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Study With IMC-A12 (Cixutumumab) in Patients Who Have Not Previously Been Treated With Chemotherapy With Metastatic Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00520481
Recruitment Status : Completed
First Posted : August 24, 2007
Results First Posted : July 19, 2018
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Adenocarcinoma of the Prostate
Intervention: Drug: IMC-A12 (Cixutumumab)

  Participant Flow

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
Participants who had results for the primary outcome measures were considered to have completed the study. The primary outcome measure is: Composite Time to Disease Progression (cTTP) for Participants Treated With Cixutumumab.

Reporting Groups
  Description
IMC-A12 (Cixutumumab) 10 mg/kg Cixutumumab was administered at 10 milligrams/kilogram (mg/kg) as intravenous (i.v.) infusion over 1 hour every 2 weeks until disease progression or intolerable toxicity.
Cixutumumab 20 mg/kg Cixutumumab was administered at 20 mg/kg as i.v. infusion over 1 hour every 3 weeks until disease progression or intolerable toxicity.

Participant Flow:   Overall Study
    IMC-A12 (Cixutumumab) 10 mg/kg   Cixutumumab 20 mg/kg
STARTED   31   10 
Received at Least 1 Dose of Study Drug   31   10 
COMPLETED   24   9 
NOT COMPLETED   7   1 
Adverse Event                4                1 
Withdrawal by Subject                3                0 



  Baseline Characteristics

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 participants who received at least 1 dose of study drug.

Reporting Groups
  Description
Cixutumumab 10 mg/kg Cixutumumab was administered at 10 mg/kg as i.v. infusion over 1 hour every 2 weeks until disease progression or intolerable toxicity.
Cixutumumab 20 mg /kg Cixutumumab was administered at 20 mg/kg as i.v. infusion over 1 hour every 3 weeks until disease progression or intolerable toxicity.
Total Total of all reporting groups

Baseline Measures
   Cixutumumab 10 mg/kg   Cixutumumab 20 mg /kg   Total 
Overall Participants Analyzed 
[Units: Participants]
 31   10   41 
Age 
[Units: Years]
Mean (Standard Deviation)
 70.0  (9.26)   70.2  (6.78)   70.1  (8.64) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female   0   0   0 
Male   31   10   41 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino   2   0   2 
Not Hispanic or Latino   29   10   39 
Unknown or Not Reported   0   0   0 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
White   30   10   40 
Hispanic   1   0   1 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   31   10   41 


  Outcome Measures

1.  Primary:   Composite Time to Disease Progression (cTTP) for Participants Treated With Cixutumumab   [ Time Frame: From first dose of study drug until progressive disease (Up to 49.2 months) ]

2.  Primary:   Area Under the Curve (AUC) of IMC-A12 Administered at a Dose of 20 mg/kg Every 3 Weeks   [ Time Frame: Up to 42 months (predose, 1, 168, 336 and 504 h postdose for Cycles 1 to 4; additionally 24, 72 or 96 h, 120 and 240 or 246 h postdose for Cycle 4; predose and 1 h post dose for Cycles 5 to 9) ]

3.  Primary:   Maximum Concentration (Cmax) of IMC-A12 Administered at a Dose of 20 mg/kg Every 3 Weeks   [ Time Frame: Up to 42 months (predose, 1, 168, 336 and 504 h postdose for Cycles 1 to 4; additionally 24, 72 or 96 h, 120 and 240 or 246 h post dose for Cycle 4; predose and 1 h postdose for Cycles 5 to 9) ]

4.  Secondary:   Number of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs)   [ Time Frame: From randomization up to 49.2 months (and 30 day follow-up) ]

5.  Secondary:   Time to Radiographically Evident Disease Progression   [ Time Frame: From first dose of study drug until radiographic progression (up to 48.6 months) ]

6.  Secondary:   Number of Participants With Complete Response (CR) or Partial Response (PR) (Tumor Response Rate)   [ Time Frame: From Randomization up to progressive disease (49.2 months) ]

7.  Secondary:   Percentage of Participants With Prostate Specific Antigen (PSA) Response Rate   [ Time Frame: From Randomization up to 6.21 months ]

8.  Secondary:   Progression-Free Survival (PFS) Rate at 6 Months   [ Time Frame: From randomization up to 48.6 months ]

9.  Secondary:   Area Under the Curve (AUC) of IMC-A12 Administered at a Dose of 10 mg/kg Every 2 Weeks   [ Time Frame: Up to 42 months (predose and 1 h postdose for Cycles 1, 5, 9, 13, 17 and 21; additionally immediately following dosing, 168 and 336 h postdose for Cycle 1 only) ]

10.  Secondary:   Maximum Concentration (Cmax) of IMC-A12 Administered at a Dose of 10 mg/kg Every 2 Weeks   [ Time Frame: Up to 42 months (predose and 1 h postdose for Cycles 1, 5, 9, 13, 17 and 21; additionally immediately following dosing, 168 and 336 h postdose for Cycle 1 only) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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



Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00520481     History of Changes
Other Study ID Numbers: 13934
CP13-0603 ( Other Identifier: ImClone Systems )
I5A-IE-JAEJ ( Other Identifier: Eli Lilly and Company )
First Submitted: August 22, 2007
First Posted: August 24, 2007
Results First Submitted: March 17, 2018
Results First Posted: July 19, 2018
Last Update Posted: July 19, 2018