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A Study of IMC-A12 or Ramucirumab Plus Mitoxantrone and Prednisone in Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00683475
First received: May 19, 2008
Last updated: October 7, 2014
Last verified: October 2014
Results First Received: May 16, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Biological: IMC-A12
Drug: Mitoxantrone
Drug: Prednisone
Biological: IMC-1121B (ramucirumab)

  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
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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
IMC-A12 + Mitoxantrone + Prednisone IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.

Participant Flow:   Overall Study
    IMC-A12 + Mitoxantrone + Prednisone   IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone
STARTED   69   69 
Received Any Quantity of Study Drug   66   66 
COMPLETED   65   66 
NOT COMPLETED   4   3 
Withdrawal by Subject                1                0 
Never Treated: Adverse Event                2                3 
Never Treated: Progressive Disease                1                0 



  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.
Modified intent to treat population (mITT): All participants who received any quantity of study drug.

Reporting Groups
  Description
IMC-A12 + Mitoxantrone + Prednisone IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
Total Total of all reporting groups

Baseline Measures
   IMC-A12 + Mitoxantrone + Prednisone   IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone   Total 
Overall Participants Analyzed 
[Units: Participants]
 66   66   132 
Age 
[Units: Years]
     
<=18 years   0   0   0 
Between 18 and 65 years   30   21   51 
>=65 years   36   45   81 
Gender 
[Units: Participants]
     
Female   0   0   0 
Male   66   66   132 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   1   3   4 
Not Hispanic or Latino   65   63   128 
Unknown or Not Reported   0   0   0 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   61   58   119 
Black Or African American   4   6   10 
Other   1   2   3 
Region of Enrollment 
[Units: Participants]
     
United States   66   66   132 


  Outcome Measures
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1.  Primary:   Composite Progression-free Survival (cPFS)   [ Time Frame: Randomization to composite progressive disease, up to 23.4 months ]

2.  Secondary:   Summary Listing of Participants Reporting Treatment-Emergent Adverse Events   [ Time Frame: Randomization to 36.3 months ]

3.  Secondary:   Time to Radiographic Evidence of Disease Progression   [ Time Frame: Randomization to date of radiographic progression, up to 36.3 months ]

4.  Secondary:   Prostate Specific Antigen (PSA) Response Rate   [ Time Frame: Baseline up to data cut-off date (up to 36.3 months) ]

5.  Secondary:   Composite Progression-free Survival (cPFS) at 6-months   [ Time Frame: 6 months ]

6.  Secondary:   Composite Progression-free Survival (cPFS) at 9-months   [ Time Frame: 9 months ]

7.  Secondary:   Composite Progression-free Survival (cPFS) at 12-months   [ Time Frame: 12 months ]

8.  Secondary:   Overall Survival (OS)   [ Time Frame: First dose to death due to any cause up to 36.3 months ]

9.  Secondary:   Objective Response Rate (ORR)   [ Time Frame: Baseline to date of progressive disease or death up to 36.3 months ]

10.  Secondary:   Maximum Concentration (Cmax) at Study Day 1   [ Time Frame: Day 1 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

11.  Secondary:   Maximum Concentration (Cmax) at Study Day 15   [ Time Frame: Day 15 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

12.  Secondary:   Maximum Concentration (Cmax) at Study Day 16   [ Time Frame: Day 16 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

13.  Secondary:   Maximum Concentration (Cmax) at Study Day 30   [ Time Frame: Day 30 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

14.  Secondary:   Minimum Concentration (Cmin) at Study Day 1   [ Time Frame: Day 1 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

15.  Secondary:   Minimum Concentration (Cmin) at Study Day 15   [ Time Frame: Day 15 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

16.  Secondary:   Minimum Concentration (Cmin) at Study Day 16   [ Time Frame: Day 16 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

17.  Secondary:   Minimum Concentration (Cmin) at Study Day 30   [ Time Frame: Day 30 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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


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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00683475     History of Changes
Other Study ID Numbers: 13924
CP18-0601 ( Other Identifier: ImClone Systems )
I4T-IE-JVBS ( Other Identifier: Eli Lilly and Company )
Study First Received: May 19, 2008
Results First Received: May 16, 2014
Last Updated: October 7, 2014
Health Authority: United States: Food and Drug Administration