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: May 16, 2014
Last verified: May 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  
Number of Participants  
[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 ]

11.  Secondary:   Maximum Concentration (Cmax) at Study Day 15   [ Time Frame: Day 15 ]

12.  Secondary:   Maximum Concentration (Cmax) at Study Day 16   [ Time Frame: Day 16 ]

13.  Secondary:   Maximum Concentration (Cmax) at Study Day 30   [ Time Frame: Day 30 ]

14.  Secondary:   Minimum Concentration (Cmin) at Study Day 1   [ Time Frame: Day 1 ]

15.  Secondary:   Minimum Concentration (Cmin) at Study Day 15   [ Time Frame: Day 15 ]

16.  Secondary:   Minimum Concentration (Cmin) at Study Day 16   [ Time Frame: Day 16 ]

17.  Secondary:   Minimum Concentration (Cmin) at Study Day 30   [ Time Frame: Day 30 ]


  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: NCT00683475     History of Changes
Other Study ID Numbers: 13924, CP18-0601, I4T-IE-JVBS
Study First Received: May 19, 2008
Results First Received: May 16, 2014
Last Updated: May 16, 2014
Health Authority: United States: Food and Drug Administration