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Study of IMC-11F8 in Participants With Advanced Solid Tumors

This study has been completed.
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01088464
First received: March 16, 2010
Last updated: December 9, 2016
Last verified: December 2016
Results First Received: December 21, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Neoplasms
Intervention: Biological: IMC-11F8

  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
The study had 3 cohorts and dose escalation in successive cohorts was to occur once all the participants completed 1 cycle of therapy. A completed participant was either a participant who completed the initial 6-week treatment period (Cycle 1) or a participant who discontinued therapy for an IMC-11F8 (Necitumumab) related toxicity during Cycle 1.

Reporting Groups
  Description
Cohort 1: Necitumumab Necitumumab 600 milligrams (mg) administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
Cohort 2: Necitumumab Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
Cohort 3: Necitumumab Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.

Participant Flow:   Overall Study
    Cohort 1: Necitumumab   Cohort 2: Necitumumab   Cohort 3: Necitumumab
STARTED   3   6   6 
Received Any Quantity of Study Drug   3   6   6 
COMPLETED   3   6   6 
NOT COMPLETED   0   0   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
Cohort 1: Necitumumab Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
Cohort 2: Necitumumab Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
Cohort 3: Necitumumab Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
Total Total of all reporting groups

Baseline Measures
   Cohort 1: Necitumumab   Cohort 2: Necitumumab   Cohort 3: Necitumumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 3   6   6   15 
Age 
[Units: Years]
Median (Full Range)
 57.2 
 (30.5 to 69.6) 
 64.5 
 (56.2 to 68.9) 
 56.7 
 (51.3 to 75.6) 
 61.2 
 (30.5 to 75.6) 
Gender 
[Units: Participants]
Count of Participants
       
Female      1  33.3%      3  50.0%      4  66.7%      8  53.3% 
Male      2  66.7%      3  50.0%      2  33.3%      7  46.7% 
Race/Ethnicity, Customized 
[Units: Participants]
       
Japanese   3   6   6   15 
Region of Enrollment 
[Units: Participants]
       
Japan   3   6   6   15 
Eastern Cooperative Oncology Group performance status (ECOG PS) [1] 
[Units: Participants]
       
0 = Fully Active   1   1   4   6 
1 = Ambulatory, Restricted Work Activity   2   5   2   9 
[1] ECOG PS was used to classify participants according to their functional impairment. Score 0 = Fully active, able to carry on all pre-disease performance without restriction. Score 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, for example, light house work, office work.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With 1 or More Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)   [ Time Frame: Baseline up to 24 weeks plus 30 days post last dose of study drug ]

2.  Primary:   Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Necitumumab After a Single Dose   [ Time Frame: Cycle 1, Day 1; Cohorts 1 and 3: predose, immediately after end of infusion, 0.5, 1, 2, 6, 24, 96 and 168 hours (h) after end of infusion. Cohort 2: predose, immediately after infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion ]

3.  Primary:   PK: Cmax of Necitumumab After Multiple Doses   [ Time Frame: Cycle 1, Day 29; For Cohorts 1, 2 and 3: predose (prior to fourth infusion for Cohorts 1 and 3; prior to third infusion for Cohort 2), immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion ]

4.  Primary:   PK: Minimum Concentration (Cmin) of Necitumumab After a Single Dose   [ Time Frame: Cycle 1; Cohorts 1, 2 and 3: prior to second infusion ]

5.  Primary:   PK: Cmin of Necitumumab After Multiple Doses   [ Time Frame: Cycle 1; Cohorts 1and 3: prior to fourth infusion. Cohort 2: prior to third infusion ]

6.  Primary:   PK: Area Under the Concentration-Time Curve From Time 0 to Last Time Point [AUC (0-tlast)] of Necitumumab After a Single Dose   [ Time Frame: Cycle 1, Day 1; Cohorts 1 and 3: predose, immediately after end of infusion, 0.5, 1, 2, 6, 24, 96 and 168 h after end of infusion. Cohort 2: predose, immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion ]

7.  Primary:   PK: Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0-∞)] of Necitumumab After a Single Dose   [ Time Frame: Cycle 1, Day 1; Cohorts 1 and 3: predose, immediately after end of infusion, 0.5, 1, 2, 6, 24, 96 and 168 h after end of infusion. Cohort 2: predose, immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion ]

8.  Primary:   PK: Area Under the Concentration-Time Curve From Time 0 to 336 h Postdose [AUC(0-336)] of Necitumumab After Multiple Doses   [ Time Frame: Cycle 1, Day 29; For Cohorts 1, 2 and 3: predose (prior to fourth infusion for Cohorts 1 and 3; prior to third infusion for Cohort 2), immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion ]

9.  Primary:   PK: Half-Life (t½) of Necitumumab After a Single Dose   [ Time Frame: Cycle 1, Day 1; Cohorts 1 and 3: predose, immediately after end of infusion, 0.5, 1, 2, 6, 24, 96 and 168 h after end of infusion. Cohort 2: predose, immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion ]

10.  Primary:   PK: t½ of Necitumumab After Multiple Doses   [ Time Frame: Cycle 1, Day 29; For Cohorts 1, 2 and 3: predose (prior to fourth infusion for Cohorts 1 and 3; prior to third infusion for Cohort 2), immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion ]

11.  Primary:   PK: Clearance (CL) of Necitumumab After a Single Dose   [ Time Frame: Cycle 1, Day 1; Cohorts 1 and 3: predose, immediately after end of infusion, 0.5, 1, 2, 6, 24, 96 and 168 h after end of infusion. Cohort 2: predose, immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion ]

12.  Primary:   PK: CL of Necitumumab After Multiple Doses   [ Time Frame: Cycle 1, Day 29; For Cohorts 1, 2 and 3: predose (prior to fourth infusion for Cohorts 1 and 3; prior to third infusion for Cohort 2), immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion ]

13.  Primary:   PK: Steady-State Volume of Distribution (Vss) of Necitumumab After Single Dose   [ Time Frame: Cycle 1, Day 1; Cohorts 1 and 3: predose, immediately after end of infusion, 0.5, 1, 2, 6, 24, 96 and 168 h after end of infusion. Cohort 2: predose, immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion ]

14.  Primary:   PK: Vss of Necitumumab After Multiple Doses   [ Time Frame: Cycle 1, Day 29; For Cohorts 1, 2 and 3: predose (prior to fourth infusion for Cohorts 1 and 3; prior to third infusion for Cohort 2), immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion ]

15.  Secondary:   Immunogenicity (IK): Number of Participants With Treatment-Emergent Anti-IMC-11F8 Antibodies   [ Time Frame: For Cohorts 1, 2 and 3: Prior to first infusions of Cycles 1, 2, and 4 and at the 30-day follow-up visit (+7 days) after the last dose of study drug ]


  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
No text entered.


  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



Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01088464     History of Changes
Other Study ID Numbers: 13904
CP11-0907 ( Other Identifier: ImClone Systems )
I4X-IE-JFCA ( Other Identifier: Eli Lilly )
21-1901 ( Other Identifier: PMDA (MoH) in Japan )
Study First Received: March 16, 2010
Results First Received: December 21, 2015
Last Updated: December 9, 2016