  Secondary:   Duration of Response   [ Time Frame: Time of first response to measured PD (up to Month 23.0) ]

5.  Secondary:   Time to Disease Progression (TTP)   [ Time Frame: Randomization to measured PD (up to Month 25.0) ]

6.  Secondary:   Number of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies   [ Time Frame: Months 1, 2, 4, 6, and 8 ]

7.  Other Pre-specified:   Number of Participants With Adverse Events (AEs)   [ Time Frame: Baseline through study completion (up to Month 28.3) ]


  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


Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01246960     History of Changes
Other Study ID Numbers: 14057, I4T-MC-JVBT
Study First Received: November 8, 2010
Results First Received: October 3, 2014
Last Updated: October 3, 2014
Health Authority: United States: Food and Drug Administration