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Trial record 7 of 130 for:    IK

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01088464
Recruitment Status : Completed
First Posted : March 17, 2010
Results First Posted : February 3, 2017
Last Update Posted : February 3, 2017
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
Eli Lilly and Company

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
Enrollment 15
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Cohort 1: Necitumumab Cohort 2: Necitumumab Cohort 3: Necitumumab
Hide Arm/Group Description 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. 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. 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.
Period Title: Overall Study
Started 3 6 6
Received Any Quantity of Study Drug 3 6 6
Completed 3 6 6
Not Completed 0 0 0
Arm/Group Title Cohort 1: Necitumumab Cohort 2: Necitumumab Cohort 3: Necitumumab Total
Hide Arm/Group Description 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 3 6 6 15
Hide Baseline Analysis Population Description
All enrolled participants who received any quantity of study drug.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants 6 participants 6 participants 15 participants
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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 6 participants 6 participants 15 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  
Measure Type: Number
Unit of measure:  Participants
Japanese Number Analyzed 3 participants 6 participants 6 participants 15 participants
3 6 6 15
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 3 participants 6 participants 6 participants 15 participants
3 6 6 15
Eastern Cooperative Oncology Group performance status (ECOG PS)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 6 participants 6 participants 15 participants
0 = Fully Active 1 1 4 6
1 = Ambulatory, Restricted Work Activity 2 5 2 9
[1]
Measure Description: 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.
1.Primary Outcome
Title Number of Participants With 1 or More Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)
Hide Description Data presented are the number of participants who experienced 1 or more TEAEs or SAEs regardless of causality. An adverse event was considered as TEAE if it occurred any time after the administration of the first dose of study drug or up to 30 days after the last dose of study treatment or if it occurred prior to the first dose and worsened while on treatment. A summary of SAEs and other non-SAEs regardless of causality is located in the Reported Adverse Events module.
Time Frame Baseline up to 24 weeks plus 30 days post last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received any quantity of study drug.
Arm/Group Title Cohort 1: Necitumumab Cohort 2: Necitumumab Cohort 3: Necitumumab
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 3 6 6
Measure Type: Number
Unit of Measure: participants
TEAEs 3 6 6
SAEs 1 0 1
2.Primary Outcome
Title Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Necitumumab After a Single Dose
Hide Description [Not Specified]
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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received single dose of study drug and had Cmax values for Day 1 of Cycle 1.
Arm/Group Title Cohort 1: Necitumumab Cohort 2: Necitumumab Cohort 3: Necitumumab
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 3 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: micrograms per milliliter (µg/mL)
306
(29%)
417
(46%)
352
(20%)
3.Primary Outcome
Title PK: Cmax of Necitumumab After Multiple Doses
Hide Description Cmax at steady state (after the last dose of the initial 6-week treatment cycle).
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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received multiple doses of study drug and had Cmax values for Day 29 of Cycle 1.
Arm/Group Title Cohort 1: Necitumumab Cohort 2: Necitumumab Cohort 3: Necitumumab
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 3 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/mL
396
(5%)
523
(17%)
629
(16%)
4.Primary Outcome
Title PK: Minimum Concentration (Cmin) of Necitumumab After a Single Dose
Hide Description Cmin is defined as the minimum concentration the drug achieved after administration of first infusion and prior to the administration of second infusion.
Time Frame Cycle 1; Cohorts 1, 2 and 3: prior to second infusion
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received single dose of study drug and had Cmin serum concentrations analyzed prior to administration of second dose.
Arm/Group Title Cohort 1: Necitumumab Cohort 2: Necitumumab Cohort 3: Necitumumab
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 3 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/mL
86.0
(10%)
72.9
(24%)
127
(18%)
5.Primary Outcome
Title PK: Cmin of Necitumumab After Multiple Doses
Hide Description Cmin was calculated prior to the last dose of the initial 6-week treatment cycle.
Time Frame Cycle 1; Cohorts 1and 3: prior to fourth infusion. Cohort 2: prior to third infusion
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received multiple doses of study drug and had Cmin serum concentrations prior to last dose of Cycle 1.
Arm/Group Title Cohort 1: Necitumumab Cohort 2: Necitumumab Cohort 3: Necitumumab
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 3 6 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/mL
108
(23%)
136
(22%)
220
(16%)
6.Primary Outcome
Title PK: Area Under the Concentration-Time Curve From Time 0 to Last Time Point [AUC (0-tlast)] of Necitumumab After a Single Dose
Hide Description [Not Specified]
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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received single dose of study drug and had evaluable AUC(0-∞) values for Day 1 of Cycle 1.
Arm/Group Title Cohort 1: Necitumumab Cohort 2: Necitumumab Cohort 3: Necitumumab
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 3 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: micrograms*hour/milliliter (µg*h/mL)
23100
(16%)
50100
(24%)
31300
(17%)
7.Primary Outcome
Title PK: Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0-∞)] of Necitumumab After a Single Dose
Hide Description AUC(0-∞) was calculated only for participants in Cohort 2 as the percentage of AUC extrapolated beyond tlast was greater than 30% for all the remaining participants.
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
Hide Outcome Measure Data
Hide Analysis Population Description

All participants who received single dose of study drug and had evaluable AUC(0-∞) values for Day

1 of Cycle 1. No participant of Cohorts 1 and 3 were analyzed for AUC(0-∞) on Day 1 of Cycle 1, due to fraction of data outside tlast >30%

Arm/Group Title Cohort 1: Necitumumab Cohort 2: Necitumumab Cohort 3: Necitumumab
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 0 3 0
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg*h/mL
66700
(21%)
8.Primary Outcome
Title PK: Area Under the Concentration-Time Curve From Time 0 to 336 h Postdose [AUC(0-336)] of Necitumumab After Multiple Doses
Hide Description Steady state AUC(0-336) values are reported.
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
Hide Outcome Measure Data
Hide Analysis Population Description
All the participants who received multiple doses of study drug and had AUC(0-336) values for Day 29 of Cycle 1.
Arm/Group Title Cohort 1: Necitumumab Cohort 2: Necitumumab Cohort 3: Necitumumab
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 3 6 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg*h/mL
56300
(21%)
81400
(19%)
105000
(12%)
9.Primary Outcome
Title PK: Half-Life (t½) of Necitumumab After a Single Dose
Hide Description The t½ is defined as the time taken for study drug in blood to decrease to half of its concentration.
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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received single dose of study drug and had t½ values for Day 1 of Cycle 1.
Arm/Group Title Cohort 1: Necitumumab Cohort 2: Necitumumab Cohort 3: Necitumumab
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 3 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h
126
(14%)
207
(31%)
146
(18%)
10.Primary Outcome
Title PK: t½ of Necitumumab After Multiple Doses
Hide Description The t½ is defined as the time taken for study drug in blood to decrease to half of its concentration.
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
Hide Outcome Measure Data
Hide Analysis Population Description
All the participants who received multiple doses of study drug and had t½ values for Day 29 of Cycle 1.
Arm/Group Title Cohort 1: Necitumumab Cohort 2: Necitumumab Cohort 3: Necitumumab
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 3 5 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h
190
(36%)
233
(18%)
286
(18%)
11.Primary Outcome
Title PK: Clearance (CL) of Necitumumab After a Single Dose
Hide Description CL is defined as the volume of plasma that is cleared of study drug per unit time. CL was not analyzed for participants in Cohorts 1 and 3 as CL is derived from AUC(0-∞). AUC(0-∞) was calculated only for participants in Cohort 2 as the percentage of AUC extrapolated beyond tlast was greater than 30% for the remaining participants.
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
Hide Outcome Measure Data
Hide Analysis Population Description
All the participants who received single dose of study drug and had CL values for Day 1 of Cycle 1. No participant of Cohorts 1 and 3 were analyzed for CL on Day 1 of Cycle 1, due to fraction of data outside tlast >30%
Arm/Group Title Cohort 1: Necitumumab Cohort 2: Necitumumab Cohort 3: Necitumumab
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 0 3 0
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: milliliters per hour (mL/h)
12.0
(21%)
12.Primary Outcome
Title PK: CL of Necitumumab After Multiple Doses
Hide Description CL is defined as the volume of plasma that is cleared of study drug per unit time. Data did not allow calculation of CL for participants in Cohorts 1 and 3.
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
Hide Outcome Measure Data
Hide Analysis Population Description
All the participants who received multiple doses of study drug and had CL values for Day 29 of Cycle 1. CL of necitumumab was not assessed for participants in Cohorts 1 and 3, due to the irregular dosing regimen.
Arm/Group Title Cohort 1: Necitumumab Cohort 2: Necitumumab Cohort 3: Necitumumab
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 0 6 0
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL/h
9.83
(19%)
13.Primary Outcome
Title PK: Steady-State Volume of Distribution (Vss) of Necitumumab After Single Dose
Hide Description Vss is that amount of plasma in which the study drug needs to be dissolved to attain a steady state drug concentration. Vss was not analyzed for participants in Cohorts 1 and 3 as Vss is derived from AUC (0-∞). AUC(0-∞) was calculated only for participants in Cohort 2 as the percentage of AUC extrapolated beyond tlast was greater than 30% for the remaining participants.
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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received single dose of study drug and had Vss values for Day 1 of Cycle 1. Vss of necitumumab was not assessed for participants in Cohorts 1 and 3, due to the irregular dosing regimen.
Arm/Group Title Cohort 1: Necitumumab Cohort 2: Necitumumab Cohort 3: Necitumumab
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 0 3 0
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: milliliters (mL)
2780
(31%)
14.Primary Outcome
Title PK: Vss of Necitumumab After Multiple Doses
Hide Description Vss is that amount of plasma in which the study drug needs to be dissolved to attain a steady state drug concentration. Data did not allow calculation of Vss for participants in Cohorts 1 and 3.
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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received multiple doses of study drug and had Vss values for Day 29 of Cycle 1. Vss of necitumumab was not assessed for participants in Cohorts 1 and 3, due to the irregular dosing regimen.
Arm/Group Title Cohort 1: Necitumumab Cohort 2: Necitumumab Cohort 3: Necitumumab
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 0 5 0
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL
3370
(21%)
15.Secondary Outcome
Title Immunogenicity (IK): Number of Participants With Treatment-Emergent Anti-IMC-11F8 Antibodies
Hide Description Treatment-emergent samples were defined as samples which showed at least 4-fold difference (2 dilution increase) at post-baseline in IK titer over the baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20).
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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received any quantity of study drug.
Arm/Group Title Cohort 1: Necitumumab Cohort 2: Necitumumab Cohort 3: Necitumumab
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 3 6 6
Measure Type: Number
Unit of Measure: participants
Positive for Anti-Necitumumab Antibodies 0 0 0
Negative for Anti-Necitumumab Antibodies 3 6 6
Time Frame Baseline up to 24 weeks plus 30 days post last dose of study drug
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort 1: Necitumumab Cohort 2: Necitumumab Cohort 3: Necitumumab
Hide Arm/Group Description 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. 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. 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.
All-Cause Mortality
Cohort 1: Necitumumab Cohort 2: Necitumumab Cohort 3: Necitumumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1: Necitumumab Cohort 2: Necitumumab Cohort 3: Necitumumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/3 (33.33%)      0/6 (0.00%)      1/6 (16.67%)    
Hepatobiliary disorders       
Hepatic function abnormal  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Oropharyngeal discomfort  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort 1: Necitumumab Cohort 2: Necitumumab Cohort 3: Necitumumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      6/6 (100.00%)      6/6 (100.00%)    
Blood and lymphatic system disorders       
Eosinophilia  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Neutropenia  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Cardiac disorders       
Palpitations  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Sinus bradycardia  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Ear and labyrinth disorders       
Vertigo  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Eye disorders       
Dry eye  1  1/3 (33.33%)  2 1/6 (16.67%)  1 0/6 (0.00%)  0
Eye discharge  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Gastrointestinal disorders       
Abdominal discomfort  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Abdominal pain upper  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Anal haemorrhage  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Cheilitis  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  2
Constipation  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Diarrhoea  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Dysphagia  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Gingivitis  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Lip dry  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Nausea  1  1/3 (33.33%)  3 2/6 (33.33%)  4 3/6 (50.00%)  5
Stomatitis  1  1/3 (33.33%)  1 4/6 (66.67%)  5 2/6 (33.33%)  2
Vomiting  1  0/3 (0.00%)  0 1/6 (16.67%)  1 2/6 (33.33%)  2
General disorders       
Face oedema  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Fatigue  1  1/3 (33.33%)  2 2/6 (33.33%)  3 1/6 (16.67%)  1
Pyrexia  1  1/3 (33.33%)  1 2/6 (33.33%)  4 3/6 (50.00%)  3
Infections and infestations       
Candidiasis  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Cystitis  1  0/3 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1
Enterocolitis infectious  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Paronychia  1  0/3 (0.00%)  0 2/6 (33.33%)  2 1/6 (16.67%)  1
Pharyngitis  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Pneumonia  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Injury, poisoning and procedural complications       
Arthropod sting  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Investigations       
Alanine aminotransferase increased  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  2
Aspartate aminotransferase increased  1  1/3 (33.33%)  1 0/6 (0.00%)  0 1/6 (16.67%)  2
Blood alkaline phosphatase increased  1  0/3 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1
Blood amylase increased  1  0/3 (0.00%)  0 2/6 (33.33%)  3 0/6 (0.00%)  0
Blood bilirubin increased  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Blood potassium increased  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Glucose urine present  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Weight decreased  1  1/3 (33.33%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0
White blood cell count decreased  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Metabolism and nutrition disorders       
Anorexia  1  1/3 (33.33%)  2 3/6 (50.00%)  4 3/6 (50.00%)  5
Dehydration  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Hyperglycaemia  1  0/3 (0.00%)  0 1/6 (16.67%)  1 2/6 (33.33%)  2
Hypoalbuminaemia  1  2/3 (66.67%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0
Hypomagnesaemia  1  1/3 (33.33%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1
Musculoskeletal and connective tissue disorders       
Arthralgia  1  0/3 (0.00%)  0 2/6 (33.33%)  4 1/6 (16.67%)  1
Musculoskeletal pain  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Myalgia  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Nervous system disorders       
Akathisia  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Dysarthria  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Headache  1  2/3 (66.67%)  2 5/6 (83.33%)  6 4/6 (66.67%)  4
Myoclonus  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Psychiatric disorders       
Insomnia  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Renal and urinary disorders       
Proteinuria  1  1/3 (33.33%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Asthma  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Nasal discomfort  1  1/3 (33.33%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0
Oropharyngeal discomfort  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Oropharyngeal pain  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Pleural effusion  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Skin and subcutaneous tissue disorders       
Acne  1  0/3 (0.00%)  0 2/6 (33.33%)  4 3/6 (50.00%)  6
Dry skin  1  1/3 (33.33%)  1 4/6 (66.67%)  5 5/6 (83.33%)  8
Nail disorder  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Palmar-plantar erythrodysaesthesia syndrome  1  0/3 (0.00%)  0 0/6 (0.00%)  0 3/6 (50.00%)  4
Periorbital oedema  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Pruritus  1  3/3 (100.00%)  4 3/6 (50.00%)  4 3/6 (50.00%)  5
Rash  1  3/3 (100.00%)  4 3/6 (50.00%)  7 2/6 (33.33%)  6
Rash generalised  1  0/3 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  2
Urticaria  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Vascular disorders       
Flushing  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Hot flush  1  0/3 (0.00%)  0 1/6 (16.67%)  1 2/6 (33.33%)  9
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
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.
Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study completion or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.
Results Point of Contact
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Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
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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 )
First Submitted: March 16, 2010
First Posted: March 17, 2010
Results First Submitted: December 21, 2015
Results First Posted: February 3, 2017
Last Update Posted: February 3, 2017