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    Clinical Trial Results:
    Dose Finding and Randomized, Multicenter, Placebo- Controlled, Phase 2 Study of Enzastaurin and Sunitinib versus Placebo and Sunitinib in Patients with Metastatic Renal Cell Carcinoma

    Summary
    EudraCT number
    		 2007-003847-66
    Trial protocol
    		 FR   AT   PL   IT   ES  
    Global end of trial date
    05 Sep 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Sep 2019
    First version publication date
    21 Sep 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    H6Q-MC-S061
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00709995
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 11531
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,
    Scientific contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,
    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
    05 Sep 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Sep 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    This study will compare the effects of Enzastaurin plus Sunitinib versus Sunitinib alone in metastatic Renal Cell Cancer.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Jun 2008
    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
    Austria: 2
    Country: Number of subjects enrolled
    Poland: 10
    Country: Number of subjects enrolled
    Italy: 3
    Country: Number of subjects enrolled
    France: 2
    Worldwide total number of subjects
    17
    EEA total number of subjects
    17
    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)
    12
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 No Text Available

    Pre-assignment
    Screening details
    		 Part 1 completers finished 3 or more cycles and included those with progressive disease. Part 2 was not performed and was not activated due to sponsor broad decision to not pursue enzastaurin in solid tumors.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Carer, Subject
    Blinding implementation details
    Part 2 was to be a randomized, double-blind treatment phase.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Modified Regimen A (Cohort 1)
    Arm description
    		 On cycle 1, day 1 a loading dose 125 milligram (mg) of Enzastaurin was administered by mouth orally, (BID) twice a day, followed by Enzastaurin 125 mg administered, twice a day, Days 2 through 42 of a 6-week cycle. Sunitinib 50 mg was administered orally, (QD) once daily, Days 1-28, then rest (no drug given) Days 29-42.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Enzastaurin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    On cycle 1, day 1 a loading dose 125 milligram (mg) of Enzastaurin was administered by mouth orally, (BID) twice a day, followed by Enzastaurin 125 mg administered, twice a day, Days 2 through 42 of a 6-week cycle.

    Investigational medicinal product name
    Sunitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Sunitinib 50 mg was administered orally, (QD) once daily, Days 1-28, then rest (no drug given) Days 29-42.

    Arm title
    		 Regimen A (Cohort 2)
    Arm description
    		 Enzastaurin was given on Day 1 of Cycle 1 as a loading dose of 1125 mg (3 tablets of 125 mg each, taken 3 times a day with at least 4 hours between doses), followed by daily total dose of 500 mg (2 tablets of 125 mg each, BID) continuously until disease progression, unacceptable toxicity, death, or discontinuation from the study for any other reason. Sunitinib 50 mg was administered orally, once daily, Days 1-28, then rest (no drug given) Days 29-42.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Enzastaurin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Enzastaurin was given on Day 1 of Cycle 1 as a loading dose of 1125 mg (3 tablets of 125 mg each, taken 3 times a day with at least 4 hours between doses), followed by daily total dose of 500 mg (2 tablets of 125 mg each, BID) continuously until disease progression, unacceptable toxicity, death, or discontinuation from the study for any other reason.

    Investigational medicinal product name
    Sunitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Sunitinib 50 mg was administered orally, once daily, Days 1-28, then rest (no drug given) Days 29-42.

    Number of subjects in period 1
    		Modified Regimen A (Cohort 1) Regimen A (Cohort 2)
    Started
    11
    6
    Progressive Disease
    6
    1
    Completed
    6
    1
    Not completed
    5
    5
         Consent withdrawn by subject
    1
    3
         Adverse event, non-fatal
    4
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Modified Regimen A (Cohort 1)
    Reporting group description
    		 On cycle 1, day 1 a loading dose 125 milligram (mg) of Enzastaurin was administered by mouth orally, (BID) twice a day, followed by Enzastaurin 125 mg administered, twice a day, Days 2 through 42 of a 6-week cycle. Sunitinib 50 mg was administered orally, (QD) once daily, Days 1-28, then rest (no drug given) Days 29-42.

    Reporting group title
    Regimen A (Cohort 2)
    Reporting group description
    		 Enzastaurin was given on Day 1 of Cycle 1 as a loading dose of 1125 mg (3 tablets of 125 mg each, taken 3 times a day with at least 4 hours between doses), followed by daily total dose of 500 mg (2 tablets of 125 mg each, BID) continuously until disease progression, unacceptable toxicity, death, or discontinuation from the study for any other reason. Sunitinib 50 mg was administered orally, once daily, Days 1-28, then rest (no drug given) Days 29-42.

    Reporting group values
    		 Modified Regimen A (Cohort 1) Regimen A (Cohort 2) Total
    Number of subjects
    		 11 6 17
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 60.1 ( 5.44 ) 58.5 ( 8.42 ) -
    Gender categorical
    Units: Subjects
        Female
    		 5 1 6
        Male
    		 6 5 11
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 0 0
        Not Hispanic or Latino
    		 11 6 17
        Unknown or Not Reported
    		 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 0 0
        White
    		 11 6 17
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 0 0
    Region of Enrollment
    Units: Subjects
        Austria
    		 1 1 2
        Poland
    		 6 4 10
        Italy
    		 3 0 3
        France
    		 1 1 2

    End points

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    End points reporting groups
    Reporting group title
    Modified Regimen A (Cohort 1)
    Reporting group description
    		 On cycle 1, day 1 a loading dose 125 milligram (mg) of Enzastaurin was administered by mouth orally, (BID) twice a day, followed by Enzastaurin 125 mg administered, twice a day, Days 2 through 42 of a 6-week cycle. Sunitinib 50 mg was administered orally, (QD) once daily, Days 1-28, then rest (no drug given) Days 29-42.

    Reporting group title
    Regimen A (Cohort 2)
    Reporting group description
    		 Enzastaurin was given on Day 1 of Cycle 1 as a loading dose of 1125 mg (3 tablets of 125 mg each, taken 3 times a day with at least 4 hours between doses), followed by daily total dose of 500 mg (2 tablets of 125 mg each, BID) continuously until disease progression, unacceptable toxicity, death, or discontinuation from the study for any other reason. Sunitinib 50 mg was administered orally, once daily, Days 1-28, then rest (no drug given) Days 29-42.

    Subject analysis set title
    Sunitinib + Placebo
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Sunitinib: 50 mg administered orally, once daily, Day 1-28, then rest Days 29-42. Placebo: Cycle 1 Day 1 loading dose 3 tablets on Day 1, then 2 tablets daily, Days 2-42.

    Subject analysis set title
    Enzastaurin + Sunitinib
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Enzastaurin: Cycle 1, Day 1 loading dose 375 mg administered orally, three times a day, followed by Part 1 dose twice a day on Days 2-42 of 6-week cycle. Sunitinib: 50 mg administered orally, once daily, on Days 1-28, then rest Days 29-42.

    Primary: Progression Free Survival (PFS) in Part 2

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    End point title
    		 Progression Free Survival (PFS) in Part 2 [1]
    End point description
    Progression-free survival (PFS) was defined as the number of months between the date of randomization and the date of first documented disease progression or the date of death due to any cause, whichever came first.
    End point type
    Primary
    End point timeframe
    Randomization to Measured Progressive Disease (PD) (Up to 24 Months)
    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: Zero participants were analyzed in the primary endpoint and therefore a statistical analysis was not done.
    End point values
    		 Sunitinib + Placebo Enzastaurin + Sunitinib
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: Number of Months
    Notes
    [2] - Zero participants data were collected. Part 2 was not activated due to sponsor broad decision.
    [3] - Zero participants data were collected. Part 2 was not activated due to sponsor broad decision.
    No statistical analyses for this end point

    Secondary: Overall Survival (OS) in Part 2

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    End point title
    		 Overall Survival (OS) in Part 2
    End point description
    OS time was defined as the number of months between the date of randomization and the date of death due to any cause.
    End point type
    Secondary
    End point timeframe
    Randomization to Death from Any Cause (Up to 24 Months)
    End point values
    		 Sunitinib + Placebo Enzastaurin + Sunitinib
    Number of subjects analysed
    0 [4]
    0 [5]
    Units: Number of Months
    Notes
    [4] - Zero participants data were collected. Part 2 was not activated due to sponsor broad decision.
    [5] - Zero participants data were collected. Part 2 was not activated due to sponsor broad decision.
    No statistical analyses for this end point

    Secondary: Time-To-Tumor Progression in Part 2

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    End point title
    		 Time-To-Tumor Progression in Part 2
    End point description
    Time to tumor progression (TTP) at initial treatment was defined as the number of months between date of randomization and the date of first documented disease progression or the date of death due to disease under study, whichever came first.
    End point type
    Secondary
    End point timeframe
    Randomization to the Date of Objective Progressive Disease or Date of Death due to Study Disease, whichever came first (Up to 24 Months)
    End point values
    		 Sunitinib + Placebo Enzastaurin + Sunitinib
    Number of subjects analysed
    0 [6]
    0 [7]
    Units: Number of Months
    Notes
    [6] - Zero participants data were collected. Part 2 was not activated due to sponsor broad decision.
    [7] - Zero participants data were collected. Part 2 was not activated due to sponsor broad decision.
    No statistical analyses for this end point

    Secondary: Number of Participants with Adverse Events (AEs) or Serious AEs (SAEs) in Part 1

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    End point title
    		 Number of Participants with Adverse Events (AEs) or Serious AEs (SAEs) in Part 1
    End point description
    Clinically significant events were defined as serious adverse events, regardless of causality. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module.
    End point type
    Secondary
    End point timeframe
    Randomization to Study Completion (Up to 6 Cycles)
    End point values
    		 Modified Regimen A (Cohort 1) Regimen A (Cohort 2)
    Number of subjects analysed
    11 [8]
    6 [9]
    Units: participants
        AEs
    11
    6
        SAEs
    3
    1
    Notes
    [8] - All randomized participants who received at least one dose of study drug.
    [9] - All randomized participants who received at least one dose of study drug.
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK): Area Under Concentration Time Curve during One Dosing Interval at Steady State (AUCτ,ss) of Enzastaurin + Metabolite (LSN326020) + Total Analytes in Part 1

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    End point title
    		 Pharmacokinetics (PK): Area Under Concentration Time Curve during One Dosing Interval at Steady State (AUCτ,ss) of Enzastaurin + Metabolite (LSN326020) + Total Analytes in Part 1
    End point description
    Pharmacokinetics (PK) was assessed in participants to determine the area under the concentration time curve during one dosing interval at steady state (AUCτ,ss) of Enzastaurin, LSN326020 and total Analytes. τ equals 12 hours for Enzastaurin, LSN326020 and total Analytes.
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 15: Predose, 2, 4, and 6 - 8 hours, Up to 12 Hours Post dose
    End point values
    		 Modified Regimen A (Cohort 1) Regimen A (Cohort 2)
    Number of subjects analysed
    11 [10]
    5 [11]
    Units: nanomole*hour/liter (nmol*hr/L)
    geometric mean (geometric coefficient of variation)
        Enzastaurin
    12000 ( 144 )
    22600 ( 91 )
        LSN326020
    8820 ( 76 )
    12200 ( 73 )
        Total Analytes
    21400 ( 101 )
    35200 ( 82 )
    Notes
    [10] - All randomized participants who received at least one dose of study drug had evaluable PK data.
    [11] - All randomized participants who received at least one dose of study drug had evaluable PK data.
    No statistical analyses for this end point

    Secondary: PK: Maximum Concentration at Steady State (Cmax,ss) of Enzastaurin + LSN326020 + Total Analytes in Part 1

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    End point title
    		 PK: Maximum Concentration at Steady State (Cmax,ss) of Enzastaurin + LSN326020 + Total Analytes in Part 1
    End point description
    PK was assessed in participants to determine the maximum concentration at steady state (Cmax, ss) of Enzastaurin + LSN326020 + total analytes.
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 15: Predose, 2, 4, and 6 - 8 hours, Up to 12 Hours Post dose
    End point values
    		 Modified Regimen A (Cohort 1) Regimen A (Cohort 2)
    Number of subjects analysed
    11 [12]
    5 [13]
    Units: nanomole/liter (nmol/L)
    geometric mean (geometric coefficient of variation)
        Enzastaurin
    1310 ( 109 )
    2650 ( 71 )
        LSN326020
    816 ( 72 )
    1140 ( 64 )
        Total Analytes
    2130 ( 88 )
    3740 ( 65 )
    Notes
    [12] - All randomized participants who received at least one dose of study drug had evaluable PK data.
    [13] - All randomized participants who received at least one dose of study drug had evaluable PK data.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Baseline to Study Completion (Up to 123 Months)
    Adverse event reporting additional description
    All participants who received at least one dose of study drug in Part 1.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    Modified Regimen A (Cohort 1)
    Reporting group description
    		 -

    Reporting group title
    Regimen A (Cohort 2)
    Reporting group description
    		 -

    Serious adverse events
    		 Modified Regimen A (Cohort 1) Regimen A (Cohort 2)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 11 (27.27%)
    1 / 6 (16.67%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    thrombosis
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    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
    general physical health deterioration
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    0 / 11 (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
    abdominal pain
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastrointestinal obstruction
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    dyspnoea
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hydrothorax
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pulmonary embolism
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Modified Regimen A (Cohort 1) Regimen A (Cohort 2)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 11 (100.00%)
    6 / 6 (100.00%)
    Vascular disorders
    hypertension
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    4 / 11 (36.36%)
    0 / 6 (0.00%)
         occurrences all number
    4
    0
    hypotension
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    3 / 11 (27.27%)
    1 / 6 (16.67%)
         occurrences all number
    5
    1
    chest pain
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    chills
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    face oedema
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 6 (16.67%)
         occurrences all number
    1
    5
    fatigue
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    5 / 11 (45.45%)
    3 / 6 (50.00%)
         occurrences all number
    5
    9
    general physical health deterioration
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    2 / 11 (18.18%)
    1 / 6 (16.67%)
         occurrences all number
    2
    2
    influenza like illness
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    malaise
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    mucosal inflammation
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    oedema
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    oedema peripheral
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    4 / 11 (36.36%)
    1 / 6 (16.67%)
         occurrences all number
    7
    1
    pyrexia
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    cough
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    dyspnoea
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    epistaxis
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    haemoptysis
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    hydrothorax
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    nasal congestion
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    pharyngolaryngeal pain
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    rhinorrhoea
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Psychiatric disorders
    depression
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    insomnia
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    3 / 11 (27.27%)
    0 / 6 (0.00%)
         occurrences all number
    3
    0
    Investigations
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 6 (16.67%)
         occurrences all number
    1
    13
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    60
    blood amylase increased
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    blood bilirubin decreased
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    blood cholesterol increased
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    blood creatinine increased
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    0 / 11 (0.00%)
    3 / 6 (50.00%)
         occurrences all number
    0
    22
    blood lactate dehydrogenase increased
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    blood sodium increased
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    blood triglycerides increased
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    31
    blood urea increased
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    c-reactive protein increased
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    vitamin b12 decreased
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    weight decreased
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    4 / 11 (36.36%)
    0 / 6 (0.00%)
         occurrences all number
    4
    0
    weight increased
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    skin laceration
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    2 / 11 (18.18%)
    1 / 6 (16.67%)
         occurrences all number
    2
    1
    wound
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    bradycardia
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    dysgeusia
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    4 / 11 (36.36%)
    0 / 6 (0.00%)
         occurrences all number
    4
    0
    headache
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    hypoaesthesia
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    paraesthesia
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    8 / 11 (72.73%)
    4 / 6 (66.67%)
         occurrences all number
    33
    10
    leukopenia
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    3 / 11 (27.27%)
    0 / 6 (0.00%)
         occurrences all number
    4
    0
    lymphopenia
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    neutropenia
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    5 / 11 (45.45%)
    1 / 6 (16.67%)
         occurrences all number
    7
    87
    thrombocytopenia
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    9 / 11 (81.82%)
    2 / 6 (33.33%)
         occurrences all number
    20
    32
    Ear and labyrinth disorders
    vertigo
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Eye disorders
    eyelid oedema
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    lacrimation increased
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 6 (0.00%)
         occurrences all number
    5
    0
    Gastrointestinal disorders
    abdominal discomfort
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    abdominal pain
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    2 / 11 (18.18%)
    4 / 6 (66.67%)
         occurrences all number
    2
    5
    abdominal pain upper
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    anal discomfort
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    anal inflammation
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    3 / 11 (27.27%)
    1 / 6 (16.67%)
         occurrences all number
    3
    1
    constipation
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    dental discomfort
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    diarrhoea
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    7 / 11 (63.64%)
    5 / 6 (83.33%)
         occurrences all number
    14
    5
    dry mouth
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    dyspepsia
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    3 / 11 (27.27%)
    0 / 6 (0.00%)
         occurrences all number
    3
    0
    dysphagia
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    flatulence
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    2
    gastrointestinal pain
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    gingivitis
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    haematochezia
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    haemorrhoids
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    0
    2
    mouth haemorrhage
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    nausea
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    4 / 11 (36.36%)
    2 / 6 (33.33%)
         occurrences all number
    7
    3
    oesophagitis
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    proctalgia
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    stomatitis
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    6 / 11 (54.55%)
    1 / 6 (16.67%)
         occurrences all number
    9
    4
    vomiting
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    3 / 11 (27.27%)
    4 / 6 (66.67%)
         occurrences all number
    3
    8
    Skin and subcutaneous tissue disorders
    alopecia
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    dry skin
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    hair colour changes
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    nail disorder
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    palmar-plantar erythrodysaesthesia syndrome
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 6 (0.00%)
         occurrences all number
    5
    0
    petechiae
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    rash papular
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    skin exfoliation
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    5 / 11 (45.45%)
    2 / 6 (33.33%)
         occurrences all number
    7
    3
    skin ulcer
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    urticaria localised
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    yellow skin
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    2 / 11 (18.18%)
    1 / 6 (16.67%)
         occurrences all number
    4
    1
    Renal and urinary disorders
    haematuria
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 6 (0.00%)
         occurrences all number
    3
    0
    Endocrine disorders
    hyperthyroidism
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    hypothyroidism
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    3 / 11 (27.27%)
    1 / 6 (16.67%)
         occurrences all number
    3
    1
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    bone pain
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    musculoskeletal chest pain
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    musculoskeletal pain
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    pain in extremity
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    2 / 11 (18.18%)
    1 / 6 (16.67%)
         occurrences all number
    3
    1
    Infections and infestations
    bronchitis
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    cystitis
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    herpes zoster
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    laryngitis
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    pharyngitis
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    tooth infection
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    upper respiratory tract infection
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    2 / 11 (18.18%)
    1 / 6 (16.67%)
         occurrences all number
    3
    1
    Metabolism and nutrition disorders
    anorexia
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    4 / 11 (36.36%)
    0 / 6 (0.00%)
         occurrences all number
    5
    0
    hypercalcaemia
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    hypercholesterolaemia
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 6 (16.67%)
         occurrences all number
    1
    8
    hyperkalaemia
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    3 / 11 (27.27%)
    2 / 6 (33.33%)
         occurrences all number
    7
    2
    hyperuricaemia
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    2 / 11 (18.18%)
    1 / 6 (16.67%)
         occurrences all number
    2
    1
    hypoalbuminaemia
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    hypocalcaemia
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 6 (16.67%)
         occurrences all number
    2
    1
    hypokalaemia
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 6 (0.00%)
         occurrences all number
    3
    0
    hypomagnesaemia
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    hyponatraemia
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    0
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Jan 2010
    The protocol has been amended to modify ECG monitoring in response to US FDA's recommendation on associated QTc prolongation for enzastaurin. Part 2 of the study, sponsor decided to not activate the randomized phase 2 portion of the study (Part 2). The study will end after all participants have discontinued from Part 1 of the study. Assessments in the participants on long-term study therapy, for those participants who continue enzastaurin treatment for extended durations, assessments for efficacy and safety will be performed at the investigator's discretion based on local practice standards.

    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.
    Part 1 completers finished 3 or more cycles and included those with progressive disease. Part 2 was not performed and was not activated due to sponsor broad decision to not pursue enzastaurin in solid tumors
    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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