Study Of Anti-IGF-IR CP-751,871 In Patients With Solid Tumors

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00474760

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

21.7

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a phase 1 study of anti-IGF-IR CP-751,871 in patients with solid tumors currently enrolling patients 9 years old and older with Ewing's sarcoma family of tumors (Ewing's, PNET and Askin's).

Condition or Disease	Intervention/Treatment	Phase
Sarcoma, Ewing's	Drug: CP-751,871	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

65 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase 1, Open Label, Multiple Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of CP 751,871 In Patients With Advanced Solid Tumors

Study Start Date :

Aug 1, 2005

Actual Primary Completion Date :

Jan 1, 2011

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: CP-751,871 Currently dosing at 20 mg/kg, IV on day 1 of each 28 day cycle until progression or unacceptable toxicity

Arm

Intervention/Treatment

Experimental: 1

Drug: CP-751,871

Currently dosing at 20 mg/kg, IV on day 1 of each 28 day cycle until progression or unacceptable toxicity

Outcome Measures

Primary Outcome Measures

Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Baseline up to 150 days after the last administration of study drug]
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.

Secondary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) in Cycle 1 [Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose]
Maximum Observed Plasma Concentration (Cmax) in Cycle 4 [Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose]
Time to Reach Maximum Observed Plasma Concentration (Tmax) in Cycle 1 [Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose]
Time to Reach Maximum Observed Plasma Concentration (Tmax) in Cycle 4 [Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose]
Plasma Decay Half-Life (t1/2) in Cycle 1 [Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose]
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Plasma Decay Half-Life (t1/2) in Cycle 4 [Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose]
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time to Reach Last Quantifiable Concentration (Tlast) in Cycle 1 [Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose]
Time to Reach Last Quantifiable Concentration (Tlast) in Cycle 4 [Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose]
Systemic Clearance (CL) in Cycle 1 [Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose]
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Systemic Clearance (CL) in Cycle 4 [Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose]
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Concentration at End of Infusion (Cendinf) in Cycle 1 [Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose]
Concentration at End of Infusion (Cendinf) in Cycle 4 [Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose]
Volume of Distribution (Vz) in Cycle 1 [Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose]
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.
Volume of Distribution (Vz) in Cycle 4 [Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose]
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.
Volume of Distribution at Steady State (Vss) in Cycle 1 [Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose]
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.
Volume of Distribution at Steady State (Vss) in Cycle 4 [Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose]
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.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) in Cycle 1 [Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose]
Area under the plasma concentration time-curve from zero to the last measured concentration
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) in Cycle 4 [Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose]
Area under the plasma concentration time-curve from zero to the last measured concentration
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] in Cycle 1 [Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose]
Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0 - ∞).
Area Under the Plasma Concentration-time Profile From Time 0 to 504 Hours (21 Days) (AUC504) in Cycle 1 [Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose]
Area Under the Plasma Concentration-time Profile From Time 0 to 504 Hours (21 Days) (AUC504) in Cycle 4 [Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose]
Area Under the Plasma Concentration-time Profile From Time 0 to 672 Hours (28 Days) (AUC672) in Cycle 1 [Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose]
Area Under the Plasma Concentration-time Profile From Time 0 to 672 Hours (28 Days) (AUC672) in Cycle 4 [Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose]
Human Anti-human Antibodies (HAHA) Levels [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)]
HAHA were indicators of immunogenicity to figitumumab.
Number of Circulating Tumor Cells (CTCs) [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]
Quantification of CTCs using an automated microscope system
Number of Insulin-like Growth Factor 1 Receptor (IGF-1R) Positive CTCs [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]
Quantification of IGF-IR positive CTCs using an automated microscope system

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of Ewing's sarcoma family tumors

Exclusion Criteria:

Concurrent treatment with any other anti tumor agents

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Ann Arbor	Michigan	United States	48109-0848
2	Pfizer Investigational Site	Rochester	Minnesota	United States	55905
3	Pfizer Investigational Site	Sutton	Surrey	United Kingdom	SM2 5PT

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT00474760

Other Study ID Numbers:

A4021010

First Posted:

May 17, 2007

Last Update Posted:

Dec 17, 2013

Last Verified:

Oct 1, 2013

Additional relevant MeSH terms:

Sarcoma, Ewing

Neuroectodermal Tumors, Primitive, Peripheral

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail

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
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

Baseline Characteristics

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
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 Participants	3	3	3	3	13	29	11	65
Age, Customized (participants) [Number]
Less than (<) 70 years	3 100%	3 100%	3 100%	3 100%	13 100%	28 96.6%	11 100%	64 98.5%
Equal to or greater than (>=) 70 years	0 0%	0 0%	0 0%	0 0%	0 0%	1 3.4%	0 0%	1 1.5%
Sex: Female, Male (Count of Participants)
Female	1 33.3%	2 66.7%	1 33.3%	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%	12 92.3%	16 55.2%	8 72.7%	44 67.7%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
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

Outcome Measure Data

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
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.
Measure Participants	3	3	3	3	13	29	11
AEs	3 100%	3 100%	3 100%	3 100%	13 100%	29 100%	11 100%
SAEs	2 66.7%	1 33.3%	3 100%	1 33.3%	5 38.5%	17 58.6%	5 45.5%

2. Secondary Outcome

Title	Maximum Observed Plasma Concentration (Cmax) in Cycle 1
Description
Time Frame	Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose

Outcome Measure Data

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
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.
Measure Participants	3	3	3	3	34	9
Mean (Standard Deviation) [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
Description
Time Frame	Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose

Outcome Measure Data

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
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.
Measure Participants	16	6
Mean (Standard Deviation) [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
Description
Time Frame	Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose

Outcome Measure Data

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
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.
Measure Participants	3	3	3	3	34	9
Mean (Standard Deviation) [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
Description
Time Frame	Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose

Outcome Measure Data

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
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.
Measure Participants	16	6
Mean (Standard Deviation) [hours]	7.541 (16.343)	4.840 (9.436)

6. Secondary Outcome

Title	Plasma Decay Half-Life (t1/2) in Cycle 1
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

Outcome Measure Data

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
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.
Measure Participants	2	1	3	1	8	2
Mean (Standard Deviation) [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
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

Outcome Measure Data

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
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.
Measure Participants	5	3
Mean (Standard Deviation) [hours]	386.0 (172.16)	479.7 (163.59)

8. Secondary Outcome

Title	Time to Reach Last Quantifiable Concentration (Tlast) in Cycle 1
Description
Time Frame	Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose

Outcome Measure Data

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
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.
Measure Participants	3	3	3	3	34	9
Mean (Standard Deviation) [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
Description
Time Frame	Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose

Outcome Measure Data

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
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.
Measure Participants	16	6
Mean (Standard Deviation) [hours]	418.7 (227.37)	743.7 (100.81)

10. Secondary Outcome

Title	Systemic Clearance (CL) in Cycle 1
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

Outcome Measure Data

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
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.
Measure Participants	2	1	3	1	7	2
Mean (Standard Deviation) [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
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

Outcome Measure Data

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
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.
Measure Participants	9	6
Mean (Standard Deviation) [mL/day/kg]	2.576 (0.484)	2.612 (1.112)

12. Secondary Outcome

Title	Concentration at End of Infusion (Cendinf) in Cycle 1
Description
Time Frame	Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose

Outcome Measure Data

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
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.
Measure Participants	3	3	3	3	33	9
Mean (Standard Deviation) [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
Description
Time Frame	Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose

Outcome Measure Data

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
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.
Measure Participants	16	6
Mean (Standard Deviation) [mg/L]	685.0 (167.15)	650.3 (170.80)

14. Secondary Outcome

Title	Volume of Distribution (Vz) in Cycle 1
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

Outcome Measure Data

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
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.
Measure Participants	2	1	3	1	7	2
Mean (Standard Deviation) [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
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

Outcome Measure Data

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
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.
Measure Participants	5	3
Mean (Standard Deviation) [mL/kg]	61.98 (20.741)	89.17 (47.461)

16. Secondary Outcome

Title	Volume of Distribution at Steady State (Vss) in Cycle 1
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

Outcome Measure Data

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
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.
Measure Participants	2	1	3	1	7	2
Mean (Standard Deviation) [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
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

Outcome Measure Data

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
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.
Measure Participants	5	3
Mean (Standard Deviation) [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
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

Outcome Measure Data

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
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.
Measure Participants	3	2	3	3	31	9
Mean (Standard Deviation) [milligramhour/liter (mghr/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
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

Outcome Measure Data

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
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.
Measure Participants	16	6
Mean (Standard Deviation) [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
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

Outcome Measure Data

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
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.
Measure Participants	2	1	3	1	7	2
Mean (Standard Deviation) [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
Description
Time Frame	Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose

Outcome Measure Data

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
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.
Measure Participants	3	2	3	3	31
Mean (Standard Deviation) [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
Description
Time Frame	Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose

Outcome Measure Data

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
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.
Measure Participants	9
Mean (Standard Deviation) [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
Description
Time Frame	Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose

Outcome Measure Data

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
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.
Measure Participants	9
Mean (Standard Deviation) [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
Description
Time Frame	Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose

Outcome Measure Data

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
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.
Measure Participants	6
Mean (Standard Deviation) [mg*hr/L]	207200 (72334)

25. Secondary Outcome

Title	Human Anti-human Antibodies (HAHA) Levels
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)

Outcome Measure Data

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
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).
Measure Participants	0

26. Secondary Outcome

Title	Number of Circulating Tumor Cells (CTCs)
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

Outcome Measure Data

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
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.
Measure Participants	0

27. Secondary Outcome

Title	Number of Insulin-like Growth Factor 1 Receptor (IGF-1R) Positive CTCs
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

Outcome Measure Data

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
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.
Measure Participants	0

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
Time Frame
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
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
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/3 (66.7%)		1/3 (33.3%)		3/3 (100%)		1/3 (33.3%)		5/13 (38.5%)		17/29 (58.6%)		5/11 (45.5%)
Blood and lymphatic system disorders
Anaemia	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/13 (7.7%)		0/29 (0%)		0/11 (0%)
Gastrointestinal disorders
Ascites	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		1/29 (3.4%)		0/11 (0%)
Ileus	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		1/29 (3.4%)		0/11 (0%)
Intestinal obstruction	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/13 (7.7%)		0/29 (0%)		0/11 (0%)
Nausea	0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		1/29 (3.4%)		0/11 (0%)
Small intestinal obstruction	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/13 (7.7%)		0/29 (0%)		0/11 (0%)
Vomiting	0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		1/29 (3.4%)		1/11 (9.1%)
General disorders
Disease progression	1/3 (33.3%)		1/3 (33.3%)		3/3 (100%)		1/3 (33.3%)		2/13 (15.4%)		8/29 (27.6%)		3/11 (27.3%)
Fatigue	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		1/29 (3.4%)		0/11 (0%)
Oedema peripheral	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		1/29 (3.4%)		0/11 (0%)
Pyrexia	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Infections and infestations
Gastroenteritis	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		1/29 (3.4%)		0/11 (0%)
Lower respiratory tract infection	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Lower respiratory tract infection viral	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Pneumonia	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		1/29 (3.4%)		0/11 (0%)
Staphylococcal infection	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/13 (7.7%)		0/29 (0%)		0/11 (0%)
Blood creatinine increased	1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		0/11 (0%)
Investigations
Alanine aminotransferase increased	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Aspartate aminotransferase increased	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Blood culture positive	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Blood uric acid increased	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		1/29 (3.4%)		0/11 (0%)
Gamma-glutamyltransferase increased	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Haemoglobin decreased	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		1/29 (3.4%)		0/11 (0%)
Musculoskeletal and connective tissue disorders
Back pain	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/13 (7.7%)		1/29 (3.4%)		0/11 (0%)
Bone pain	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		1/29 (3.4%)		0/11 (0%)
Musculoskeletal pain	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		1/29 (3.4%)		0/11 (0%)
Pain in extremity	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		1/29 (3.4%)		1/11 (9.1%)
Nervous system disorders
Headache	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Intracranial pressure increased	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Spinal cord compression	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		1/29 (3.4%)		0/11 (0%)
Renal and urinary disorders
Proteinuria	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		1/29 (3.4%)		0/11 (0%)
Renal failure acute	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		1/29 (3.4%)		0/11 (0%)
Renal pain	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		1/29 (3.4%)		0/11 (0%)
Reproductive system and breast disorders
Female genital tract fistula	0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		0/11 (0%)
Respiratory, thoracic and mediastinal disorders
Pleural effusion	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		1/29 (3.4%)		0/11 (0%)
Pneumomediastinum	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Vascular disorders
Superior vena caval occlusion	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		1/29 (3.4%)		0/11 (0%)
Thrombosis	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		1/29 (3.4%)		0/11 (0%)
Other (Not Including 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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/3 (100%)		3/3 (100%)		3/3 (100%)		3/3 (100%)		13/13 (100%)		29/29 (100%)		11/11 (100%)
Blood and lymphatic system disorders
Anaemia	1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		2/13 (15.4%)		3/29 (10.3%)		1/11 (9.1%)
Lymphopenia	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		2/13 (15.4%)		0/29 (0%)		0/11 (0%)
Cardiac disorders
Tachycardia	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		1/29 (3.4%)		2/11 (18.2%)
Ear and labyrinth disorders
Ear congestion	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Ear pain	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		2/11 (18.2%)
Tinnitus	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Endocrine disorders
Delayed puberty	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Goitre	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Hypothyroidism	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Eye disorders
Conjunctivitis	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		1/29 (3.4%)		2/11 (18.2%)
Dry eye	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/13 (7.7%)		0/29 (0%)		1/11 (9.1%)
Eye pain	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Eye pruritus	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		2/11 (18.2%)
Keratitis	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Miosis	0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		0/11 (0%)
Ocular hyperaemia	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		2/11 (18.2%)
Vision blurred	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/13 (0%)		1/29 (3.4%)		0/11 (0%)
Gastrointestinal disorders
Abdominal distension	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		3/29 (10.3%)		1/11 (9.1%)
Abdominal pain	0/3 (0%)		0/3 (0%)		1/3 (33.3%)		1/3 (33.3%)		0/13 (0%)		1/29 (3.4%)		2/11 (18.2%)
Abdominal pain upper	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		2/11 (18.2%)
Cheilitis	1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		0/11 (0%)
Constipation	1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		3/13 (23.1%)		9/29 (31%)		4/11 (36.4%)
Dental caries	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Diarrhoea	0/3 (0%)		2/3 (66.7%)		2/3 (66.7%)		1/3 (33.3%)		6/13 (46.2%)		5/29 (17.2%)		7/11 (63.6%)
Dry mouth	1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		3/13 (23.1%)		4/29 (13.8%)		0/11 (0%)
Dyspepsia	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/13 (0%)		0/29 (0%)		3/11 (27.3%)
Dysphagia	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Flatulence	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/13 (7.7%)		3/29 (10.3%)		0/11 (0%)
Gastrointestinal haemorrhage	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Gingival bleeding	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		1/29 (3.4%)		2/11 (18.2%)
Haematochezia	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Mouth haemorrhage	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Nausea	0/3 (0%)		2/3 (66.7%)		2/3 (66.7%)		0/3 (0%)		8/13 (61.5%)		13/29 (44.8%)		4/11 (36.4%)
Oesophageal pain	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Oral pain	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Rectal haemorrhage	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/13 (7.7%)		0/29 (0%)		0/11 (0%)
Sensitivity of teeth	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Stomatitis	1/3 (33.3%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		1/13 (7.7%)		3/29 (10.3%)		0/11 (0%)
Tooth disorder	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Toothache	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		1/13 (7.7%)		0/29 (0%)		2/11 (18.2%)
Vomiting	1/3 (33.3%)		0/3 (0%)		2/3 (66.7%)		1/3 (33.3%)		6/13 (46.2%)		6/29 (20.7%)		7/11 (63.6%)
General disorders
Catheter site pain	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Catheter site related reaction	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Chest pain	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		4/29 (13.8%)		1/11 (9.1%)
Chills	0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		1/13 (7.7%)		0/29 (0%)		0/11 (0%)
Crepitations	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Disease progression	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Fatigue	0/3 (0%)		1/3 (33.3%)		0/3 (0%)		3/3 (100%)		6/13 (46.2%)		12/29 (41.4%)		7/11 (63.6%)
Feeling abnormal	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Gait disturbance	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Influenza like illness	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/13 (7.7%)		3/29 (10.3%)		1/11 (9.1%)
Infusion related reaction	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Localised oedema	0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		1/29 (3.4%)		0/11 (0%)
Malaise	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Mass	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Mucosal inflammation	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/13 (7.7%)		0/29 (0%)		1/11 (9.1%)
Oedema peripheral	0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		3/29 (10.3%)		1/11 (9.1%)
Pain	1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		3/11 (27.3%)
Pyrexia	0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		2/13 (15.4%)		1/29 (3.4%)		4/11 (36.4%)
Hepatobiliary disorders
Hyperbilirubinaemia	1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		0/11 (0%)
Immune system disorders
Graft versus host disease	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Seasonal allergy	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		2/11 (18.2%)
Infections and infestations
Eye infection	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Gastroenteritis viral	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/13 (7.7%)		0/29 (0%)		0/11 (0%)
Infection	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Influenza	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Nail infection	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Nasopharyngitis	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/13 (0%)		0/29 (0%)		3/11 (27.3%)
Oral candidiasis	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		2/11 (18.2%)
Sinusitis	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		2/11 (18.2%)
Skin infection	0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/13 (0%)		2/29 (6.9%)		0/11 (0%)
Staphylococcal infection	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/13 (7.7%)		0/29 (0%)		0/11 (0%)
Subcutaneous abscess	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Tinea pedis	1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		0/11 (0%)
Tooth abscess	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/13 (7.7%)		0/29 (0%)		0/11 (0%)
Tooth infection	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Upper respiratory tract infection	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		2/13 (15.4%)		1/29 (3.4%)		0/11 (0%)
Urinary tract infection	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		2/13 (15.4%)		0/29 (0%)		1/11 (9.1%)
Vulvovaginal candidiasis	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Vulvovaginal mycotic infection	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Injury, poisoning and procedural complications
Arthropod bite	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Contusion	1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		1/29 (3.4%)		1/11 (9.1%)
Joint sprain	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Procedural pain	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Scratch	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Wound dehiscence	0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		0/11 (0%)
Investigations
Activated partial thromboplastin time abnormal	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/13 (7.7%)		0/29 (0%)		0/11 (0%)
Activated partial thromboplastin time prolonged	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/13 (7.7%)		2/29 (6.9%)		0/11 (0%)
Alanine aminotransferase increased	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		5/13 (38.5%)		6/29 (20.7%)		1/11 (9.1%)
Aspartate aminotransferase increased	0/3 (0%)		1/3 (33.3%)		2/3 (66.7%)		0/3 (0%)		7/13 (53.8%)		7/29 (24.1%)		1/11 (9.1%)
Bacterial test positive	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Blood alkaline phosphatase increased	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/13 (7.7%)		4/29 (13.8%)		0/11 (0%)
Blood creatinine increased	1/3 (33.3%)		0/3 (0%)		1/3 (33.3%)		1/3 (33.3%)		1/13 (7.7%)		4/29 (13.8%)		1/11 (9.1%)
Blood glucose increased	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/13 (7.7%)		0/29 (0%)		0/11 (0%)
Blood magnesium increased	1/3 (33.3%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		1/13 (7.7%)		0/29 (0%)		0/11 (0%)
Blood phosphorus decreased	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/13 (7.7%)		0/29 (0%)		0/11 (0%)
Blood potassium decreased	1/3 (33.3%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		1/29 (3.4%)		0/11 (0%)
Blood potassium increased	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Blood sodium decreased	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Blood urea increased	0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		1/13 (7.7%)		0/29 (0%)		1/11 (9.1%)
Blood uric acid increased	1/3 (33.3%)		1/3 (33.3%)		1/3 (33.3%)		1/3 (33.3%)		3/13 (23.1%)		5/29 (17.2%)		1/11 (9.1%)
Body temperature	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Fungal test positive	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Gamma-glutamyltransferase increased	0/3 (0%)		1/3 (33.3%)		2/3 (66.7%)		0/3 (0%)		5/13 (38.5%)		7/29 (24.1%)		1/11 (9.1%)
Haemoglobin decreased	0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		2/13 (15.4%)		3/29 (10.3%)		1/11 (9.1%)
International normalised ratio increased	1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		0/11 (0%)
Neutrophil count decreased	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/13 (7.7%)		1/29 (3.4%)		0/11 (0%)
Neutrophil count increased	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/13 (7.7%)		0/29 (0%)		0/11 (0%)
Platelet count decreased	0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		1/13 (7.7%)		1/29 (3.4%)		0/11 (0%)
Pulse abnormal	0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		0/11 (0%)
Urine leukocyte esterase positive	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Weight decreased	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		3/29 (10.3%)		2/11 (18.2%)
Weight increased	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
White blood cell count decreased	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		2/29 (6.9%)		0/11 (0%)
Metabolism and nutrition disorders
Decreased appetite	2/3 (66.7%)		1/3 (33.3%)		2/3 (66.7%)		2/3 (66.7%)		5/13 (38.5%)		14/29 (48.3%)		6/11 (54.5%)
Dehydration	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		1/29 (3.4%)		1/11 (9.1%)
Hypercalcaemia	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		2/29 (6.9%)		0/11 (0%)
Hyperglycaemia	2/3 (66.7%)		1/3 (33.3%)		0/3 (0%)		3/3 (100%)		5/13 (38.5%)		8/29 (27.6%)		2/11 (18.2%)
Hyperkalaemia	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/13 (7.7%)		2/29 (6.9%)		1/11 (9.1%)
Hyperlipidaemia	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Hypermagnesaemia	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		2/13 (15.4%)		6/29 (20.7%)		1/11 (9.1%)
Hyperuricaemia	1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/13 (7.7%)		1/29 (3.4%)		0/11 (0%)
Hypocalcaemia	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/13 (7.7%)		1/29 (3.4%)		0/11 (0%)
Hypoglycaemia	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		2/29 (6.9%)		2/11 (18.2%)
Hypokalaemia	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		2/13 (15.4%)		0/29 (0%)		0/11 (0%)
Hyponatraemia	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/13 (0%)		5/29 (17.2%)		1/11 (9.1%)
Hypophosphataemia	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Type 2 diabetes mellitus	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Vitamin D deficiency	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/13 (7.7%)		1/29 (3.4%)		5/11 (45.5%)
Back pain	0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		2/13 (15.4%)		7/29 (24.1%)		4/11 (36.4%)
Flank pain	0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		0/11 (0%)
Groin pain	1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		0/11 (0%)
Limb discomfort	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Muscle spasms	0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		3/13 (23.1%)		5/29 (17.2%)		6/11 (54.5%)
Muscular weakness	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		4/29 (13.8%)		1/11 (9.1%)
Musculoskeletal chest pain	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/13 (7.7%)		2/29 (6.9%)		1/11 (9.1%)
Musculoskeletal pain	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		2/13 (15.4%)		3/29 (10.3%)		3/11 (27.3%)
Musculoskeletal stiffness	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Myalgia	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		2/11 (18.2%)
Neck pain	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Osteonecrosis	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Pain in extremity	1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		6/29 (20.7%)		1/11 (9.1%)
Trismus	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Tumour pain	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/13 (7.7%)		0/29 (0%)		0/11 (0%)
Nervous system disorders
Dizziness	0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		2/13 (15.4%)		4/29 (13.8%)		1/11 (9.1%)
Dizziness postural	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Dysgeusia	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		2/13 (15.4%)		1/29 (3.4%)		2/11 (18.2%)
Headache	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		1/13 (7.7%)		7/29 (24.1%)		4/11 (36.4%)
Hyporeflexia	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Lethargy	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		1/29 (3.4%)		3/11 (27.3%)
Neuropathy peripheral	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/13 (7.7%)		0/29 (0%)		0/11 (0%)
Paraesthesia	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		2/13 (15.4%)		0/29 (0%)		1/11 (9.1%)
Paralysis	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Phantom pain	1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		0/11 (0%)
Sinus headache	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Psychiatric disorders
Adjustment disorder	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/13 (0%)		0/29 (0%)		0/11 (0%)
Anxiety	0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/13 (0%)		2/29 (6.9%)		1/11 (9.1%)
Depressed mood	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/13 (7.7%)		0/29 (0%)		1/11 (9.1%)
Depression	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		2/29 (6.9%)		1/11 (9.1%)
Insomnia	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/13 (7.7%)		0/29 (0%)		0/11 (0%)
Renal and urinary disorders
Azotaemia	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/13 (7.7%)		0/29 (0%)		0/11 (0%)
Dysuria	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/13 (7.7%)		1/29 (3.4%)		1/11 (9.1%)
Haematuria	1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/13 (7.7%)		1/29 (3.4%)		1/11 (9.1%)
Microalbuminuria	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Pollakiuria	0/3 (0%)		0/3 (0%)		0/3 (0%)		2/3 (66.7%)		0/13 (0%)		2/29 (6.9%)		0/11 (0%)
Proteinuria	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		3/29 (10.3%)		1/11 (9.1%)
Renal impairment	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/13 (7.7%)		0/29 (0%)		0/11 (0%)
Urinary incontinence	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/13 (0%)		0/29 (0%)		0/11 (0%)
Reproductive system and breast disorders
Erectile dysfunction	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/13 (7.7%)		0/29 (0%)		0/11 (0%)
Pelvic pain	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/13 (0%)		1/29 (3.4%)		0/11 (0%)
Scrotal pain	1/3 (33.3%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/13 (0%)		0/29 (0%)		0/11 (0%)
Respiratory, thoracic and mediastinal disorders
Asthma	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Cough	1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		2/13 (15.4%)		3/29 (10.3%)		5/11 (45.5%)
Dysphonia	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		2/11 (18.2%)
Dyspnoea	0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		3/13 (23.1%)		4/29 (13.8%)		5/11 (45.5%)
Epistaxis	1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/13 (7.7%)		1/29 (3.4%)		4/11 (36.4%)
Haemoptysis	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		2/29 (6.9%)		0/11 (0%)
Hypoxia	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Nasal congestion	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		2/11 (18.2%)
Nasal discomfort	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Oropharyngeal pain	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/13 (7.7%)		2/29 (6.9%)		3/11 (27.3%)
Pneumonitis	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Pneumothorax	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Rhinitis allergic	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		2/11 (18.2%)
Rhinorrhoea	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		1/29 (3.4%)		1/11 (9.1%)
Sinus congestion	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Wheezing	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		2/11 (18.2%)
Skin and subcutaneous tissue disorders
Alopecia	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		2/13 (15.4%)		3/29 (10.3%)		0/11 (0%)
Alopecia totalis	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Blister	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Blood blister	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Dermal cyst	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Dermatitis contact	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		2/29 (6.9%)		0/11 (0%)
Dry skin	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		2/13 (15.4%)		1/29 (3.4%)		2/11 (18.2%)
Eczema	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		2/11 (18.2%)
Erythema	0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		0/11 (0%)
Hyperhidrosis	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Nail disorder	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		2/13 (15.4%)		0/29 (0%)		1/11 (9.1%)
Onychoclasis	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Petechiae	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		2/29 (6.9%)		0/11 (0%)
Pruritus	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		2/11 (18.2%)
Rash	0/3 (0%)		0/3 (0%)		1/3 (33.3%)		2/3 (66.7%)		0/13 (0%)		2/29 (6.9%)		2/11 (18.2%)
Skin discolouration	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/13 (7.7%)		0/29 (0%)		0/11 (0%)
Skin irritation	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/13 (7.7%)		0/29 (0%)		0/11 (0%)
Subcutaneous nodule	0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		1/29 (3.4%)		0/11 (0%)
Urticaria	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Surgical and medical procedures
Tooth extraction	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Tooth repair	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		0/29 (0%)		1/11 (9.1%)
Vascular disorders
Flushing	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		1/29 (3.4%)		1/11 (9.1%)
Haematoma	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/13 (7.7%)		0/29 (0%)		0/11 (0%)
Hot flush	0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/13 (0%)		1/29 (3.4%)		0/11 (0%)
Hypertension	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		2/13 (15.4%)		4/29 (13.8%)		1/11 (9.1%)
Hypotension	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		1/29 (3.4%)		1/11 (9.1%)
Pallor	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)		3/29 (10.3%)		1/11 (9.1%)

Limitations/Caveats

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.

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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

Name/Title	Pfizer ClinicalTrials.gov Call Center
Organization	Pfizer, Inc.
Phone	1-800-718-1021
Email	ClinicalTrials.gov_Inquiries@pfizer.com

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT00474760

Other Study ID Numbers:

A4021010

First Posted:

May 17, 2007

Last Update Posted:

Dec 17, 2013

Last Verified:

Oct 1, 2013

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Study Details

Study Description

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Primary Outcome Measures

Secondary Outcome Measures

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Outcome Measure Data

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Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

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Outcome Measure Data

Outcome Measure Data

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Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

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Adverse Events

All Cause Mortality

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