Study of IMC-11F8 in Participants With Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00835185
First received: February 2, 2009
Last updated: December 21, 2015
Last verified: December 2015
Results First Received: December 21, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Metastatic Colorectal Cancer
Interventions: Biological: IMC-11F8 (necitumumab)
Drug: Oxaliplatin
Drug: Folinic acid (FA)
Drug: 5-FU

  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
Participants with known best overall response and off study treatment were considered to be completed.

Reporting Groups
  Description
IMC-11F8 (Necitumumab) + mFOLFOX-6

On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:

  • 800 milligrams (mg) IMC-11F8 intravenous (IV) infusion over 50 minutes
  • 85 milligrams per meter square (mg/m²) oxaliplatin IV infusion over 2 hours
  • 400 mg/m² folinic acid
  • 400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
  • A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent or until other criteria for treatment discontinuation were met.

Participant Flow:   Overall Study
    IMC-11F8 (Necitumumab) + mFOLFOX-6  
STARTED     44  
Received at Least 1 Dose of Study Drug     44  
COMPLETED     44  
NOT COMPLETED     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.
All enrolled participants who received any quantity of study drug.

Reporting Groups
  Description
IMC-11F8 (Necitumumab) + mFOLFOX-6

On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:

  • 800 mg IMC-11F8 IV infusion over 50 minutes
  • 85 mg/m² oxaliplatin IV infusion over 2 hours
  • 400 mg/m² folinic acid
  • 400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
  • A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met.

Baseline Measures
    IMC-11F8 (Necitumumab) + mFOLFOX-6  
Number of Participants  
[units: participants]
  44  
Age  
[units: years]
Mean (Standard Deviation)
  63.3  (11.75)  
Gender  
[units: participants]
 
Female     19  
Male     25  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     31  
Not Hispanic or Latino     13  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     2  
White     42  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
Belgium     13  
Spain     31  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response )   [ Time Frame: Up to 30 Months ]

2.  Secondary:   Overall Survival (OS)   [ Time Frame: First dose to date of death from any cause up to 30 months ]

3.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: First dose to measured PD or death up to 30 months ]

4.  Secondary:   Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) or Death   [ Time Frame: First dose to end of treatment and 30-day post treatment follow-up up to 31 months ]

5.  Secondary:   Duration of Response   [ Time Frame: Time of response to time of measured PD or death up to 30 months ]

6.  Secondary:   Serum Anti-IMC-11F8 Antibody Assessment (Immunogenicity)   [ Time Frame: Baseline up to last day of treatment plus 45 days after last treatment (127 weeks) ]

7.  Secondary:   Maximum Concentration (Cmax) of IMC-11F8 at Study Day 1 of Cycle 1   [ Time Frame: Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose ]

8.  Secondary:   Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0-∞)] of IMC-11F8 at Study Day 1 of Cycle 1   [ Time Frame: Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose ]

9.  Secondary:   Half-Life (t1/2) of IMC-11F8 at Study Day 1 of Cycle 1   [ Time Frame: Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose ]

10.  Secondary:   Clearance (CL) of IMC-11F8 at Study Day 1 of Cycle 1   [ Time Frame: Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose ]

11.  Secondary:   Volume of Distribution (Vss) of IMC-11F8 at Study Day 1 of Cycle 1   [ Time Frame: Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose ]

12.  Secondary:   Cmax at Study Day 1 of Cycles 2 Through 6   [ Time Frame: Day 1 Cycles 2 through 6 predose and 1 hour postdose ]

13.  Secondary:   Area Under the Curve (AUC) at Study Day 1 of Cycles 2 Through 6   [ Time Frame: Day 1 Cycles 2 through 6 predose and 1 hour postdose ]

14.  Secondary:   t1/2 at Study Day 1 of Cycles 2 Through 6   [ Time Frame: Day 1 Cycles 2 through 6 predose and 1 hour post dose ]

15.  Secondary:   CL at Study Day 1 of Cycles 2 Through 6   [ Time Frame: Day 1 Cycles 2 through 6 predose and 1 hour postdose ]

16.  Secondary:   Vss at Study Day 1 of Cycles 2 Through 6   [ Time Frame: Day 1 Cycles 2 through 6 predose and 1 hour postdose ]

17.  Secondary:   Change From Baseline in Tumor Size   [ Time Frame: Baseline, 29 Months ]

18.  Secondary:   Kirsten Rat Sarcoma (KRAS) Mutation Status   [ Time Frame: Baseline ]


  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: NCT00835185     History of Changes
Other Study ID Numbers: 13926
2006-003147-23 ( EudraCT Number )
CP11-0602 ( Other Identifier: ImClone Systems )
I4X-IE-JFCD ( Other Identifier: Eli Lilly and Company )
Study First Received: February 2, 2009
Results First Received: December 21, 2015
Last Updated: December 21, 2015
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Spain: Agencia Española de Medicamentos y Productos Sanitarios