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Trial record 1 of 1 for:    Necitumumab, CP11-1115
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A Drug-Interaction Study of Necitumumab (IMC-11F8) in Combination With Gemcitabine-Cisplatin

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: NCT01606748
Recruitment Status : Completed
First Posted : May 28, 2012
Results First Posted : August 26, 2016
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Malignant Solid Tumor
Interventions Biological: Necitumumab
Drug: Gemcitabine
Drug: Cisplatin
Enrollment 35
Recruitment Details  
Pre-assignment Details Cohort 1 'completers' completed the PK run-in period (3 Weeks) and Cycle 1, Day 1 and Cohort 2 'completers' completed the PK run-in period.
Arm/Group Title Necitumumab Cohort 1 Necitumumab Cohort 2
Hide Arm/Group Description

Necitumumab administered on Day 3 of the 3-week PK run-in period as an intravenous (IV) infusion at an absolute dose of 800 milligrams (mg). Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.

Participants in Cohort 1 received necitumumab Process C drug product. Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/square meter (m2).

Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2.

Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.

Participants in Cohort 2 received necitumumab drug product manufactured using a new and comparable necitumumab drug substance (Process D drug product).

Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.

Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2.

Period Title: Overall Study
Started 18 17
Received at Least 1 Dose of Study Drug 18 17
Completed 15 17
Not Completed 3 0
Reason Not Completed
Adverse Event             1             0
Progressive Disease             1             0
Withdrawal by Subject             1             0
Arm/Group Title Necitumumab Cohort 1 Necitumumab Cohort 2 Total
Hide Arm/Group Description

Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.

Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.

Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.

Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2.

Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.

Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.

Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.

Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2.

Total of all reporting groups
Overall Number of Baseline Participants 18 17 35
Hide Baseline Analysis Population Description
All participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 17 participants 35 participants
55.3  (15.54) 58.2  (13.84) 56.7  (14.59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 17 participants 35 participants
Female
11
  61.1%
10
  58.8%
21
  60.0%
Male
7
  38.9%
7
  41.2%
14
  40.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 17 participants 35 participants
Hispanic or Latino
1
   5.6%
1
   5.9%
2
   5.7%
Not Hispanic or Latino
17
  94.4%
16
  94.1%
33
  94.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 17 participants 35 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   5.6%
0
   0.0%
1
   2.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
3
  17.6%
3
   8.6%
White
17
  94.4%
14
  82.4%
31
  88.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants 17 participants 35 participants
18 17 35
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) at Baseline   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants 17 participants 35 participants
0 9 7 16
1 9 10 19
>=2 0 0 0
[1]
Measure Description: Classifies participants according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death). 0 - Fully Active. 1 - Ambulatory, Restricted Strenuous Activity. 2 - Ambulatory, No Work Activities. 3 - Partially Confined to Bed, Limited Self Care. 4 - Completely Disabled. 5 - Death.
Disease Characteristics - Tumor Type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants 17 participants 35 participants
Breast Carcinoma 3 4 7
Ovarian Carcinoma 2 1 3
Small Cell Lung Carcinoma 2 1 3
Thymic Tumor 2 0 2
Nonsmall Cell Lung Carcinoma 2 0 2
Melanoma 1 1 2
Head and Neck Carcinoma 1 1 2
Endometrial Carcinoma 1 1 2
Hepatobilliary Carcinoma 1 0 1
Left Parotid 1 0 1
Liver 1 0 1
Granulosa Cell Tumor of the Ovary 1 0 1
Mesothelioma 0 1 1
Neuroendocrine Tumor 0 1 1
Hepatocellular Carcinoma 0 1 1
Esophageal Carcinoma 0 1 1
Colorectal Carcinoma 0 1 1
Sarcoma, soft tissue 0 1 1
Adenocarcinoma of the Ampula of Vater 0 1 1
Pancreatic Carcinoma 0 1 1
Prior Anti-Cancer Therapy   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants 17 participants 35 participants
Any Prior Radiotherapy 13 10 23
Any Prior (Adjuvant/Neoadjuvant) Systemic Therapy 17 16 33
[1]
Measure Description: Not all participants received prior anti-cancer therapy.
1.Primary Outcome
Title Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Necitumumab
Hide Description [Not Specified]
Time Frame Run-In Period Day 3 Cohort 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 Hour (h) Post Start of Infusion; Cycle 1, Day 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had evaluable data for PK.
Arm/Group Title Necitumumab Cohort 1 Day 3 Run-in Necitumumab Cohort 1 Day 1, Cycle 1, Combination
Hide Arm/Group Description:
Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Participants in Cohort 1 received necitumumab Process C drug product.
Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg. Participants in Cohort 1 received necitumumab Process C drug product.
Overall Number of Participants Analyzed 18 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: microgram/milliliter (ug/mL)
277
(22%)
315
(23%)
2.Primary Outcome
Title PK: Dose-Normalized Cmax of Gemcitabine
Hide Description [Not Specified]
Time Frame Run-In Period Day 1 Cohort 1: 0,0.5,1,1.5,3,4,6.67 and 24h Post Start of Infusion; Cycle 1, Day 1: 0, 0.50, 1, 1.5, 3, 4.67, 6.67 and 24 h Post Start of Infusion
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had evaluable data for PK. Per protocol, no data were collected for this assessment for participants in Cohort 2.
Arm/Group Title Gemcitabine Cohort 1 Day 1 PK Run-In Gemcitabine Cohort 1 Day 1, Cycle 1, Combination
Hide Arm/Group Description:
Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.
Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2.
Overall Number of Participants Analyzed 18 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram(ng)/mL/mg
4.83
(66%)
7.87
(43%)
3.Primary Outcome
Title PK: Dose-Normalized Cmax of Cisplatin
Hide Description [Not Specified]
Time Frame Run-In Period Day 1 Cohort 1: 0, 2, 2.03, 2.25, 3, 3.67 and 5.67 h Post Start of Infusion; Cycle 1, Day 1: 0, 2, 2.03, 2.25, 3, 3.67 and 5.67 h Post Start of Infusion
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had evaluable data for PK. Per protocol, no data were collected for this assessment for participants in Cohort 2.
Arm/Group Title Cisplatin Cohort 1 Day 1 Run-in Cisplatin Cohort 1 Day 1, Cycle 1, Combination
Hide Arm/Group Description:
Cisplatin administered on Day 1 of the 3-week PK run-in period as an IV infusion of 75 mg/m2.
Cisplatin administered 75 mg/m2 on Days 1 and 8 of every 3-week cycle as an IV infusion.
Overall Number of Participants Analyzed 18 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram (ng)/mL/mg
19.2
(21%)
22.1
(30%)
4.Primary Outcome
Title PK: Area Under Concentration-Time Curve From Zero to Time 168 (AUC[-168]) of Necitumumab
Hide Description [Not Specified]
Time Frame Run-In Period Day 3 Cohort 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion; Cycle 1, Day 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had evaluable data for PK. Per protocol, no data were collected for this assessment for participants in Cohort 2.
Arm/Group Title Necitumumab Cohort 1 Day 3 Run-In Necitumumab Cohort 1 Day 1, Cycle 1, Combination
Hide Arm/Group Description:
Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg.
Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.
Overall Number of Participants Analyzed 18 11
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ug*hour(h)/mL
21900
(24%)
22900
(34%)
5.Primary Outcome
Title PK: Dose-Normalized AUC(0-24) of Gemcitabine
Hide Description [Not Specified]
Time Frame Run-In Period Day 1 Cohort 1: 0,0.5,1,1.5,3,4,6.67 and 24h Post Start of Infusion; Cycle 1, Day 1: 0, 0.50, 1, 1.5, 3, 4.67, 6.67 and 24 h Post Start of Infusion
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had evaluable data for PK. Per protocol, no data were collected for this assessment for participants in Cohort 2.
Arm/Group Title Gemcitabine Cohort 1 Day 1 PK Run-in Gemcitabine Cohort 1 Day 1, Cycle 1, Combination
Hide Arm/Group Description:
Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.
Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2.
Overall Number of Participants Analyzed 17 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL/mg
2.71
(45%)
3.31
(33%)
6.Primary Outcome
Title PK: Dose-Normalized AUC(0-5) of Cisplatin
Hide Description [Not Specified]
Time Frame Run-In Period Day 1 Cohort 1: 0, 2, 2.03, 2.25, 3, 3.67 and 5.67 h Post Start of Infusion; Cycle 1, Day 1: 0, 2, 2.03, 2.25, 3, 3.67 and 5.67 h Post Start of Infusion
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had evaluable data for PK. Per protocol, no data were collected for this assessment for participants in Cohort 2.
Arm/Group Title Cisplatin Cohort 1 Day 1 Run-in Cisplatin Cohort 1 Day 1, Cycle 1, Combination
Hide Arm/Group Description:
Cisplatin administered on Day 1 of the 3-week PK run-in period as an IV infusion of 75 mg/m2.
Cisplatin administered 75 mg/m2 on Days 1 and 8 of every 3-week cycle as an IV infusion.
Overall Number of Participants Analyzed 17 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL/mg
61.5
(20%)
67.3
(24%)
7.Primary Outcome
Title PK: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity, (AUC[0-∞]) of Necitumumab
Hide Description [Not Specified]
Time Frame Run-In Period Day 3 Cohort 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion; Cycle 1 Day 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had evaluable data for PK.
Arm/Group Title Necitumumab Cohort 1 Day 3 PK Run-In Necitumumab Cohort 1 Day 1, Cycle 1, Combination
Hide Arm/Group Description:
Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg.
Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.
Overall Number of Participants Analyzed 14 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ug*h/mL
33800
(33%)
26400
(30%)
8.Primary Outcome
Title PK: Dose Normalized AUC(0-∞) of Gemcitabine
Hide Description [Not Specified]
Time Frame Run-In Period Day 1 Cohort 1: 0,0.5,1,1.5,3,4,6.67 and 24h Post Start of Infusion; Cycle 1, Day 1: 0, 0.50, 1, 1.5, 3, 4.67, 6.67 and 24 h Post Start of Infusion
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had evaluable data for PK. Per protocol, no data were collected for this assessment for participants in Cohort 2.
Arm/Group Title Gemcitabine Cohort 1 Day 1 PK Run-in Gemcitabine Cohort 1 Day 1, Cycle 1, Combination
Hide Arm/Group Description:
Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.
Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2.
Overall Number of Participants Analyzed 17 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL/mg
2.72
(45%)
3.32
(33%)
9.Secondary Outcome
Title Number of Participants With Anti-Necitumumab Antibodies
Hide Description A participant was considered to have an anti-necitumumab antibody response if anti-drug antibodies (ADA) were confirmed positive. Treatment emergent antibodies were defined as any anti-necitumumab antibody titer equal to or greater than 4-fold the participant's baseline titer.
Time Frame Baseline through, 30-Day Follow-Up
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had evaluable baseline and postbaseline data for antibodies.
Arm/Group Title Necitumumab Cohort 1 Necitumumab Cohort 2
Hide Arm/Group Description:

Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.

Participants in Cohort 1 received necitumumab Process C drug product. Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.

Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2.

Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.

Participants in Cohort 2 received necitumumab Process D drug product.

Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.

Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2.

Overall Number of Participants Analyzed 18 17
Measure Type: Number
Unit of Measure: participants with immunogenicity samples
ADA Positive 3 0
TE Antibodies 1 0
Neutralizing Antibodies 0 0
10.Secondary Outcome
Title Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR]) (Antitumor Activity of Necitumumab in Combination With Gemcitabine-cisplatin Chemotherapy)
Hide Description ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, CR was defined as the disappearance of all target and non-target lesions; PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) * 100.
Time Frame Baseline to Measured Progressive Disease (Up to 14 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug.
Arm/Group Title Necitumumab Cohort 1 Necitumumab Cohort 2
Hide Arm/Group Description:

Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.

Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.

Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.

Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2.

Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.

Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.

Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.

Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2.

Overall Number of Participants Analyzed 18 17
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
16.7
(3.6 to 41.4)
5.9
(0.1 to 28.7)
11.Secondary Outcome
Title PK: Cmax of Necitumumab After Administration of Process C and Process D Drug Product
Hide Description [Not Specified]
Time Frame Run-In Period Day 3 Cohort 1 and Cohort 2: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had evaluable data for PK.
Arm/Group Title Necitumumab Cohort 1 Necitumumab Cohort 2
Hide Arm/Group Description:

Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.

Participants in Cohort 1 received necitumumab Process C drug product. Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.

Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2.

Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.

Participants in Cohort 2 received necitumumab Process D drug product.

Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.

Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2.

Overall Number of Participants Analyzed 18 17
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ug/mL
277
(22%)
300
(36%)
12.Secondary Outcome
Title PK: AUC(0-∞) of Necitumumab After Administration of Process C and Process D Drug Product
Hide Description [Not Specified]
Time Frame Run-In Period Day 3 Cohort 1 and Cohort 2: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had evaluable data for PK.
Arm/Group Title Necitumumab Cohort 1 Necitumumab Cohort 2
Hide Arm/Group Description:

Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.

Participants in Cohort 1 received necitumumab Process C drug product. Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.

Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2.

Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.

Participants in Cohort 2 received necitumumab Process D drug product.

Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.

Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2.

Overall Number of Participants Analyzed 14 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ug*h/mL
33800
(33%)
35500
(35%)
Time Frame [Not Specified]
Adverse Event Reporting Description All participants who received at least one dose of study drug.
 
Arm/Group Title Necitumumab Cohort 1 Necitumumab Cohort 2
Hide Arm/Group Description

Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.

Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.

Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.

Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2.

Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.

Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.

Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.

Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2.

All-Cause Mortality
Necitumumab Cohort 1 Necitumumab Cohort 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Necitumumab Cohort 1 Necitumumab Cohort 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/18 (27.78%)      8/17 (47.06%)    
Blood and lymphatic system disorders     
Anaemia  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Febrile neutropenia  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Pancytopenia  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Thrombocytopenia  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Cardiac disorders     
Acute myocardial infarction  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Eye disorders     
Eye pain  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Gastrointestinal disorders     
Diarrhoea  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Intestinal obstruction  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Nausea  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Small intestinal obstruction  1  0/18 (0.00%)  0 1/17 (5.88%)  1
General disorders     
Asthenia  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Pyrexia  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Infections and infestations     
Catheter site infection  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Implant site cellulitis  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Sepsis  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Skin infection  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Staphylococcal infection  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Urinary tract infection bacterial  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Injury, poisoning and procedural complications     
Fall  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Metabolism and nutrition disorders     
Decreased appetite  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Dehydration  1  0/18 (0.00%)  0 2/17 (11.76%)  2
Hypokalaemia  1  0/18 (0.00%)  0 1/17 (5.88%)  3
Hypomagnesaemia  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Nervous system disorders     
Cerebral ischaemia  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Ischaemic stroke  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Presyncope  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Renal and urinary disorders     
Renal failure acute  1  0/18 (0.00%)  0 1/17 (5.88%)  2
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Epistaxis  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Hypoxia  1  0/18 (0.00%)  0 1/17 (5.88%)  2
Pulmonary embolism  1  1/18 (5.56%)  1 1/17 (5.88%)  1
Vascular disorders     
Hypertension  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Necitumumab Cohort 1 Necitumumab Cohort 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/18 (100.00%)      17/17 (100.00%)    
Blood and lymphatic system disorders     
Anaemia  1  10/18 (55.56%)  51 13/17 (76.47%)  50
Anisocytosis  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Leukocytosis  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Leukopenia  1  2/18 (11.11%)  8 5/17 (29.41%)  14
Lymphopenia  1  2/18 (11.11%)  2 4/17 (23.53%)  10
Macrocytosis  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Microcytosis  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Neutropenia  1  8/18 (44.44%)  25 9/17 (52.94%)  18
Thrombocytopenia  1  11/18 (61.11%)  25 6/17 (35.29%)  26
Cardiac disorders     
Palpitations  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Tachycardia  1  0/18 (0.00%)  0 2/17 (11.76%)  2
Ear and labyrinth disorders     
Cerumen impaction  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Deafness  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Ear pain  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Tinnitus  1  5/18 (27.78%)  6 1/17 (5.88%)  1
Eye disorders     
Asthenopia  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Dry eye  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Eye irritation  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Eye pain  1  2/18 (11.11%)  2 0/17 (0.00%)  0
Growth of eyelashes  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Lacrimation increased  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Periorbital oedema  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Photophobia  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Photopsia  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Trichiasis  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Vision blurred  1  2/18 (11.11%)  2 3/17 (17.65%)  3
Visual acuity reduced  1  0/18 (0.00%)  0 2/17 (11.76%)  2
Visual impairment  1  1/18 (5.56%)  1 1/17 (5.88%)  1
Gastrointestinal disorders     
Abdominal discomfort  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Abdominal distension  1  0/18 (0.00%)  0 5/17 (29.41%)  5
Abdominal pain  1  1/18 (5.56%)  1 3/17 (17.65%)  5
Abdominal pain upper  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Ascites  1  0/18 (0.00%)  0 1/17 (5.88%)  2
Cheilitis  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Constipation  1  7/18 (38.89%)  7 6/17 (35.29%)  13
Diarrhoea  1  6/18 (33.33%)  9 7/17 (41.18%)  11
Dry mouth  1  0/18 (0.00%)  0 4/17 (23.53%)  4
Duodenal ulcer  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Dyspepsia  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Dysphagia  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Gastrooesophageal reflux disease  1  2/18 (11.11%)  2 2/17 (11.76%)  2
Gingival bleeding  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Glossodynia  1  2/18 (11.11%)  2 0/17 (0.00%)  0
Haematochezia  1  0/18 (0.00%)  0 1/17 (5.88%)  2
Haemorrhoids  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Lip disorder  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Nausea  1  12/18 (66.67%)  15 10/17 (58.82%)  26
Oral pain  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Sensitivity of teeth  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Stomatitis  1  1/18 (5.56%)  1 1/17 (5.88%)  1
Stomatitis necrotising  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Vomiting  1  10/18 (55.56%)  13 6/17 (35.29%)  16
General disorders     
Asthenia  1  1/18 (5.56%)  2 1/17 (5.88%)  1
Catheter site haemorrhage  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Catheter site pain  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Chills  1  1/18 (5.56%)  1 3/17 (17.65%)  4
Device deployment issue  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Device leakage  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Fatigue  1  14/18 (77.78%)  19 13/17 (76.47%)  28
Gait disturbance  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Implant site erythema  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Implant site irritation  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Mucosal dryness  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Mucosal inflammation  1  0/18 (0.00%)  0 2/17 (11.76%)  2
Non-cardiac chest pain  1  0/18 (0.00%)  0 2/17 (11.76%)  2
Oedema  1  1/18 (5.56%)  1 1/17 (5.88%)  1
Oedema peripheral  1  0/18 (0.00%)  0 2/17 (11.76%)  5
Pain  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Pyrexia  1  1/18 (5.56%)  1 3/17 (17.65%)  4
Tenderness  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Immune system disorders     
Multiple allergies  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Infections and infestations     
Abscess neck  1  1/18 (5.56%)  2 0/17 (0.00%)  0
Abscess oral  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Bronchitis  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Cellulitis orbital  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Fungal skin infection  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Hand-foot-and-mouth disease  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Herpes zoster  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Oral herpes  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Paronychia  1  1/18 (5.56%)  4 0/17 (0.00%)  0
Rash pustular  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Sinusitis  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Upper respiratory tract infection  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Urinary tract infection  1  1/18 (5.56%)  1 3/17 (17.65%)  6
Injury, poisoning and procedural complications     
Excoriation  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Fall  1  0/18 (0.00%)  0 1/17 (5.88%)  3
Gastrostomy failure  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Infusion related reaction  1  1/18 (5.56%)  1 1/17 (5.88%)  2
Laceration  1  1/18 (5.56%)  1 1/17 (5.88%)  1
Procedural pain  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Wound  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Investigations     
Activated partial thromboplastin time prolonged  1  1/18 (5.56%)  1 6/17 (35.29%)  7
Alanine aminotransferase decreased  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Alanine aminotransferase increased  1  8/18 (44.44%)  15 5/17 (29.41%)  7
Aspartate aminotransferase increased  1  11/18 (61.11%)  16 8/17 (47.06%)  12
Blood albumin decreased  1  0/18 (0.00%)  0 1/17 (5.88%)  2
Blood alkaline phosphatase increased  1  4/18 (22.22%)  9 2/17 (11.76%)  5
Blood bilirubin increased  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Blood cholesterol increased  1  1/18 (5.56%)  1 3/17 (17.65%)  3
Blood creatine phosphokinase increased  1  4/18 (22.22%)  4 1/17 (5.88%)  1
Blood creatinine increased  1  4/18 (22.22%)  11 5/17 (29.41%)  15
Blood fibrinogen increased  1  2/18 (11.11%)  2 2/17 (11.76%)  2
Blood magnesium decreased  1  3/18 (16.67%)  3 0/17 (0.00%)  0
Blood magnesium increased  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Blood potassium decreased  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Blood urea increased  1  4/18 (22.22%)  9 3/17 (17.65%)  3
Blood uric acid increased  1  0/18 (0.00%)  0 1/17 (5.88%)  2
Blood urine present  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Carbohydrate antigen 125 increased  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Carbohydrate antigen 19-9 increased  1  0/18 (0.00%)  0 2/17 (11.76%)  2
Carcinoembryonic antigen increased  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Fibrin d dimer increased  1  5/18 (27.78%)  6 2/17 (11.76%)  3
Glucose urine present  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Haematocrit decreased  1  3/18 (16.67%)  4 0/17 (0.00%)  0
Haemoglobin decreased  1  3/18 (16.67%)  5 0/17 (0.00%)  0
International normalised ratio increased  1  3/18 (16.67%)  3 1/17 (5.88%)  1
Lymphocyte count decreased  1  7/18 (38.89%)  13 5/17 (29.41%)  22
Lymphocyte count increased  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Monocyte count decreased  1  3/18 (16.67%)  3 0/17 (0.00%)  0
Monocyte count increased  1  4/18 (22.22%)  5 0/17 (0.00%)  0
Neutrophil count decreased  1  7/18 (38.89%)  24 4/17 (23.53%)  12
Neutrophil count increased  1  5/18 (27.78%)  5 0/17 (0.00%)  0
Platelet count decreased  1  8/18 (44.44%)  13 5/17 (29.41%)  15
Platelet count increased  1  3/18 (16.67%)  3 0/17 (0.00%)  0
Protein urine present  1  1/18 (5.56%)  1 2/17 (11.76%)  2
Prothrombin time prolonged  1  1/18 (5.56%)  1 1/17 (5.88%)  1
Red blood cell count decreased  1  2/18 (11.11%)  4 0/17 (0.00%)  0
Urine leukocyte esterase  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Weight decreased  1  0/18 (0.00%)  0 4/17 (23.53%)  4
Weight increased  1  0/18 (0.00%)  0 2/17 (11.76%)  2
White blood cell count decreased  1  10/18 (55.56%)  23 7/17 (41.18%)  15
White blood cell count increased  1  2/18 (11.11%)  2 0/17 (0.00%)  0
Metabolism and nutrition disorders     
Decreased appetite  1  7/18 (38.89%)  7 7/17 (41.18%)  14
Dehydration  1  1/18 (5.56%)  1 3/17 (17.65%)  4
Hypercalcaemia  1  0/18 (0.00%)  0 4/17 (23.53%)  7
Hypercholesterolaemia  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Hyperglycaemia  1  2/18 (11.11%)  4 1/17 (5.88%)  1
Hypermagnesaemia  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Hypernatraemia  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Hyperuricaemia  1  0/18 (0.00%)  0 1/17 (5.88%)  3
Hypoalbuminaemia  1  4/18 (22.22%)  12 9/17 (52.94%)  12
Hypocalcaemia  1  3/18 (16.67%)  6 5/17 (29.41%)  8
Hypoglycaemia  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Hypokalaemia  1  8/18 (44.44%)  20 7/17 (41.18%)  20
Hypomagnesaemia  1  10/18 (55.56%)  30 12/17 (70.59%)  32
Hyponatraemia  1  4/18 (22.22%)  7 4/17 (23.53%)  6
Hypophosphataemia  1  2/18 (11.11%)  2 1/17 (5.88%)  1
Malnutrition  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Metabolic acidosis  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Vitamin d deficiency  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Musculoskeletal and connective tissue disorders     
Back pain  1  1/18 (5.56%)  1 3/17 (17.65%)  3
Bone pain  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Flank pain  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Joint range of motion decreased  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Muscle spasms  1  2/18 (11.11%)  2 0/17 (0.00%)  0
Muscular weakness  1  1/18 (5.56%)  1 1/17 (5.88%)  1
Musculoskeletal chest pain  1  1/18 (5.56%)  2 0/17 (0.00%)  0
Musculoskeletal stiffness  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Myalgia  1  0/18 (0.00%)  0 3/17 (17.65%)  5
Neck pain  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Pain in extremity  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Benign neoplasm  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Nervous system disorders     
Cognitive disorder  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Dizziness  1  1/18 (5.56%)  1 4/17 (23.53%)  5
Dysgeusia  1  2/18 (11.11%)  2 7/17 (41.18%)  10
Headache  1  4/18 (22.22%)  6 5/17 (29.41%)  7
Memory impairment  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Neuropathy peripheral  1  3/18 (16.67%)  3 2/17 (11.76%)  2
Paraesthesia  1  1/18 (5.56%)  1 1/17 (5.88%)  1
Presyncope  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Sinus headache  1  0/18 (0.00%)  0 2/17 (11.76%)  2
Tremor  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Psychiatric disorders     
Anxiety  1  2/18 (11.11%)  2 3/17 (17.65%)  3
Depression  1  3/18 (16.67%)  4 2/17 (11.76%)  2
Insomnia  1  0/18 (0.00%)  0 2/17 (11.76%)  2
Mental status changes  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Restlessness  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Renal and urinary disorders     
Dysuria  1  0/18 (0.00%)  0 2/17 (11.76%)  2
Haematuria  1  1/18 (5.56%)  1 2/17 (11.76%)  2
Micturition urgency  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Nocturia  1  2/18 (11.11%)  2 0/17 (0.00%)  0
Pollakiuria  1  0/18 (0.00%)  0 3/17 (17.65%)  3
Proteinuria  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Renal failure  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Urinary incontinence  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Urinary tract pain  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Respiratory, thoracic and mediastinal disorders     
Atelectasis  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Cough  1  4/18 (22.22%)  4 4/17 (23.53%)  4
Dyspnoea  1  5/18 (27.78%)  5 3/17 (17.65%)  4
Dyspnoea exertional  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Epistaxis  1  1/18 (5.56%)  1 1/17 (5.88%)  1
Hiccups  1  0/18 (0.00%)  0 1/17 (5.88%)  2
Hypoxia  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Nasal congestion  1  0/18 (0.00%)  0 4/17 (23.53%)  7
Nasal dryness  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Oropharyngeal pain  1  0/18 (0.00%)  0 3/17 (17.65%)  3
Pleural effusion  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Productive cough  1  1/18 (5.56%)  2 1/17 (5.88%)  2
Rhinorrhoea  1  1/18 (5.56%)  1 4/17 (23.53%)  4
Sinus congestion  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Upper-airway cough syndrome  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Wheezing  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Skin and subcutaneous tissue disorders     
Alopecia  1  1/18 (5.56%)  1 2/17 (11.76%)  2
Dermatitis  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Dermatitis acneiform  1  4/18 (22.22%)  5 8/17 (47.06%)  8
Dry skin  1  3/18 (16.67%)  3 3/17 (17.65%)  3
Erythema  1  1/18 (5.56%)  1 2/17 (11.76%)  2
Hirsutism  1  1/11 (9.09%)  1 0/10 (0.00%)  0
Hyperhidrosis  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Ingrowing nail  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Night sweats  1  1/18 (5.56%)  1 1/17 (5.88%)  1
Onychomadesis  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Palmar-plantar erythrodysaesthesia syndrome  1  5/18 (27.78%)  5 2/17 (11.76%)  2
Pruritus  1  1/18 (5.56%)  3 2/17 (11.76%)  3
Rash  1  5/18 (27.78%)  7 5/17 (29.41%)  8
Rash macular  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Rash maculo-papular  1  7/18 (38.89%)  10 0/17 (0.00%)  0
Rash papular  1  0/18 (0.00%)  0 1/17 (5.88%)  2
Rash pruritic  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Skin fissures  1  0/18 (0.00%)  0 2/17 (11.76%)  3
Skin hyperpigmentation  1  0/18 (0.00%)  0 2/17 (11.76%)  4
Skin irritation  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Skin lesion  1  2/18 (11.11%)  2 0/17 (0.00%)  0
Skin reaction  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Swelling face  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Vascular disorders     
Deep vein thrombosis  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Flushing  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Hot flush  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Hypertension  1  2/18 (11.11%)  2 1/17 (5.88%)  1
Hypotension  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Orthostatic hypotension  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01606748    
Other Study ID Numbers: 14473
CP11-1115 ( Other Identifier: ImClone Systems )
I4X-IE-JFCJ ( Other Identifier: Eli Lilly and Company )
First Submitted: May 24, 2012
First Posted: May 28, 2012
Results First Submitted: December 21, 2015
Results First Posted: August 26, 2016
Last Update Posted: September 30, 2019