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Trial record 1 of 1 for:    NCT00474760
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Study Of Anti-IGF-IR CP-751,871 In Patients With Solid Tumors

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ClinicalTrials.gov Identifier: NCT00474760
Recruitment Status : Completed
First Posted : May 17, 2007
Results First Posted : December 17, 2013
Last Update Posted : December 17, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Sarcoma, Ewing's
Intervention Drug: CP-751,871
Enrollment 65
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Figitumumab 3 mg/kg Figitumumab 6 mg/kg Figitumumab 10 mg/kg Figitumumab 20 mg/kg Figitumumab 20 mg/kg RP2D Figitumumab 20 mg/kg RP2D ACC+Sarcoma Figitumumab 20 mg/kg RP2D ESFT
Hide Arm/Group Description Figitumumab 3 milligram/kilogram (mg/kg) was supplied as a liquid solution administered as an intravenous (IV) infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort. Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort. Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort. Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort. Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for recommended Phase 2 dose [RP2D] extension cohort. Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D adrenocortical carcinoma [ACC] and sarcoma extension cohort. Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D Ewing’s sarcoma family of tumors [ESFT] extension cohort.
Period Title: Overall Study
Started 3 3 3 3 13 29 11
Completed 0 0 0 0 1 0 1
Not Completed 3 3 3 3 12 29 10
Reason Not Completed
Death             0             0             0             0             2             0             0
Adverse Event             0             0             0             0             1             7             0
Laboratory abnormality             0             0             0             0             0             1             0
Withdrawal by Subject             0             0             0             1             0             1             1
Other             0             1             0             0             1             0             0
Progressive disease             3             2             3             2             8             20             7
Terminated by sponsor             0             0             0             0             0             0             2
Arm/Group Title Figitumumab 3 mg/kg Figitumumab 6 mg/kg Figitumumab 10 mg/kg Figitumumab 20 mg/kg Figitumumab 20 mg/kg RP2D Figitumumab 20 mg/kg RP2D ACC+Sarcoma Figitumumab 20 mg/kg RP2D ESFT Total
Hide Arm/Group Description Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort. Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort. Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort. Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort. Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D extension cohort. Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D ACC and sarcoma extension cohort. Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort. Total of all reporting groups
Overall Number of Baseline Participants 3 3 3 3 13 29 11 65
Hide Baseline Analysis Population Description
All enrolled participants
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 3 participants 13 participants 29 participants 11 participants 65 participants
Less than (<) 70 years 3 3 3 3 13 28 11 64
Equal to or greater than (>=) 70 years 0 0 0 0 0 1 0 1
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 3 participants 13 participants 29 participants 11 participants 65 participants
Female
1
  33.3%
2
  66.7%
1
  33.3%
0
   0.0%
1
   7.7%
13
  44.8%
3
  27.3%
21
  32.3%
Male
2
  66.7%
1
  33.3%
2
  66.7%
3
 100.0%
12
  92.3%
16
  55.2%
8
  72.7%
44
  67.7%
1.Primary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 150 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Time Frame Baseline up to 150 days after the last administration of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who started treatment.
Arm/Group Title Figitumumab 3 mg/kg Figitumumab 6 mg/kg Figitumumab 10 mg/kg Figitumumab 20 mg/kg Figitumumab 20 mg/kg RP2D Figitumumab 20 mg/kg RP2D ACC+Sarcoma Figitumumab 20 mg/kg RP2D ESFT
Hide Arm/Group Description:
Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D extension cohort.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D ACC and sarcoma extension cohort.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
Overall Number of Participants Analyzed 3 3 3 3 13 29 11
Measure Type: Number
Unit of Measure: participants
AEs 3 3 3 3 13 29 11
SAEs 2 1 3 1 5 17 5
2.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) in Cycle 1
Hide Description [Not Specified]
Time Frame Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants treated who had at least 1 of the pharmacokinetic (PK) parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.
Arm/Group Title Figitumumab 3 mg/kg Figitumumab 6 mg/kg Figitumumab 10 mg/kg Figitumumab 20 mg/kg Figitumumab 20 mg/kg RP2D Every 3 Weeks Figitumumab 20 mg/kg RP2D ESFT
Hide Arm/Group Description:
Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
Overall Number of Participants Analyzed 3 3 3 3 34 9
Mean (Standard Deviation)
Unit of Measure: milligram/liter (mg/L)
57.77  (2.658) 134.7  (31.754) 211.0  (59.808) 463.0  (97.964) 457.5  (135.68) 392.0  (90.308)
3.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) in Cycle 4
Hide Description [Not Specified]
Time Frame Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.
Arm/Group Title Figitumumab 20 mg/kg RP2D Every 3 Weeks Figitumumab 20 mg/kg RP2D ESFT
Hide Arm/Group Description:
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
Overall Number of Participants Analyzed 16 6
Mean (Standard Deviation)
Unit of Measure: mg/L
697.2  (165.40) 650.8  (169.92)
4.Secondary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax) in Cycle 1
Hide Description [Not Specified]
Time Frame Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.
Arm/Group Title Figitumumab 3 mg/kg Figitumumab 6 mg/kg Figitumumab 10 mg/kg Figitumumab 20 mg/kg Figitumumab 20 mg/kg RP2D Every 3 Weeks Figitumumab 20 mg/kg RP2D ESFT
Hide Arm/Group Description:
Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
Overall Number of Participants Analyzed 3 3 3 3 34 9
Mean (Standard Deviation)
Unit of Measure: hours
8.361  (13.552) 1.147  (0.117) 1.043  (0.075) 0.678  (0.558) 9.394  (28.527) 3.441  (7.718)
5.Secondary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax) in Cycle 4
Hide Description [Not Specified]
Time Frame Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.
Arm/Group Title Figitumumab 20 mg/kg RP2D Every 3 Weeks Figitumumab 20 mg/kg RP2D ESFT
Hide Arm/Group Description:
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
Overall Number of Participants Analyzed 16 6
Mean (Standard Deviation)
Unit of Measure: hours
7.541  (16.343) 4.840  (9.436)
6.Secondary Outcome
Title Plasma Decay Half-Life (t1/2) in Cycle 1
Hide Description Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.
Arm/Group Title Figitumumab 3 mg/kg Figitumumab 6 mg/kg Figitumumab 10 mg/kg Figitumumab 20 mg/kg Figitumumab 20 mg/kg RP2D Every 3 Weeks Figitumumab 20 mg/kg RP2D ESFT
Hide Arm/Group Description:
Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
Overall Number of Participants Analyzed 2 1 3 1 8 2
Mean (Standard Deviation)
Unit of Measure: hours
203.0  (7.071) 226.0 252.3  (56.713) 227.0 259.6  (80.500) 319.0  (8.485)
7.Secondary Outcome
Title Plasma Decay Half-Life (t1/2) in Cycle 4
Hide Description Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.
Arm/Group Title Figitumumab 20 mg/kg RP2D Every 3 Weeks Figitumumab 20 mg/kg RP2D ESFT
Hide Arm/Group Description:
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
Overall Number of Participants Analyzed 5 3
Mean (Standard Deviation)
Unit of Measure: hours
386.0  (172.16) 479.7  (163.59)
8.Secondary Outcome
Title Time to Reach Last Quantifiable Concentration (Tlast) in Cycle 1
Hide Description [Not Specified]
Time Frame Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.
Arm/Group Title Figitumumab 3 mg/kg Figitumumab 6 mg/kg Figitumumab 10 mg/kg Figitumumab 20 mg/kg Figitumumab 20 mg/kg RP2D Every 3 Weeks Figitumumab 20 mg/kg RP2D ESFT
Hide Arm/Group Description:
Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
Overall Number of Participants Analyzed 3 3 3 3 34 9
Mean (Standard Deviation)
Unit of Measure: hours
501.0  (4.583) 443.0  (96.995) 523.7  (41.041) 498.3  (1.155) 509.5  (100.13) 666.7  (3.082)
9.Secondary Outcome
Title Time to Reach Last Quantifiable Concentration (Tlast) in Cycle 4
Hide Description [Not Specified]
Time Frame Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.
Arm/Group Title Figitumumab 20 mg/kg RP2D Every 3 Weeks Figitumumab 20 mg/kg RP2D ESFT
Hide Arm/Group Description:
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
Overall Number of Participants Analyzed 16 6
Mean (Standard Deviation)
Unit of Measure: hours
418.7  (227.37) 743.7  (100.81)
10.Secondary Outcome
Title Systemic Clearance (CL) in Cycle 1
Hide Description CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Time Frame Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.
Arm/Group Title Figitumumab 3 mg/kg Figitumumab 6 mg/kg Figitumumab 10 mg/kg Figitumumab 20 mg/kg Figitumumab 20 mg/kg RP2D Every 3 Weeks Figitumumab 20 mg/kg RP2D ESFT
Hide Arm/Group Description:
Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
Overall Number of Participants Analyzed 2 1 3 1 7 2
Mean (Standard Deviation)
Unit of Measure: milliliter/day/kilogram (mL/day/kg)
6.435  (2.199) 3.600 4.807  (2.059) 4.990 3.846  (1.101) 3.155  (0.559)
11.Secondary Outcome
Title Systemic Clearance (CL) in Cycle 4
Hide Description CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Time Frame Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.
Arm/Group Title Figitumumab 20 mg/kg RP2D Every 3 Weeks Figitumumab 20 mg/kg RP2D ESFT
Hide Arm/Group Description:
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
Overall Number of Participants Analyzed 9 6
Mean (Standard Deviation)
Unit of Measure: mL/day/kg
2.576  (0.484) 2.612  (1.112)
12.Secondary Outcome
Title Concentration at End of Infusion (Cendinf) in Cycle 1
Hide Description [Not Specified]
Time Frame Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.
Arm/Group Title Figitumumab 3 mg/kg Figitumumab 6 mg/kg Figitumumab 10 mg/kg Figitumumab 20 mg/kg Figitumumab 20 mg/kg RP2D Every 3 Weeks Figitumumab 20 mg/kg RP2D ESFT
Hide Arm/Group Description:
Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
Overall Number of Participants Analyzed 3 3 3 3 33 9
Mean (Standard Deviation)
Unit of Measure: mg/L
57.50  (3.081) 134.7  (31.754) 211.0  (59.808) 463.0  (97.964) 434.3  (94.278) 386.3  (96.496)
13.Secondary Outcome
Title Concentration at End of Infusion (Cendinf) in Cycle 4
Hide Description [Not Specified]
Time Frame Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.
Arm/Group Title Figitumumab 20 mg/kg RP2D Every 3 Weeks Figitumumab 20 mg/kg RP2D ESFT
Hide Arm/Group Description:
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
Overall Number of Participants Analyzed 16 6
Mean (Standard Deviation)
Unit of Measure: mg/L
685.0  (167.15) 650.3  (170.80)
14.Secondary Outcome
Title Volume of Distribution (Vz) in Cycle 1
Hide Description Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
Time Frame Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.
Arm/Group Title Figitumumab 3 mg/kg Figitumumab 6 mg/kg Figitumumab 10 mg/kg Figitumumab 20 mg/kg Figitumumab 20 mg/kg RP2D Every 3 Weeks Figitumumab 20 mg/kg RP2D ESFT
Hide Arm/Group Description:
Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
Overall Number of Participants Analyzed 2 1 3 1 7 2
Mean (Standard Deviation)
Unit of Measure: milliliter/kilogram (mL/kg)
78.00  (24.183) 49.00 70.47  (25.733) 68.10 59.34  (14.360) 60.35  (9.122)
15.Secondary Outcome
Title Volume of Distribution (Vz) in Cycle 4
Hide Description Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
Time Frame Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.
Arm/Group Title Figitumumab 20 mg/kg RP2D Every 3 Weeks Figitumumab 20 mg/kg RP2D ESFT
Hide Arm/Group Description:
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
Overall Number of Participants Analyzed 5 3
Mean (Standard Deviation)
Unit of Measure: mL/kg
61.98  (20.741) 89.17  (47.461)
16.Secondary Outcome
Title Volume of Distribution at Steady State (Vss) in Cycle 1
Hide Description Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the Vz at steady-state.
Time Frame Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.
Arm/Group Title Figitumumab 3 mg/kg Figitumumab 6 mg/kg Figitumumab 10 mg/kg Figitumumab 20 mg/kg Figitumumab 20 mg/kg RP2D Every 3 Weeks Figitumumab 20 mg/kg RP2D ESFT
Hide Arm/Group Description:
Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
Overall Number of Participants Analyzed 2 1 3 1 7 2
Mean (Standard Deviation)
Unit of Measure: mL/kg
75.05  (20.011) 47.90 68.80  (23.477) 66.90 59.27  (14.765) 61.65  (6.435)
17.Secondary Outcome
Title Volume of Distribution at Steady State (Vss) in Cycle 4
Hide Description Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the Vz at steady-state.
Time Frame Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.
Arm/Group Title Figitumumab 20 mg/kg RP2D Every 3 Weeks Figitumumab 20 mg/kg RP2D ESFT
Hide Arm/Group Description:
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
Overall Number of Participants Analyzed 5 3
Mean (Standard Deviation)
Unit of Measure: mL/kg
60.84  (19.694) 86.07  (42.133)
18.Secondary Outcome
Title Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) in Cycle 1
Hide Description Area under the plasma concentration time-curve from zero to the last measured concentration
Time Frame Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.
Arm/Group Title Figitumumab 3 mg/kg Figitumumab 6 mg/kg Figitumumab 10 mg/kg Figitumumab 20 mg/kg Figitumumab 20 mg/kg RP2D Every 3 Weeks Figitumumab 20 mg/kg RP2D ESFT
Hide Arm/Group Description:
Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
Overall Number of Participants Analyzed 3 2 3 3 31 9
Mean (Standard Deviation)
Unit of Measure: milligram*hour/liter (mg*hr/L)
10900  (3005.0) 27500  (5656.9) 43900  (19630) 89430  (11904) 107900  (36398) 102700  (25300)
19.Secondary Outcome
Title Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) in Cycle 4
Hide Description Area under the plasma concentration time-curve from zero to the last measured concentration
Time Frame Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.
Arm/Group Title Figitumumab 20 mg/kg RP2D Every 3 Weeks Figitumumab 20 mg/kg RP2D ESFT
Hide Arm/Group Description:
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
Overall Number of Participants Analyzed 16 6
Mean (Standard Deviation)
Unit of Measure: mg*hr/L
166500  (77400) 214500  (67592)
20.Secondary Outcome
Title Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] in Cycle 1
Hide Description Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0 - ∞).
Time Frame Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.
Arm/Group Title Figitumumab 3 mg/kg Figitumumab 6 mg/kg Figitumumab 10 mg/kg Figitumumab 20 mg/kg Figitumumab 20 mg/kg RP2D Every 3 Weeks Figitumumab 20 mg/kg RP2D ESFT
Hide Arm/Group Description:
Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
Overall Number of Participants Analyzed 2 1 3 1 7 2
Mean (Standard Deviation)
Unit of Measure: mg*hr/L
11910  (4094.1) 40000 57770  (28167) 96300 136000  (47622) 154500  (27577)
21.Secondary Outcome
Title Area Under the Plasma Concentration-time Profile From Time 0 to 504 Hours (21 Days) (AUC504) in Cycle 1
Hide Description [Not Specified]
Time Frame Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants treated who had at least 1 of the PK parameters of primary interest in all cohorts except ESFT extension cohort. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: 20 mg/kg RP2D every 3 weeks.
Arm/Group Title Figitumumab 3 mg/kg Figitumumab 6 mg/kg Figitumumab 10 mg/kg Figitumumab 20 mg/kg Figitumumab 20 mg/kg RP2D Every 3 Weeks
Hide Arm/Group Description:
Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
Overall Number of Participants Analyzed 3 2 3 3 31
Mean (Standard Deviation)
Unit of Measure: mg*hr/L
10900  (3005.0) 27500  (5656.9) 43170  (20124) 89430  (11904) 104000  (32547)
22.Secondary Outcome
Title Area Under the Plasma Concentration-time Profile From Time 0 to 504 Hours (21 Days) (AUC504) in Cycle 4
Hide Description [Not Specified]
Time Frame Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants treated who had at least 1 of the PK parameters of primary interest in all cohorts except ESFT extension cohort. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: 20 mg/kg RP2D every 3 weeks.
Arm/Group Title Figitumumab 20 mg/kg RP2D Every 3 Weeks
Hide Arm/Group Description:
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: mg*hr/L
193100  (40001)
23.Secondary Outcome
Title Area Under the Plasma Concentration-time Profile From Time 0 to 672 Hours (28 Days) (AUC672) in Cycle 1
Hide Description [Not Specified]
Time Frame Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants treated who had at least 1 of the PK parameters of primary interest in RP2D ESFT extension cohort. N=number of participants evaluable for the outcome measure
Arm/Group Title Figitumumab 20 mg/kg RP2D ESFT
Hide Arm/Group Description:
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: mg*hr/L
102400  (25227)
24.Secondary Outcome
Title Area Under the Plasma Concentration-time Profile From Time 0 to 672 Hours (28 Days) (AUC672) in Cycle 4
Hide Description [Not Specified]
Time Frame Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants treated who had at least 1 of the PK parameters of primary interest in RP2D ESFT extension cohort. N=number of participants evaluable for the outcome measure
Arm/Group Title Figitumumab 20 mg/kg RP2D ESFT
Hide Arm/Group Description:
Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: mg*hr/L
207200  (72334)
25.Secondary Outcome
Title Human Anti-human Antibodies (HAHA) Levels
Hide Description HAHA were indicators of immunogenicity to figitumumab.
Time Frame 30 minutes predose in Cycles 1 up to 61, and last scheduled follow-up visit (up to 150 days from the last dose of study drug)
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, the presence of HAHA would only be evaluated for those samples with plasma figitumumab concentrations below the limit of quantification (BLQ). Since none of the postdose samples in the study had figitumumab concentrations BLQ, therefore no sample was analyzed for HAHA.
Arm/Group Title Figitumumab 3, 6, 10, 20 mg/kg
Hide Arm/Group Description:
Figitumumab 3, 6, 10, or 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration for dose escalation, RP2D extension, and RP2D ACC and sarcoma extension cohorts, 4 weeks in duration for RP2D ESFT extension cohort).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
26.Secondary Outcome
Title Number of Circulating Tumor Cells (CTCs)
Hide Description Quantification of CTCs using an automated microscope system
Time Frame 30 minutes predose in all cycles (up to 17); 1, 3, 7, and 14 days postdose in Cycle 1 for dose escalation and RP2D extension cohorts; and also 1 day postdose in Cycle 4 for RP2D extension cohort
Hide Outcome Measure Data
Hide Analysis Population Description
Pretreatment CTCs were detected in an insufficient number of participants to analyze for any treatment effect on this pharmacodynamic biomarker.
Arm/Group Title Figitumumab 3, 6, 10, 20 mg/kg
Hide Arm/Group Description:
Figitumumab 3, 6, 10, or 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation and RP2D extension cohorts.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
27.Secondary Outcome
Title Number of Insulin-like Growth Factor 1 Receptor (IGF-1R) Positive CTCs
Hide Description Quantification of IGF-IR positive CTCs using an automated microscope system
Time Frame 30 minutes predose in all cycles (up to 17); 1, 3, 7, and 14 days postdose in Cycle 1 for dose escalation and RP2D extension cohorts; and also 1 day postdose in Cycle 4 for RP2D extension cohort
Hide Outcome Measure Data
Hide Analysis Population Description
Pretreatment IGF-1R positive CTCs were detected in an insufficient number of participants to analyze for any treatment effect on this pharmacodynamic biomarker.
Arm/Group Title Figitumumab 3, 6, 10, 20 mg/kg
Hide Arm/Group Description:
Figitumumab 3, 6, 10, or 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation and RP2D extension cohorts.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Figitumumab 3 mg/kg Figitumumab 6 mg/kg Figitumumab 10 mg/kg Figitumumab 20 mg/kg Figitumumab 20 mg/kg RP2D Figitumumab 20 mg/kg RP2D ACC+Sarcoma Figitumumab 20 mg/kg RP2D ESFT
Hide Arm/Group Description Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort. Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort. Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort. Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort. Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D extension cohort. Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D ACC and sarcoma extension cohort. Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
All-Cause Mortality
Figitumumab 3 mg/kg Figitumumab 6 mg/kg Figitumumab 10 mg/kg Figitumumab 20 mg/kg Figitumumab 20 mg/kg RP2D Figitumumab 20 mg/kg RP2D ACC+Sarcoma Figitumumab 20 mg/kg RP2D ESFT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Figitumumab 3 mg/kg Figitumumab 6 mg/kg Figitumumab 10 mg/kg Figitumumab 20 mg/kg Figitumumab 20 mg/kg RP2D Figitumumab 20 mg/kg RP2D ACC+Sarcoma Figitumumab 20 mg/kg RP2D ESFT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/3 (66.67%)   1/3 (33.33%)   3/3 (100.00%)   1/3 (33.33%)   5/13 (38.46%)   17/29 (58.62%)   5/11 (45.45%) 
Blood and lymphatic system disorders               
Anaemia * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%)  0/29 (0.00%)  0/11 (0.00%) 
Gastrointestinal disorders               
Ascites * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  1/29 (3.45%)  0/11 (0.00%) 
Ileus * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  1/29 (3.45%)  0/11 (0.00%) 
Intestinal obstruction * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%)  0/29 (0.00%)  0/11 (0.00%) 
Nausea * 1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  1/29 (3.45%)  0/11 (0.00%) 
Small intestinal obstruction * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%)  0/29 (0.00%)  0/11 (0.00%) 
Vomiting * 1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  1/29 (3.45%)  1/11 (9.09%) 
General disorders               
Disease progression * 1  1/3 (33.33%)  1/3 (33.33%)  3/3 (100.00%)  1/3 (33.33%)  2/13 (15.38%)  8/29 (27.59%)  3/11 (27.27%) 
Fatigue * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  1/29 (3.45%)  0/11 (0.00%) 
Oedema peripheral * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  1/29 (3.45%)  0/11 (0.00%) 
Pyrexia * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Infections and infestations               
Gastroenteritis * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  1/29 (3.45%)  0/11 (0.00%) 
Lower respiratory tract infection * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Lower respiratory tract infection viral * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Pneumonia * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  1/29 (3.45%)  0/11 (0.00%) 
Staphylococcal infection * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%)  0/29 (0.00%)  0/11 (0.00%) 
Blood creatinine increased * 1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  0/11 (0.00%) 
Investigations               
Alanine aminotransferase increased * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Aspartate aminotransferase increased * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Blood culture positive * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Blood uric acid increased * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  1/29 (3.45%)  0/11 (0.00%) 
Gamma-glutamyltransferase increased * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Haemoglobin decreased * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  1/29 (3.45%)  0/11 (0.00%) 
Musculoskeletal and connective tissue disorders               
Back pain * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%)  1/29 (3.45%)  0/11 (0.00%) 
Bone pain * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  1/29 (3.45%)  0/11 (0.00%) 
Musculoskeletal pain * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  1/29 (3.45%)  0/11 (0.00%) 
Pain in extremity * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  1/29 (3.45%)  1/11 (9.09%) 
Nervous system disorders               
Headache * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Intracranial pressure increased * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Spinal cord compression * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  1/29 (3.45%)  0/11 (0.00%) 
Renal and urinary disorders               
Proteinuria * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  1/29 (3.45%)  0/11 (0.00%) 
Renal failure acute * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  1/29 (3.45%)  0/11 (0.00%) 
Renal pain * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  1/29 (3.45%)  0/11 (0.00%) 
Reproductive system and breast disorders               
Female genital tract fistula * 1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  0/11 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Pleural effusion * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  1/29 (3.45%)  0/11 (0.00%) 
Pneumomediastinum * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Vascular disorders               
Superior vena caval occlusion * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  1/29 (3.45%)  0/11 (0.00%) 
Thrombosis * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  1/29 (3.45%)  0/11 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 13.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Figitumumab 3 mg/kg Figitumumab 6 mg/kg Figitumumab 10 mg/kg Figitumumab 20 mg/kg Figitumumab 20 mg/kg RP2D Figitumumab 20 mg/kg RP2D ACC+Sarcoma Figitumumab 20 mg/kg RP2D ESFT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)   3/3 (100.00%)   3/3 (100.00%)   3/3 (100.00%)   13/13 (100.00%)   29/29 (100.00%)   11/11 (100.00%) 
Blood and lymphatic system disorders               
Anaemia * 1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/13 (15.38%)  3/29 (10.34%)  1/11 (9.09%) 
Lymphopenia * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/13 (15.38%)  0/29 (0.00%)  0/11 (0.00%) 
Cardiac disorders               
Tachycardia * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  1/29 (3.45%)  2/11 (18.18%) 
Ear and labyrinth disorders               
Ear congestion * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Ear pain * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  2/11 (18.18%) 
Tinnitus * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Endocrine disorders               
Delayed puberty * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Goitre * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Hypothyroidism * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Eye disorders               
Conjunctivitis * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  1/29 (3.45%)  2/11 (18.18%) 
Dry eye * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%)  0/29 (0.00%)  1/11 (9.09%) 
Eye pain * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Eye pruritus * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  2/11 (18.18%) 
Keratitis * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Miosis * 1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  0/11 (0.00%) 
Ocular hyperaemia * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  2/11 (18.18%) 
Vision blurred * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/13 (0.00%)  1/29 (3.45%)  0/11 (0.00%) 
Gastrointestinal disorders               
Abdominal distension * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  3/29 (10.34%)  1/11 (9.09%) 
Abdominal pain * 1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  0/13 (0.00%)  1/29 (3.45%)  2/11 (18.18%) 
Abdominal pain upper * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  2/11 (18.18%) 
Cheilitis * 1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  0/11 (0.00%) 
Constipation * 1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  3/13 (23.08%)  9/29 (31.03%)  4/11 (36.36%) 
Dental caries * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Diarrhoea * 1  0/3 (0.00%)  2/3 (66.67%)  2/3 (66.67%)  1/3 (33.33%)  6/13 (46.15%)  5/29 (17.24%)  7/11 (63.64%) 
Dry mouth * 1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  3/13 (23.08%)  4/29 (13.79%)  0/11 (0.00%) 
Dyspepsia * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/13 (0.00%)  0/29 (0.00%)  3/11 (27.27%) 
Dysphagia * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Flatulence * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%)  3/29 (10.34%)  0/11 (0.00%) 
Gastrointestinal haemorrhage * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Gingival bleeding * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  1/29 (3.45%)  2/11 (18.18%) 
Haematochezia * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Mouth haemorrhage * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Nausea * 1  0/3 (0.00%)  2/3 (66.67%)  2/3 (66.67%)  0/3 (0.00%)  8/13 (61.54%)  13/29 (44.83%)  4/11 (36.36%) 
Oesophageal pain * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Oral pain * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Rectal haemorrhage * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%)  0/29 (0.00%)  0/11 (0.00%) 
Sensitivity of teeth * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Stomatitis * 1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/13 (7.69%)  3/29 (10.34%)  0/11 (0.00%) 
Tooth disorder * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Toothache * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/13 (7.69%)  0/29 (0.00%)  2/11 (18.18%) 
Vomiting * 1  1/3 (33.33%)  0/3 (0.00%)  2/3 (66.67%)  1/3 (33.33%)  6/13 (46.15%)  6/29 (20.69%)  7/11 (63.64%) 
General disorders               
Catheter site pain * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Catheter site related reaction * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Chest pain * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  4/29 (13.79%)  1/11 (9.09%) 
Chills * 1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%)  0/29 (0.00%)  0/11 (0.00%) 
Crepitations * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Disease progression * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Fatigue * 1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  3/3 (100.00%)  6/13 (46.15%)  12/29 (41.38%)  7/11 (63.64%) 
Feeling abnormal * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Gait disturbance * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Influenza like illness * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%)  3/29 (10.34%)  1/11 (9.09%) 
Infusion related reaction * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Localised oedema * 1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  1/29 (3.45%)  0/11 (0.00%) 
Malaise * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Mass * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Mucosal inflammation * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%)  0/29 (0.00%)  1/11 (9.09%) 
Oedema peripheral * 1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  3/29 (10.34%)  1/11 (9.09%) 
Pain * 1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  3/11 (27.27%) 
Pyrexia * 1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  2/13 (15.38%)  1/29 (3.45%)  4/11 (36.36%) 
Hepatobiliary disorders               
Hyperbilirubinaemia * 1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  0/11 (0.00%) 
Immune system disorders               
Graft versus host disease * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Seasonal allergy * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  2/11 (18.18%) 
Infections and infestations               
Eye infection * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Gastroenteritis viral * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%)  0/29 (0.00%)  0/11 (0.00%) 
Infection * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Influenza * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Nail infection * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Nasopharyngitis * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/13 (0.00%)  0/29 (0.00%)  3/11 (27.27%) 
Oral candidiasis * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  2/11 (18.18%) 
Sinusitis * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  2/11 (18.18%) 
Skin infection * 1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/13 (0.00%)  2/29 (6.90%)  0/11 (0.00%) 
Staphylococcal infection * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%)  0/29 (0.00%)  0/11 (0.00%) 
Subcutaneous abscess * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Tinea pedis * 1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  0/11 (0.00%) 
Tooth abscess * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%)  0/29 (0.00%)  0/11 (0.00%) 
Tooth infection * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Upper respiratory tract infection * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/13 (15.38%)  1/29 (3.45%)  0/11 (0.00%) 
Urinary tract infection * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/13 (15.38%)  0/29 (0.00%)  1/11 (9.09%) 
Vulvovaginal candidiasis * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Vulvovaginal mycotic infection * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Injury, poisoning and procedural complications               
Arthropod bite * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Contusion * 1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  1/29 (3.45%)  1/11 (9.09%) 
Joint sprain * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Procedural pain * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Scratch * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Wound dehiscence * 1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  0/11 (0.00%) 
Investigations               
Activated partial thromboplastin time abnormal * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%)  0/29 (0.00%)  0/11 (0.00%) 
Activated partial thromboplastin time prolonged * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%)  2/29 (6.90%)  0/11 (0.00%) 
Alanine aminotransferase increased * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  5/13 (38.46%)  6/29 (20.69%)  1/11 (9.09%) 
Aspartate aminotransferase increased * 1  0/3 (0.00%)  1/3 (33.33%)  2/3 (66.67%)  0/3 (0.00%)  7/13 (53.85%)  7/29 (24.14%)  1/11 (9.09%) 
Bacterial test positive * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Blood alkaline phosphatase increased * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%)  4/29 (13.79%)  0/11 (0.00%) 
Blood creatinine increased * 1  1/3 (33.33%)  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  1/13 (7.69%)  4/29 (13.79%)  1/11 (9.09%) 
Blood glucose increased * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%)  0/29 (0.00%)  0/11 (0.00%) 
Blood magnesium increased * 1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/13 (7.69%)  0/29 (0.00%)  0/11 (0.00%) 
Blood phosphorus decreased * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%)  0/29 (0.00%)  0/11 (0.00%) 
Blood potassium decreased * 1  1/3 (33.33%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  1/29 (3.45%)  0/11 (0.00%) 
Blood potassium increased * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Blood sodium decreased * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Blood urea increased * 1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/13 (7.69%)  0/29 (0.00%)  1/11 (9.09%) 
Blood uric acid increased * 1  1/3 (33.33%)  1/3 (33.33%)  1/3 (33.33%)  1/3 (33.33%)  3/13 (23.08%)  5/29 (17.24%)  1/11 (9.09%) 
Body temperature * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Fungal test positive * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Gamma-glutamyltransferase increased * 1  0/3 (0.00%)  1/3 (33.33%)  2/3 (66.67%)  0/3 (0.00%)  5/13 (38.46%)  7/29 (24.14%)  1/11 (9.09%) 
Haemoglobin decreased * 1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  2/13 (15.38%)  3/29 (10.34%)  1/11 (9.09%) 
International normalised ratio increased * 1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  0/11 (0.00%) 
Neutrophil count decreased * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%)  1/29 (3.45%)  0/11 (0.00%) 
Neutrophil count increased * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%)  0/29 (0.00%)  0/11 (0.00%) 
Platelet count decreased * 1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/13 (7.69%)  1/29 (3.45%)  0/11 (0.00%) 
Pulse abnormal * 1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  0/11 (0.00%) 
Urine leukocyte esterase positive * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Weight decreased * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  3/29 (10.34%)  2/11 (18.18%) 
Weight increased * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
White blood cell count decreased * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  2/29 (6.90%)  0/11 (0.00%) 
Metabolism and nutrition disorders               
Decreased appetite * 1  2/3 (66.67%)  1/3 (33.33%)  2/3 (66.67%)  2/3 (66.67%)  5/13 (38.46%)  14/29 (48.28%)  6/11 (54.55%) 
Dehydration * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  1/29 (3.45%)  1/11 (9.09%) 
Hypercalcaemia * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  2/29 (6.90%)  0/11 (0.00%) 
Hyperglycaemia * 1  2/3 (66.67%)  1/3 (33.33%)  0/3 (0.00%)  3/3 (100.00%)  5/13 (38.46%)  8/29 (27.59%)  2/11 (18.18%) 
Hyperkalaemia * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%)  2/29 (6.90%)  1/11 (9.09%) 
Hyperlipidaemia * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Hypermagnesaemia * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  2/13 (15.38%)  6/29 (20.69%)  1/11 (9.09%) 
Hyperuricaemia * 1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%)  1/29 (3.45%)  0/11 (0.00%) 
Hypocalcaemia * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%)  1/29 (3.45%)  0/11 (0.00%) 
Hypoglycaemia * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  2/29 (6.90%)  2/11 (18.18%) 
Hypokalaemia * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/13 (15.38%)  0/29 (0.00%)  0/11 (0.00%) 
Hyponatraemia * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/13 (0.00%)  5/29 (17.24%)  1/11 (9.09%) 
Hypophosphataemia * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Type 2 diabetes mellitus * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Vitamin D deficiency * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Musculoskeletal and connective tissue disorders               
Arthralgia * 1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%)  1/29 (3.45%)  5/11 (45.45%) 
Back pain * 1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  2/13 (15.38%)  7/29 (24.14%)  4/11 (36.36%) 
Flank pain * 1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  0/11 (0.00%) 
Groin pain * 1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  0/11 (0.00%) 
Limb discomfort * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Muscle spasms * 1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  3/13 (23.08%)  5/29 (17.24%)  6/11 (54.55%) 
Muscular weakness * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  4/29 (13.79%)  1/11 (9.09%) 
Musculoskeletal chest pain * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%)  2/29 (6.90%)  1/11 (9.09%) 
Musculoskeletal pain * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/13 (15.38%)  3/29 (10.34%)  3/11 (27.27%) 
Musculoskeletal stiffness * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Myalgia * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  2/11 (18.18%) 
Neck pain * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Osteonecrosis * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Pain in extremity * 1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  6/29 (20.69%)  1/11 (9.09%) 
Trismus * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Skin papilloma * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Tumour pain * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%)  0/29 (0.00%)  0/11 (0.00%) 
Nervous system disorders               
Dizziness * 1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  2/13 (15.38%)  4/29 (13.79%)  1/11 (9.09%) 
Dizziness postural * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Dysgeusia * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/13 (15.38%)  1/29 (3.45%)  2/11 (18.18%) 
Headache * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/13 (7.69%)  7/29 (24.14%)  4/11 (36.36%) 
Hyporeflexia * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Lethargy * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  1/29 (3.45%)  3/11 (27.27%) 
Neuropathy peripheral * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%)  0/29 (0.00%)  0/11 (0.00%) 
Paraesthesia * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/13 (15.38%)  0/29 (0.00%)  1/11 (9.09%) 
Paralysis * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Phantom pain * 1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  0/11 (0.00%) 
Sinus headache * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Psychiatric disorders               
Adjustment disorder * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/13 (0.00%)  0/29 (0.00%)  0/11 (0.00%) 
Anxiety * 1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/13 (0.00%)  2/29 (6.90%)  1/11 (9.09%) 
Depressed mood * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%)  0/29 (0.00%)  1/11 (9.09%) 
Depression * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  2/29 (6.90%)  1/11 (9.09%) 
Insomnia * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%)  0/29 (0.00%)  0/11 (0.00%) 
Renal and urinary disorders               
Azotaemia * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%)  0/29 (0.00%)  0/11 (0.00%) 
Dysuria * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%)  1/29 (3.45%)  1/11 (9.09%) 
Haematuria * 1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%)  1/29 (3.45%)  1/11 (9.09%) 
Microalbuminuria * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Pollakiuria * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/3 (66.67%)  0/13 (0.00%)  2/29 (6.90%)  0/11 (0.00%) 
Proteinuria * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  3/29 (10.34%)  1/11 (9.09%) 
Renal impairment * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%)  0/29 (0.00%)  0/11 (0.00%) 
Urinary incontinence * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/13 (0.00%)  0/29 (0.00%)  0/11 (0.00%) 
Reproductive system and breast disorders               
Erectile dysfunction * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%)  0/29 (0.00%)  0/11 (0.00%) 
Pelvic pain * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/13 (0.00%)  1/29 (3.45%)  0/11 (0.00%) 
Scrotal pain * 1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/13 (0.00%)  0/29 (0.00%)  0/11 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Asthma * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Cough * 1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/13 (15.38%)  3/29 (10.34%)  5/11 (45.45%) 
Dysphonia * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  2/11 (18.18%) 
Dyspnoea * 1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  3/13 (23.08%)  4/29 (13.79%)  5/11 (45.45%) 
Epistaxis * 1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%)  1/29 (3.45%)  4/11 (36.36%) 
Haemoptysis * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  2/29 (6.90%)  0/11 (0.00%) 
Hypoxia * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Nasal congestion * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  2/11 (18.18%) 
Nasal discomfort * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Oropharyngeal pain * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%)  2/29 (6.90%)  3/11 (27.27%) 
Pneumonitis * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Pneumothorax * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Rhinitis allergic * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  2/11 (18.18%) 
Rhinorrhoea * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  1/29 (3.45%)  1/11 (9.09%) 
Sinus congestion * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Wheezing * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  2/11 (18.18%) 
Skin and subcutaneous tissue disorders               
Alopecia * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/13 (15.38%)  3/29 (10.34%)  0/11 (0.00%) 
Alopecia totalis * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Blister * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Blood blister * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Dermal cyst * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Dermatitis contact * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  2/29 (6.90%)  0/11 (0.00%) 
Dry skin * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/13 (15.38%)  1/29 (3.45%)  2/11 (18.18%) 
Eczema * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  2/11 (18.18%) 
Erythema * 1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  0/11 (0.00%) 
Hyperhidrosis * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Nail disorder * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/13 (15.38%)  0/29 (0.00%)  1/11 (9.09%) 
Onychoclasis * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Petechiae * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  2/29 (6.90%)  0/11 (0.00%) 
Pruritus * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  2/11 (18.18%) 
Rash * 1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  2/3 (66.67%)  0/13 (0.00%)  2/29 (6.90%)  2/11 (18.18%) 
Skin discolouration * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%)  0/29 (0.00%)  0/11 (0.00%) 
Skin irritation * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%)  0/29 (0.00%)  0/11 (0.00%) 
Subcutaneous nodule * 1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  1/29 (3.45%)  0/11 (0.00%) 
Urticaria * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Surgical and medical procedures               
Tooth extraction * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Tooth repair * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  0/29 (0.00%)  1/11 (9.09%) 
Vascular disorders               
Flushing * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  1/29 (3.45%)  1/11 (9.09%) 
Haematoma * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%)  0/29 (0.00%)  0/11 (0.00%) 
Hot flush * 1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/13 (0.00%)  1/29 (3.45%)  0/11 (0.00%) 
Hypertension * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/13 (15.38%)  4/29 (13.79%)  1/11 (9.09%) 
Hypotension * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  1/29 (3.45%)  1/11 (9.09%) 
Pallor * 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%)  3/29 (10.34%)  1/11 (9.09%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 13.1
The study was completed and 2 participants in figitumumab 20 mg/kg RP2D ESFT group were transitioned to compassionate figitumumab treatment as investigators judged they were receiving benefit from the protocol therapy.
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
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Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00474760    
Other Study ID Numbers: A4021010
First Submitted: May 16, 2007
First Posted: May 17, 2007
Results First Submitted: October 25, 2013
Results First Posted: December 17, 2013
Last Update Posted: December 17, 2013