Study of IMC-1121B (Ramucirumab) in Participants With Liver Cancer Who Have Not Previously Been Treated With Chemotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00627042
First received: February 18, 2008
Last updated: September 29, 2014
Last verified: September 2014
Results First Received: May 16, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hepatocellular Carcinoma
Intervention: Biological: Ramucirumab (IMC-1121B)

  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 (IMC-1121B) Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.

Participant Flow:   Overall Study
    Ramucirumab (IMC-1121B)  
STARTED     42  
Received at Least 1 Dose of Study Drug     42  
COMPLETED     40  
NOT COMPLETED     2  
Withdrawal by Subject                 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.
Participants who received at least 1 dose of ramucirumab.

Reporting Groups
  Description
Ramucirumab (IMC-1121B) Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.

Baseline Measures
    Ramucirumab (IMC-1121B)  
Number of Participants  
[units: participants]
  42  
Age, Customized  
[units: participants]
 
Between 18 and 65 years     27  
>=65 years     15  
Gender  
[units: participants]
 
Female     8  
Male     34  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     3  
Not Hispanic or Latino     39  
Unknown or Not Reported     0  
Race/Ethnicity, Customized  
[units: participants]
 
American Indian or Alaska Native     1  
Asian     4  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     2  
White     32  
Race Other: Hispanic     1  
Race Other: Black and Asian     1  
Race Other: Greek     1  
Region of Enrollment  
[units: participants]
 
United States     42  
Study-Specific Measure [1]
[units: participants]
 
A     31  
B     11  
Study-Specific Measure [2]
[units: participants]
 
A     2  
B     4  
C     36  
Study-Specific Measure [3]
[units: participants]
 
Present     7  
Absent     32  
Not Available     2  
Missing     1  
Study-Specific Measure [4]
[units: participants]
 
Present     32  
Absent     10  
Study-Specific Measure [5]
[units: participants]
 
Hepatitis B Positive     3  
Hepatitis C Positive     19  
Hepatitis B and C Positive     2  
Hepatitis B and C Negative     15  
[1] The Child-Pugh classification was used to assess the prognosis of chronic liver disease. The score employed 5 clinical measures of liver disease: encephalopathy, ascites, albumin, prothrombin time, and bilirubin. Each measure was scored from 1 (normal) and 3 (most severe derangement). The total score for the Child-Pugh assessment was calculated as the sum of the 5 contributing scores with a total possible score of 15. Chronic liver disease was classified into Child-Pugh classes A to C, employing the total score from above: 5-6=Class A; 7-9=Class B; 10-15=Class C.
[2] Barcelona Clinic Liver Cancer stage A, B, C [Franca AV et al., Braz J Med Biol Res. 2004;37(11):1689-1705]. Based on tumor burden (TB, amount of cancer in body), Child-Pugh (CP) class, Eastern Cooperative Oncology Group performance status test (PST) functional impairment [0 (Fully Active) to 5 (Death)]. Stage A [TB=single nodule or 3 nodules <3 cm, CP=A or B, PST=0 (fully active)]. Stage B (TB=single nodule >5 cm or multinodular, CP=A or B, PST=0). Stage C [TB=vascular invasion and/or metastasis, CP=A or B, PST=1 or 2 (ambulatory, restricted work activity or ambulatory, no work activity)].
[3] The number of participants with macrovascular invasion (gross vascular invasion of major portal or hepatic veins) present, absent, not available, or missing.
[4] The number of participants with extrahepatic metastasis (metastases originating or occurring outside the liver) present or absent.
[5] Number of participants with hepatitis status data (N=39). Participants whose hepatitis status is hepatitis B and C positive are not counted in the hepatitis B positive or hepatitis C positive category.



  Outcome Measures
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1.  Primary:   Progression Free Survival (PFS) in Participants With Unresectable Hepatocellular Cancer Treated With the Monoclonal Antibody Ramucirumab   [ Time Frame: First dose to date of progressive disease or death due to any cause [every 3 cycles up to 18 months (1 cycle=2 weeks)] ]

2.  Secondary:   Time to Progression   [ Time Frame: First dose to date of PD [every 3 cycles up to 18 months (1 cycle=2 weeks)] ]

3.  Secondary:   Overall Survival   [ Time Frame: First dose to death due to any cause up to 37.5 months ]

4.  Secondary:   Percentage of Participants With Complete Response or Partial Response (Objective Response Rate)   [ Time Frame: First dose to date of objective progressive disease (PD) or death up to 18 months ]

5.  Secondary:   Duration of Response   [ Time Frame: Time of first response (CR or PR) to disease progression, or death due to any cause [every 3 cycles up to 18 months (1 cycle=2 weeks)] ]

6.  Secondary:   Number of Participants With Serum Anti-Ramucirumab Antibodies   [ Time Frame: Prior to dosing at baseline, Cycles 4 and 7, and 30 days after end of therapy (1 cycle=2 weeks) ]

7.  Secondary:   Number of Participants With Drug-Related Treatment-Emergent Adverse Events   [ Time Frame: First dose to 37.5 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
The duration of response results should be interpreted with caution since the sample size for this analysis was very small (2 participants).


  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: NCT00627042     History of Changes
Other Study ID Numbers: 13922, CP12-0710, I4T-IE-JVBQ
Study First Received: February 18, 2008
Results First Received: May 16, 2014
Last Updated: September 29, 2014
Health Authority: United States: Food and Drug Administration