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    Clinical Trial Results:
    PHASE 1 SAFETY AND TOLERABILITY STUDY OF FIGITUMUMAB COMBINED WITH PEGVISOMANT IN PATIENTS WITH ADVANCED SOLID TUMORS.

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2009-012769-74
    Trial protocol
    		 FI  
    Global end of trial date
    23 Oct 2012

    Results information
    Results version number
    		 v2(current)
    This version publication date
    23 Mar 2016
    First version publication date
    01 Aug 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • New data added to full data set
    • Correction of full data set
    reporting periods and duplicate AEs in their data

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    A4021040
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00976508
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 East 42nd Street, New York, United States, 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc, 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc, 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Jul 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Oct 2012
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the safety and tolerability of figitumumab plus pegvisomant in subjects with advanced solid tumors.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Nov 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Finland: 4
    Country: Number of subjects enrolled
    Germany: 5
    Country: Number of subjects enrolled
    United States: 11
    Country: Number of subjects enrolled
    Canada: 3
    Worldwide total number of subjects
    23
    EEA total number of subjects
    9
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    20
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study was started on 11-November-2009 and ended on 23 October 2012 in Finland, Germany, United States and Canada.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Figitumumab 20mg/kg + Pegvisomant 10 mg
    Arm description
    		 Figitumumab administered on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant administered subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days. 18 subjects were enrolled; 17 subjects were treated; 1 subject was not eligible. The completed subjects withdrew from last study treatment due to progressive disease.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Figitumumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year).

    Investigational medicinal product name
    Pegvisomant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year).

    Arm title
    		 Figitumumab 20mg/kg + Pegvisomant 20 mg
    Arm description
    		 Figitumumab administered on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant administered subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Figitumumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Figitumumab 20 mg/kg intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year).

    Investigational medicinal product name
    Pegvisomant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year).

    Number of subjects in period 1
    		Figitumumab 20mg/kg + Pegvisomant 10 mg Figitumumab 20mg/kg + Pegvisomant 20 mg
    Started
    17
    6
    Completed
    3
    0
    Not completed
    14
    6
         Termination by Sponsor
    -
    1
         Consent withdrawn by subject
    1
    -
         Death
    7
    1
         Subject Enrolled in Hospice
    1
    -
         Lost to follow-up
    1
    -
         Disease Progression
    4
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Figitumumab 20mg/kg + Pegvisomant 10 mg
    Reporting group description
    		 Figitumumab administered on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant administered subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days. 18 subjects were enrolled; 17 subjects were treated; 1 subject was not eligible. The completed subjects withdrew from last study treatment due to progressive disease.

    Reporting group title
    Figitumumab 20mg/kg + Pegvisomant 20 mg
    Reporting group description
    		 Figitumumab administered on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant administered subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.

    Reporting group values
    		 Figitumumab 20mg/kg + Pegvisomant 10 mg Figitumumab 20mg/kg + Pegvisomant 20 mg Total
    Number of subjects
    		 17 6 23
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 49.5 ( 17.4 ) 32.3 ( 9.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 8 5 13
        Male
    		 9 1 10

    End points

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    End points reporting groups
    Reporting group title
    Figitumumab 20mg/kg + Pegvisomant 10 mg
    Reporting group description
    		 Figitumumab administered on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant administered subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days. 18 subjects were enrolled; 17 subjects were treated; 1 subject was not eligible. The completed subjects withdrew from last study treatment due to progressive disease.

    Reporting group title
    Figitumumab 20mg/kg + Pegvisomant 20 mg
    Reporting group description
    		 Figitumumab administered on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant administered subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.

    Primary: Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)

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    End point title
    		 Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) [1]
    End point description
    Counts of subjects who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. AEs were graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 (Grade [Gr] 1 = Mild, Gr 2 = Moderate, Gr 3=Severe, Gr 4 = Life-threatening or disabling, Gr 5 = Death). Relatedness to [study drug] was assessed by the investigator (Yes/No). Subjects with multiple occurrences of an AE within a category were counted once within the category. Safety analysis set: all enrolled subjects who received at least 1 dose of either of the study medications.
    End point type
    Primary
    End point timeframe
    From Screening to the follow-up visit (90 days after last dose of figitimumab)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Figitumumab 20mg/kg + Pegvisomant 10 mg Figitumumab 20mg/kg + Pegvisomant 20 mg
    Number of subjects analysed
    17
    6
    Units: Subjects
        Number of Subjects with AEs
    17
    6
        Number of subjects with SAEs
    9
    4
        Number of subjects with Gr 3 or Gr 4 AEs
    12
    4
        Number of subjects with Gr 5 AEs
    7
    1
    No statistical analyses for this end point

    Primary: Number of Subjects With Dose Limiting Toxicities (DLT)

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    End point title
    		 Number of Subjects With Dose Limiting Toxicities (DLT) [2]
    End point description
    DLT was defined as any of the following events occurring during DLT period and considered related to study medication: Gr 4 neutropenia lasting more than or equal to (>=) 7 days, febrile neutropenia (Gr 3 or 4 neutropenia, fever >=38.5 degrees Celsius (°C), lasting over 24 hours), neutropenic infection (Gr >=3 neutropenia infection); Gr 3 or 4 thrombocytopenia associated with bleeding or Gr 4 thrombocytopenia >=7 days; Gr 3 or 4 lymphopenia accompanied by an opportunistic infection; other non-hematologic Gr 4 toxicities or symptomatic Gr 3 toxicities that require medical intervention and 14 days to resolve. Safety analysis set: all enrolled subjects who received at least 1 dose of either of the study medications. N= Number of subjects remained on treatment throughout the required DLT period and included as analyzed for DLT based on the defined DLT evaluability specifications were analyzed for this endpoint.
    End point type
    Primary
    End point timeframe
    From Cycle 2, Day 1 to Cycle 3, Day 8; from Cycle 1, Day 15 to end of Cycle 2
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Figitumumab 20mg/kg + Pegvisomant 10 mg Figitumumab 20mg/kg + Pegvisomant 20 mg
    Number of subjects analysed
    6
    6
    Units: Subjects
    1
    0
    No statistical analyses for this end point

    Secondary: Serum Circulating Insulin-like Growth Factor (IGF-1) Levels

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    End point title
    		 Serum Circulating Insulin-like Growth Factor (IGF-1) Levels
    End point description
    The effect of the combined therapy with figitumumab and pegvisomant on circulating concentrations of total IGF-1 was assessed. Biomarker analysis set: all enrolled subjects who had at least 1 baseline or on-study sample submitted. N=number of participants who were evaluable for IGF-1 Levels at prespecified time points. For this endpoint "99999" signifies not available (NA). For Figitumumab 20 mg/kg + Pegvisomant 10 mg reporting group in cycle 7 Standard deviation (SD) was not calculated as only 1 out of 17 subjects were evaluable ; In Figitumumab 20 mg/kg + Pegvisomant 10 mg reporting group for Cycle 08 to Cycle 27, Mean and SD were not calculated as the data was not analyzed since no subjects were evaluable; for Figitumumab 20mg/kg + Pegvisomant 20 mg reporting groupMean and SD were not calculated as only 1 out of 6 subjects were evaluable.
    End point type
    Secondary
    End point timeframe
    Days 1 and 15 of Cycle 1 (Baseline); Day 1 of subsequent cycles starting from Cycle 2 to Cycle 27; end of treatment (21 days after last dose of figitumumab); follow-up visit (90 days after last dose of figitumumab)
    End point values
    		 Figitumumab 20mg/kg + Pegvisomant 10 mg Figitumumab 20mg/kg + Pegvisomant 20 mg
    Number of subjects analysed
    17
    6
    Units: nanogram/milliliter (ng/mL)
    arithmetic mean (standard deviation)
        Baseline/Cycle 1 (n = 16, 6)
    150.18 ( 77.06 )
    189.17 ( 59.79 )
        Cycle 2 (n = 12, 6)
    725.72 ( 497.12 )
    498.5 ( 218.28 )
        Cycle 3 (n = 6, 5)
    474.53 ( 418.39 )
    247.4 ( 147.41 )
        Cycle 4 (n = 5, 3)
    542.09 ( 510.84 )
    124.67 ( 83.94 )
        Cycle 5 (n = 3, 4)
    990.4 ( 542.21 )
    248.25 ( 127.43 )
        Cycle 6 (n = 2, 2)
    1369.5 ( 161.93 )
    122.5 ( 137.89 )
        Cycle 7 (n = 1, 2)
    1594 ( 99999 )
    272.5 ( 105.36 )
        Cycle 8 (n = 0, 2)
    99999 ( 99999 )
    501 ( 94.75 )
        Cycle 9 (n = 0, 2)
    99999 ( 99999 )
    331 ( 229.1 )
        Cycle 10 (n = 0, 2)
    99999 ( 99999 )
    412.5 ( 185.97 )
        Cycle 11 (n = 0, 2)
    99999 ( 99999 )
    426.5 ( 119.5 )
        Cycle 12 (n = 0, 2)
    99999 ( 99999 )
    375.5 ( 350.02 )
        Cycle 13 (n = 0, 2)
    99999 ( 99999 )
    457.5 ( 36.06 )
        Cycle 14 (n = 0, 2)
    99999 ( 99999 )
    420 ( 45.25 )
        Cycle 15 (n = 0, 2)
    99999 ( 99999 )
    444.5 ( 47.38 )
        Cycle 16 (n = 0, 2)
    99999 ( 99999 )
    443.5 ( 23.33 )
        Cycle 17 (n = 0, 2)
    99999 ( 99999 )
    426 ( 4.24 )
        Cycle 18 (n = 0, 2)
    99999 ( 99999 )
    570.5 ( 487.2 )
        Cycle 19 (n = 0, 1)
    99999 ( 99999 )
    537 ( 99999 )
        Cycle 20 (n = 0, 2)
    99999 ( 99999 )
    458.5 ( 239.71 )
        Cycle 21 (n = 0, 2)
    99999 ( 99999 )
    437 ( 21.21 )
        Cycle 22 (n = 0, 1)
    99999 ( 99999 )
    401 ( 99999 )
        Cycle 23 (n = 0, 1)
    99999 ( 99999 )
    481 ( 99999 )
        Cycle 24 (n = 0, 1)
    99999 ( 99999 )
    361 ( 99999 )
        Cycle 25 (n = 0, 1)
    99999 ( 99999 )
    424 ( 99999 )
        Cycle 26 (n = 0, 1)
    99999 ( 99999 )
    366 ( 99999 )
        Cycle 27 (n = 0, 0)
    99999 ( 99999 )
    99999 ( 99999 )
        Follow-Up (n = 2, 1)
    791.5 ( 813.88 )
    1285 ( 99999 )
    No statistical analyses for this end point

    Secondary: Cycle 1: Maximum Observed Plasma Concentration (Cmax) of Figitumumab

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    End point title
    		 Cycle 1: Maximum Observed Plasma Concentration (Cmax) of Figitumumab
    End point description
    Pharmacokinetic (PK) samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.
    End point type
    Secondary
    End point timeframe
    Cycle 1: Day 1 (within 2 hours before figitumumab infusion), Day 2 (1 hour post figitumumab infusion), Day 8 and Day 15
    End point values
    		 Figitumumab 20mg/kg + Pegvisomant 10 mg Figitumumab 20mg/kg + Pegvisomant 20 mg
    Number of subjects analysed
    0 [3]
    0 [4]
    Units: ng\mL
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [3] - Study was terminated due to lack of operational feasibility and the halt of figitumumab development.
    [4] - Study was terminated due to lack of operational feasibility and the halt of figitumumab development.
    No statistical analyses for this end point

    Secondary: Maximum Observed Plasma Concentration (Cmax) of Figitumumab

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    End point title
    		 Maximum Observed Plasma Concentration (Cmax) of Figitumumab
    End point description
    PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.
    End point type
    Secondary
    End point timeframe
    Cycle 2: Day 1 (within 2 hours before and 1 hour after figitumumab infusion); Cycle 3 to Cycle 17: Day 1 (within 2 hours before figitumumab infusion); end of treatment; 90-day follow-up visit
    End point values
    		 Figitumumab 20mg/kg + Pegvisomant 10 mg Figitumumab 20mg/kg + Pegvisomant 20 mg
    Number of subjects analysed
    0 [5]
    0 [6]
    Units: ng/mL
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [5] - Study was terminated due to lack of operational feasibility and the halt of figitumumab development.
    [6] - Study was terminated due to lack of operational feasibility and the halt of figitumumab development.
    No statistical analyses for this end point

    Secondary: Cycle 1: Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab

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    End point title
    		 Cycle 1: Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab
    End point description
    PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.
    End point type
    Secondary
    End point timeframe
    Cycle 1: Day 1 (within 2 hours before figitumumab infusion), Day 2 (1 hour post figitumumab infusion), Day 8 and Day 15
    End point values
    		 Figitumumab 20mg/kg + Pegvisomant 10 mg Figitumumab 20mg/kg + Pegvisomant 20 mg
    Number of subjects analysed
    0 [7]
    0 [8]
    Units: ng/mL
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [7] - Study was terminated due to lack of operational feasibility and the halt of figitumumab development.
    [8] - Study was terminated due to lack of operational feasibility and the halt of figitumumab development.
    No statistical analyses for this end point

    Secondary: Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab

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    End point title
    		 Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab
    End point description
    Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab from Cycle 2 to the end of treatment. PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.
    End point type
    Secondary
    End point timeframe
    Cycle 2: Day 1 (within 2 hours before and 1 hour after figitumumab infusion); Cycle 3 to Cycle 17: Day 1 (within 2 hours before figitumumab infusion); end of treatment; 90-day follow-up visit.
    End point values
    		 Figitumumab 20mg/kg + Pegvisomant 10 mg Figitumumab 20mg/kg + Pegvisomant 20 mg
    Number of subjects analysed
    0 [9]
    0 [10]
    Units: ng/mL
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [9] - Study was terminated due to lack of operational feasibility and the halt of figitumumab development.
    [10] - Study was terminated due to lack of operational feasibility and the halt of figitumumab development.
    No statistical analyses for this end point

    Secondary: Cycle 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Figitumumab

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    End point title
    		 Cycle 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Figitumumab
    End point description
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) of figitumumab in cycle 1. PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.
    End point type
    Secondary
    End point timeframe
    Days 1, 2, 8 and 15 of Cycle 1; Day 1 of subsequent cycle starting from Cycle 2 (up to Cycle 17); end of treatment ( 21 days after last dose of figitumumab); follow-up visit (90 days after last dose of figitumumab).
    End point values
    		 Figitumumab 20mg/kg + Pegvisomant 10 mg Figitumumab 20mg/kg + Pegvisomant 20 mg
    Number of subjects analysed
    0 [11]
    0 [12]
    Units: nanogram*hours/milliliter (ng*hr/mL)
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [11] - Study was terminated due to lack of operational feasibility and the halt of figitumumab development.
    [12] - Study was terminated due to lack of operational feasibility and the halt of figitumumab development.
    No statistical analyses for this end point

    Secondary: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Figitumumab

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    End point title
    		 Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Figitumumab
    End point description
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) of figitumumab after Cycle 1. PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.
    End point type
    Secondary
    End point timeframe
    Cycle 2: Day 1 (within 2 hours before and 1 hour after figitumumab infusion); Cycle 3 to Cycle 17: Day 1 (within 2 hours before figitumumab infusion); end of treatment; 90-day follow-up visit.
    End point values
    		 Figitumumab 20mg/kg + Pegvisomant 10 mg Figitumumab 20mg/kg + Pegvisomant 20 mg
    Number of subjects analysed
    0 [13]
    0 [14]
    Units: ng*hr/mL
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [13] - Study was terminated due to lack of operational feasibility and the halt of figitumumab development.
    [14] - Study was terminated due to lack of operational feasibility and the halt of figitumumab development.
    No statistical analyses for this end point

    Secondary: Area Under the Trough Concentrations (AUCtrough)

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    End point title
    		 Area Under the Trough Concentrations (AUCtrough)
    End point description
    The trough concentration-time profile (AUCtrough) of pegvisomant was to be analyzed by noncompartmental methods. PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.
    End point type
    Secondary
    End point timeframe
    Cycle 1: Day 15 (within 2 hours before loading dose), Day 16 (within 2 hours pre-SC dose); Cycle 2: Days 1, 8 and 15 (within 2 hours pre-SC dose); Cycle 3 up to Cycle 17: Day 1 (within 2 hours pre-SC dose); end of treatment; 90-day follow-up visit.
    End point values
    		 Figitumumab 20mg/kg + Pegvisomant 10 mg Figitumumab 20mg/kg + Pegvisomant 20 mg
    Number of subjects analysed
    0 [15]
    0 [16]
    Units: ng*hr/mL
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [15] - Study was terminated due to lack of operational feasibility and the halt of figitumumab development.
    [16] - Study was terminated due to lack of operational feasibility and the halt of figitumumab development.
    No statistical analyses for this end point

    Secondary: Mean Change in Glucose Levels Between Fasting and Post Glucose Load

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    End point title
    		 Mean Change in Glucose Levels Between Fasting and Post Glucose Load
    End point description
    The effect of combining figitumumab with pegvisomant was analyzed to assess whether pegvisomant reverses figitumumab-induced glucose intolerance at various pegvisomant dose levels. The change in glucose load was assessed by Glucose Tolerance Testing (GTT) at baseline (fasting), during Cycle 1 following administration of figitumumab alone (post load), and near the end of Cycle 2 (post load) following combined therapy with figitumumab and pegvisomant. Glucose tolerance set: All enrolled subjects who started treatment and who had at least one baseline or on-study sample submitted. n=number of subjects with analyzable data for this outcome measure at specific time point.
    End point type
    Secondary
    End point timeframe
    Screening; Day 8 of Cycle 1; Day 15 of Cycle 2
    End point values
    		 Figitumumab 20mg/kg + Pegvisomant 10 mg Figitumumab 20mg/kg + Pegvisomant 20 mg
    Number of subjects analysed
    17
    6
    Units: milligram/deciliter (mg/dL)
    arithmetic mean (standard deviation)
        Screening (n = 17, 6)
    30.35 ( 34.02 )
    4.67 ( 17.6 )
        Cycle 1 Day 8 (n = 15, 5)
    37.68 ( 30.95 )
    15.4 ( 32.04 )
        Cycle 2 Day 15 (n = 4, 5)
    55.15 ( 49.35 )
    13.4 ( 28.35 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Reporting Positive Anti-Drug Antibodies (ADA) Response for Figitumumab

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    End point title
    		 Percentage of Subjects Reporting Positive Anti-Drug Antibodies (ADA) Response for Figitumumab
    End point description
    Percentage of subjects with positive total or neutralizing ADA for figitumumab. ADA samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.
    End point type
    Secondary
    End point timeframe
    Day 1 of Cycles 1 and 4; end of treatment (21 days after last dose of figitumumab); follow-up visit (90 days after last dose of figitumumab)
    End point values
    		 Figitumumab 20mg/kg + Pegvisomant 10 mg Figitumumab 20mg/kg + Pegvisomant 20 mg
    Number of subjects analysed
    0 [17]
    0 [18]
    Units: percentage of subjects
    Notes
    [17] - Study was terminated due to lack of operational feasibility and the halt of figitumumab development.
    [18] - Study was terminated due to lack of operational feasibility and the halt of figitumumab development.
    No statistical analyses for this end point

    Secondary: Number of subjects With Objective Response

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    End point title
    		 Number of subjects With Objective Response
    End point description
    Number of subjects with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST version 1.1. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response. Response-evaluable set: All subjects who started Cycle 1 with an adequate baseline tumor assessment and at least 1 follow up tumor assessment were analysed for this outcome measure.
    End point type
    Secondary
    End point timeframe
    From Screening, odd numbered cycles (pre- dose, Cycle 3, 5, 7 etc.) up to Cycle 27 or end of treatment visit (21 days after last dose of figitumumab)
    End point values
    		 Figitumumab 20mg/kg + Pegvisomant 10 mg Figitumumab 20mg/kg + Pegvisomant 20 mg
    Number of subjects analysed
    17
    6
    Units: subjects
    0
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AE and SAE were reported from first dose of the study treatment up to 90 -150 days after last dose of study treatment, death were reported from first dose of study treatment up to 28 days after last dose of study treatment
    Adverse event reporting additional description
    The same event may appear as both an AE and a 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.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Figitumumab 20 mg/kg + Pegvisomant 10 mg
    Reporting group description
    		 Figitumumab 20 mg/kg intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.

    Reporting group title
    Figitumumab 20 mg/kg + Pegvisomant 20 mg
    Reporting group description
    		 Figitumumab 20 mg/kg intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles (up to total duration of 27 cycles). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily up to total duration of 27 cycles. Each cycle was of 21 days.

    Serious adverse events
    		 Figitumumab 20 mg/kg + Pegvisomant 10 mg Figitumumab 20 mg/kg + Pegvisomant 20 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 17 (52.94%)
    4 / 6 (66.67%)
         number of deaths (all causes)
    2
    0
         number of deaths resulting from adverse events
    1
    0
    Investigations
    Blood uric acid increased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    C-reactive protein increased
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cauda equina syndrome
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical device complication
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disease progression
         subjects affected / exposed
    4 / 17 (23.53%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Pain
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Flank pain
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pelvic infection
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Figitumumab 20 mg/kg + Pegvisomant 10 mg Figitumumab 20 mg/kg + Pegvisomant 20 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 17 (100.00%)
    6 / 6 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Vaginal neoplasm
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Haematoma
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    2
    Pelvic venous thrombosis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Chest pain
         subjects affected / exposed
    2 / 17 (11.76%)
    2 / 6 (33.33%)
         occurrences all number
    4
    6
    Disease progression
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 6 (0.00%)
         occurrences all number
    4
    0
    Exercise tolerance decreased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Fatigue
         subjects affected / exposed
    13 / 17 (76.47%)
    4 / 6 (66.67%)
         occurrences all number
    18
    8
    General physical health deterioration
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Chills
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Injection site reaction
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Medical device pain
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Mucosal inflammation
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Necrosis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Oedema peripheral
         subjects affected / exposed
    2 / 17 (11.76%)
    1 / 6 (16.67%)
         occurrences all number
    2
    2
    Injection site induration
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Thirst
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Pyrexia
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    Peripheral swelling
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Pain
         subjects affected / exposed
    2 / 17 (11.76%)
    1 / 6 (16.67%)
         occurrences all number
    2
    2
    Immune system disorders
    Contrast media allergy
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Vaginal ulceration
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Atrophic vulvovaginitis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    4 / 17 (23.53%)
    1 / 6 (16.67%)
         occurrences all number
    7
    1
    Oropharyngeal pain
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Hiccups
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 6 (0.00%)
         occurrences all number
    3
    0
    Dyspnoea exertional
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Dyspnoea
         subjects affected / exposed
    3 / 17 (17.65%)
    1 / 6 (16.67%)
         occurrences all number
    4
    3
    Dysphonia
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 6 (16.67%)
         occurrences all number
    2
    2
    Pleural effusion
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Pulmonary congestion
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Pulmonary embolism
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Wheezing
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Confusional state
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Depression
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Insomnia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    C-reactive protein increased
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 6 (16.67%)
         occurrences all number
    1
    3
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Blood bilirubin increased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Blood creatinine increased
         subjects affected / exposed
    3 / 17 (17.65%)
    2 / 6 (33.33%)
         occurrences all number
    5
    2
    Blood uric acid increased
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 6 (0.00%)
         occurrences all number
    10
    0
    Blood albumin decreased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 6 (0.00%)
         occurrences all number
    3
    0
    Haemoglobin decreased
         subjects affected / exposed
    3 / 17 (17.65%)
    1 / 6 (16.67%)
         occurrences all number
    4
    3
    Insulin-like growth factor increased
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    0
    3
    International normalised ratio increased
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    Neutrophil count decreased
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Weight decreased
         subjects affected / exposed
    3 / 17 (17.65%)
    3 / 6 (50.00%)
         occurrences all number
    6
    5
    Platelet count decreased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Weight increased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    5
    Thermal burn
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Procedural pain
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Fall
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    5
    0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    2
    Nervous system disorders
    Dyskinesia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Dysgeusia
         subjects affected / exposed
    3 / 17 (17.65%)
    0 / 6 (0.00%)
         occurrences all number
    6
    0
    Facial nerve disorder
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Convulsion
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Dizziness
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 6 (0.00%)
         occurrences all number
    4
    0
    Hemiparesis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    2 / 17 (11.76%)
    2 / 6 (33.33%)
         occurrences all number
    7
    3
    Intracranial pressure increased
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Paraesthesia mucosal
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Paraesthesia
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Sensory disturbance
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Somnolence
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 6 (16.67%)
         occurrences all number
    2
    2
    Spinal cord compression
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    4
    0
    Anaemia
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 6 (33.33%)
         occurrences all number
    2
    2
    Thrombocytopenia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Neutropenia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Ear discomfort
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 6 (33.33%)
         occurrences all number
    2
    2
    Hearing impaired
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Sudden hearing loss
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Dry eye
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    Ocular hyperaemia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 6 (0.00%)
         occurrences all number
    3
    0
    Abdominal discomfort
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Abdominal distension
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 6 (16.67%)
         occurrences all number
    2
    1
    Dry mouth
         subjects affected / exposed
    3 / 17 (17.65%)
    0 / 6 (0.00%)
         occurrences all number
    4
    0
    Diarrhoea
         subjects affected / exposed
    7 / 17 (41.18%)
    4 / 6 (66.67%)
         occurrences all number
    7
    5
    Abdominal pain upper
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    0
    3
    Abdominal pain lower
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    5 / 17 (29.41%)
    2 / 6 (33.33%)
         occurrences all number
    6
    5
    Flatulence
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Gastric ulcer
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Eructation
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Erosive oesophagitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Dysphagia
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    0
    2
    Dyspepsia
         subjects affected / exposed
    2 / 17 (11.76%)
    3 / 6 (50.00%)
         occurrences all number
    2
    9
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Gastritis
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    Hiatus hernia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Impaired gastric emptying
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    9 / 17 (52.94%)
    2 / 6 (33.33%)
         occurrences all number
    13
    3
    Proctalgia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Rectal haemorrhage
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    2
    Vomiting
         subjects affected / exposed
    4 / 17 (23.53%)
    1 / 6 (16.67%)
         occurrences all number
    8
    1
    Stomatitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Alopecia
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Nail disorder
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Ecchymosis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Dry skin
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Pruritus
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Skin disorder
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Psoriasis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Pruritus generalised
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Urticaria
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Pollakiuria
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    Musculoskeletal and connective tissue disorders
    Bone swelling
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    4
    0
    Back pain
         subjects affected / exposed
    2 / 17 (11.76%)
    3 / 6 (50.00%)
         occurrences all number
    2
    3
    Joint swelling
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Flank pain
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Muscle spasms
         subjects affected / exposed
    5 / 17 (29.41%)
    3 / 6 (50.00%)
         occurrences all number
    6
    5
    Muscular weakness
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    2 / 17 (11.76%)
    1 / 6 (16.67%)
         occurrences all number
    6
    1
    Myalgia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Pain in extremity
         subjects affected / exposed
    2 / 17 (11.76%)
    1 / 6 (16.67%)
         occurrences all number
    2
    3
    Spinal pain
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    5
    0
    Infections and infestations
    Fungal infection
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Lung infection
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 6 (16.67%)
         occurrences all number
    2
    4
    Nasopharyngitis
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    Paronychia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    2
    Pelvic infection
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    2
    Urinary tract infection
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 17 (11.76%)
    1 / 6 (16.67%)
         occurrences all number
    3
    1
    Sinusitis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    2
    Wound infection
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Rhinitis
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    0
    7
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    5 / 17 (29.41%)
    0 / 6 (0.00%)
         occurrences all number
    7
    0
    Dehydration
         subjects affected / exposed
    4 / 17 (23.53%)
    0 / 6 (0.00%)
         occurrences all number
    4
    0
    Decreased appetite
         subjects affected / exposed
    9 / 17 (52.94%)
    2 / 6 (33.33%)
         occurrences all number
    11
    3
    Hyponatraemia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Hypocalcaemia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    2
    Hyperkalaemia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Hypermagnesaemia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Hypernatraemia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 May 2010
    1) Gamma-glutamyl transpeptidase (GGT) assessment was added to the Safety Laboratory tests, in addition fasting glucose assessment was modified from 4 hours to 8 hours.
    02 May 2011
    Safety Laboratory parameters assessment was modified to be performed and reviewed prior to beginning of each new cycle of therapy.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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