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    Clinical Trial Results:
    A Phase II, Open-label, Randomized Study of GDC-0980 versus Everolimus in Patients with Metastatic Renal Cell Carcinoma Who Have Progressed on or following VEGF-Targeted Therapy

    Summary
    EudraCT number
    		 2011-000493-56
    Trial protocol
    		 ES   DE   GB  
    Global end of trial date
    23 Jun 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Jul 2016
    First version publication date
    08 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PIM4973g
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01442090
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Other Study Identifier : GO00885
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.com
    Scientific contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.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
    23 Jun 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jun 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of GDC-0980 versus everolimus as measured by progression-free survival (PFS) defined as the time from randomization to disease progression.
    Protection of trial subjects
    All study subjects were required to read and sign an Informed Consent form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Oct 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 10
    Country: Number of subjects enrolled
    United Kingdom: 28
    Country: Number of subjects enrolled
    France: 20
    Country: Number of subjects enrolled
    Germany: 10
    Country: Number of subjects enrolled
    United States: 17
    Worldwide total number of subjects
    85
    EEA total number of subjects
    68
    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)
    59
    From 65 to 84 years
    25
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 85 subjects were enrolled into the study from 5 countries.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GDC-0980
    Arm description
    		 Subjects with metastatic renal cell carcinoma (RCC) who have progressed on or after vascular endothelial growth factor (VEGF) targeted therapy received GDC0980 40 milligram (mg) orally, once daily up until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GDC-0980
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received GDC-0980 40 mg orally once daily.

    Arm title
    		 Everolimus
    Arm description
    		 Subjects with metastatic renal cell carcinoma (RCC) who have progressed on or after vascular endothelial growth factor (VEGF) targeted therapy received everolimus 10 mg orally, once daily up until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Everolimus
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received everolimus 10 mg orally once daily.

    Number of subjects in period 1
    		GDC-0980 Everolimus
    Started
    42
    43
    Completed
    0
    0
    Not completed
    42
    43
         Death
    28
    23
         Study terminated by sponsor
    1
    2
         Reason not specified
    12
    15
         Withdrawal by subject
    1
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GDC-0980
    Reporting group description
    		 Subjects with metastatic renal cell carcinoma (RCC) who have progressed on or after vascular endothelial growth factor (VEGF) targeted therapy received GDC0980 40 milligram (mg) orally, once daily up until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.

    Reporting group title
    Everolimus
    Reporting group description
    		 Subjects with metastatic renal cell carcinoma (RCC) who have progressed on or after vascular endothelial growth factor (VEGF) targeted therapy received everolimus 10 mg orally, once daily up until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.

    Reporting group values
    		 GDC-0980 Everolimus Total
    Number of subjects
    		 42 43 85
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 28 31 59
        From 65-84 years
    		 14 11 25
        85 years and over
    		 0 1 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 60.3 ± 8.1 60.5 ± 9.9 -
    Gender categorical
    Units: Subjects
        Female
    		 9 12 21
        Male
    		 33 31 64

    End points

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    End points reporting groups
    Reporting group title
    GDC-0980
    Reporting group description
    		 Subjects with metastatic renal cell carcinoma (RCC) who have progressed on or after vascular endothelial growth factor (VEGF) targeted therapy received GDC0980 40 milligram (mg) orally, once daily up until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.

    Reporting group title
    Everolimus
    Reporting group description
    		 Subjects with metastatic renal cell carcinoma (RCC) who have progressed on or after vascular endothelial growth factor (VEGF) targeted therapy received everolimus 10 mg orally, once daily up until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.

    Primary: Duration of Progression-Free Survival (PFS)

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    End point title
    		 Duration of Progression-Free Survival (PFS) [1]
    End point description
    PFS was defined as the time from randomization to disease progression, as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, or death from any cause. Progression was defined as a 20% increase in the sum of the longest diameter of target lesions, the appearance of new lesions and increase of at least 5 millimeters (mm) in the sum of diameters of target lesions. Kaplan-Meier was used to estimate the medians of each treatment arm. Analysis was performed on the safety evaluable population defined as all subjects who were treated with any amount of study drug.
    End point type
    Primary
    End point timeframe
    Baseline until disease progression, or death, which occurred first (up to approximately 23 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: Only descriptive data was planned to be reported.
    End point values
    		 GDC-0980 Everolimus
    Number of subjects analysed
    42
    43
    Units: months
        median (confidence interval 95%)
    3.7 (3.5 to 5.4)
    6.1 (3.7 to 9)
    No statistical analyses for this end point

    Secondary: Maximum Plasma Concentration (Cmax) of GDC-0980

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    End point title
    		 Maximum Plasma Concentration (Cmax) of GDC-0980 [2]
    End point description
    Pharmacokinetics (PK)-evaluable population was defined as all safety-evaluable subjects with any available PK data.
    End point type
    Secondary
    End point timeframe
    Week 1 Day 1, Week 3 Day 1, Week 9 Day 1
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No inter-group analysis was performed.
    End point values
    		 GDC-0980
    Number of subjects analysed
    41
    Units: nanogram per milliliter (ng/mL)
    geometric mean (standard deviation)
        Week 1 Day 1 (n=41)
    210 ± 116
        Week 3 Day 1 (n=33)
    267 ± 155
        Week 9 Day 1 (n=24)
    266 ± 130
    No statistical analyses for this end point

    Secondary: Cmax of Everolimus

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    End point title
    		 Cmax of Everolimus [3]
    End point description
    Week 1 Day 1 and Week 9 Day 1
    End point type
    Secondary
    End point timeframe
    PK-evaluable population was defined as all safety-evaluable subjects with any available PK data.
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No inter-group analysis was performed.
    End point values
    		 Everolimus
    Number of subjects analysed
    0 [4]
    Units: (ng/mL)
        geometric mean (standard deviation)
    ±
    Notes
    [4] - Due to sampling error, no PK analyses were reported.
    No statistical analyses for this end point

    Secondary: Minimum Plasma Concentration (Cmin) of GDC-0980

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    End point title
    		 Minimum Plasma Concentration (Cmin) of GDC-0980 [5]
    End point description
    PK-evaluable population was defined as all safety-evaluable subjects with any available PK data.
    End point type
    Secondary
    End point timeframe
    Week 1 Day 1, Week 3 Day 1, Week 9 Day 1
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No inter-group analysis was performed.
    End point values
    		 GDC-0980
    Number of subjects analysed
    41
    Units: ng/mL
    geometric mean (standard deviation)
        Week 1 Day 1 (n=41)
    55.1 ± 52.1
        Week 3 Day 1 (n=33)
    57.5 ± 94.1
        Week 9 Day 1 (n=24)
    51.6 ± 74.3
    No statistical analyses for this end point

    Secondary: Cmin of Everolimus

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    End point title
    		 Cmin of Everolimus [6]
    End point description
    PK-evaluable population was defined as all safety-evaluable subjects with any available PK data.
    End point type
    Secondary
    End point timeframe
    Week 1 Day 1, Week 9 Day 1
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No inter-group analysis was performed.
    End point values
    		 Everolimus
    Number of subjects analysed
    0 [7]
    Units: ng/mL
        geometric mean (standard deviation)
    ±
    Notes
    [7] - Due to sampling error, no PK analyses were reported.
    No statistical analyses for this end point

    Secondary: Number of Subjects With an Adverse Event (AE)

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    End point title
    		 Number of Subjects With an Adverse Event (AE)
    End point description
    An AE was defined as any unfavorable or unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product or other protocol-imposed intervention, regardless of attribution. Analysis was performed on the safety evaluable population defined as all subjects who were treated with any amount of study drug.
    End point type
    Secondary
    End point timeframe
    Up to 30 days after end of treatment (approximately 23 months)
    End point values
    		 GDC-0980 Everolimus
    Number of subjects analysed
    42
    43
    Units: Subjects
    42
    41
    No statistical analyses for this end point

    Secondary: Number of Subjects With Objective Tumor Response

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    End point title
    		 Number of Subjects With Objective Tumor Response
    End point description
    Best objective response was assessed by RECIST 1.1 and defined as the best response recorded from the start of treatment until disease progression. Complete response (CR) was defined as the disappearance of all target lesions. Partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions. Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions. Stable disease (SD) was defined as neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD. Analysis was performed on the safety evaluable population defined as all subjects who were treated with any amount of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline until disease progression or death, whichever occurred first (up to approximately 23 months)
    End point values
    		 GDC-0980 Everolimus
    Number of subjects analysed
    42
    43
    Units: Subjects
        CR
    1
    1
        PR
    3
    6
        PD
    8
    11
        SD
    27
    25
    No statistical analyses for this end point

    Secondary: Duration of Objective Tumor Response

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    End point title
    		 Duration of Objective Tumor Response
    End point description
    Duration of objective tumor response was defined as the time from first observation of an objective tumor response until first observation of disease progression as assessed by the investigator using RECIST 1.1. Analysis was performed on the safety evaluable population defined as all subjects who were treated with any amount of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline until disease progression or death, whichever occurred first (up to approximately 23 months)
    End point values
    		 GDC-0980 Everolimus
    Number of subjects analysed
    0 [8]
    0 [9]
    Units: months
        median (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [8] - Duration of response was not summarized due to limited number of responses.
    [9] - Duration of response was not summarized due to limited number of responses.
    No statistical analyses for this end point

    Secondary: Duration of Overall Survival (OS)

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    End point title
    		 Duration of Overall Survival (OS)
    End point description
    OS was defined as the time from treatment initiation until death from any cause. Analysis was performed on the safety evaluable population defined as all subjects who were treated with any amount of study drug. Here, '99999' represents that the confidence interval was not evaluable.
    End point type
    Secondary
    End point timeframe
    Baseline until death (up to approximately 45 months)
    End point values
    		 GDC-0980 Everolimus
    Number of subjects analysed
    42
    43
    Units: Months
        median (confidence interval 95%)
    16.5 (10.8 to 21.4)
    19.9 (12.4 to 99999)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From signing of the informed consent form up to 30 days after the last administration of study drug or until initiation of another anti-cancer therapy, whichever occurs first.
    Adverse event reporting additional description
    An AE was defined as any unfavorable or unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product or other protocol-imposed intervention, regardless of attribution.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    GDC-0980
    Reporting group description
    		 Subjects with metastatic renal cell carcinoma (RCC) who have progressed on or after vascular endothelial growth factor (VEGF) targeted therapy received GDC0980 40 milligram (mg) orally, once daily up until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.

    Reporting group title
    Everolimus
    Reporting group description
    		 Subjects with metastatic renal cell carcinoma (RCC) who have progressed on or after vascular endothelial growth factor (VEGF) targeted therapy received everolimus 10 mg orally, once daily up until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.

    Serious adverse events
    		 GDC-0980 Everolimus
    Total subjects affected by serious adverse events
         subjects affected / exposed
    28 / 42 (66.67%)
    10 / 43 (23.26%)
         number of deaths (all causes)
    28
    23
         number of deaths resulting from adverse events
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Renal cell carcinoma
         subjects affected / exposed
    2 / 42 (4.76%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mucosal inflammation
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea exertional
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Pleural effusion
         subjects affected / exposed
    2 / 42 (4.76%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femoral neck fracture
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Pericardial effusion
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Migraine
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal fissure
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal angiodysplasia
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Swollen tongue
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis exfoliative
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ichthyosis acquired
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash maculo-papular
         subjects affected / exposed
    2 / 42 (4.76%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Anaemia
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Muscular weakness
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteitis
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abscess
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eczema impetiginous
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonia
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 42 (4.76%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary sepsis
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia haemophilus
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypercalcaemia
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    4 / 42 (9.52%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    4 / 4
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 GDC-0980 Everolimus
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    42 / 42 (100.00%)
    41 / 43 (95.35%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 42 (7.14%)
    1 / 43 (2.33%)
         occurrences all number
    3
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    12 / 42 (28.57%)
    16 / 43 (37.21%)
         occurrences all number
    19
    32
    Mucosal inflammation
         subjects affected / exposed
    10 / 42 (23.81%)
    17 / 43 (39.53%)
         occurrences all number
    19
    40
    Asthenia
         subjects affected / exposed
    13 / 42 (30.95%)
    10 / 43 (23.26%)
         occurrences all number
    36
    26
    Pyrexia
         subjects affected / exposed
    10 / 42 (23.81%)
    5 / 43 (11.63%)
         occurrences all number
    10
    6
    Oedema peripheral
         subjects affected / exposed
    2 / 42 (4.76%)
    8 / 43 (18.60%)
         occurrences all number
    3
    15
    Pain
         subjects affected / exposed
    2 / 42 (4.76%)
    5 / 43 (11.63%)
         occurrences all number
    4
    5
    Chest pain
         subjects affected / exposed
    1 / 42 (2.38%)
    4 / 43 (9.30%)
         occurrences all number
    1
    4
    Chills
         subjects affected / exposed
    3 / 42 (7.14%)
    2 / 43 (4.65%)
         occurrences all number
    4
    2
    Oedema
         subjects affected / exposed
    0 / 42 (0.00%)
    3 / 43 (6.98%)
         occurrences all number
    0
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    10 / 42 (23.81%)
    19 / 43 (44.19%)
         occurrences all number
    14
    32
    Dyspnoea
         subjects affected / exposed
    5 / 42 (11.90%)
    13 / 43 (30.23%)
         occurrences all number
    5
    22
    Epistaxis
         subjects affected / exposed
    3 / 42 (7.14%)
    13 / 43 (30.23%)
         occurrences all number
    4
    18
    Pneumonitis
         subjects affected / exposed
    4 / 42 (9.52%)
    7 / 43 (16.28%)
         occurrences all number
    4
    11
    Dysphonia
         subjects affected / exposed
    2 / 42 (4.76%)
    3 / 43 (6.98%)
         occurrences all number
    2
    4
    Productive cough
         subjects affected / exposed
    1 / 42 (2.38%)
    3 / 43 (6.98%)
         occurrences all number
    1
    3
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    5 / 42 (11.90%)
    6 / 43 (13.95%)
         occurrences all number
    5
    7
    Investigations
    Weight decreased
         subjects affected / exposed
    9 / 42 (21.43%)
    4 / 43 (9.30%)
         occurrences all number
    12
    4
    Blood creatine increased
         subjects affected / exposed
    1 / 42 (2.38%)
    7 / 43 (16.28%)
         occurrences all number
    1
    11
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 42 (2.38%)
    3 / 43 (6.98%)
         occurrences all number
    1
    5
    Blood triglycerides increased
         subjects affected / exposed
    0 / 42 (0.00%)
    3 / 43 (6.98%)
         occurrences all number
    0
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 42 (14.29%)
    7 / 43 (16.28%)
         occurrences all number
    7
    11
    Dysgeusia
         subjects affected / exposed
    4 / 42 (9.52%)
    6 / 43 (13.95%)
         occurrences all number
    6
    8
    Lethargy
         subjects affected / exposed
    4 / 42 (9.52%)
    5 / 43 (11.63%)
         occurrences all number
    5
    8
    Dizziness
         subjects affected / exposed
    1 / 42 (2.38%)
    4 / 43 (9.30%)
         occurrences all number
    1
    7
    Paraesthesia
         subjects affected / exposed
    3 / 42 (7.14%)
    2 / 43 (4.65%)
         occurrences all number
    3
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    5 / 42 (11.90%)
    13 / 43 (30.23%)
         occurrences all number
    9
    33
    Thrombocytopenia
         subjects affected / exposed
    1 / 42 (2.38%)
    5 / 43 (11.63%)
         occurrences all number
    1
    11
    Eye disorders
    Lacrimation increased
         subjects affected / exposed
    3 / 42 (7.14%)
    1 / 43 (2.33%)
         occurrences all number
    3
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    22 / 42 (52.38%)
    23 / 43 (53.49%)
         occurrences all number
    44
    44
    Nausea
         subjects affected / exposed
    20 / 42 (47.62%)
    14 / 43 (32.56%)
         occurrences all number
    26
    16
    Vomiting
         subjects affected / exposed
    16 / 42 (38.10%)
    9 / 43 (20.93%)
         occurrences all number
    31
    12
    Constipation
         subjects affected / exposed
    8 / 42 (19.05%)
    13 / 43 (30.23%)
         occurrences all number
    11
    14
    Abdominal pain
         subjects affected / exposed
    8 / 42 (19.05%)
    9 / 43 (20.93%)
         occurrences all number
    10
    15
    Stomatitis
         subjects affected / exposed
    7 / 42 (16.67%)
    9 / 43 (20.93%)
         occurrences all number
    17
    14
    Dyspepsia
         subjects affected / exposed
    5 / 42 (11.90%)
    5 / 43 (11.63%)
         occurrences all number
    7
    5
    Abdominal pain upper
         subjects affected / exposed
    8 / 42 (19.05%)
    1 / 43 (2.33%)
         occurrences all number
    8
    1
    Dry mouth
         subjects affected / exposed
    3 / 42 (7.14%)
    5 / 43 (11.63%)
         occurrences all number
    4
    6
    Mouth ulceration
         subjects affected / exposed
    4 / 42 (9.52%)
    2 / 43 (4.65%)
         occurrences all number
    6
    2
    Gastrooesophageal reflux disease
         subjects affected / exposed
    3 / 42 (7.14%)
    1 / 43 (2.33%)
         occurrences all number
    3
    1
    Haemorrhoids
         subjects affected / exposed
    3 / 42 (7.14%)
    0 / 43 (0.00%)
         occurrences all number
    5
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    18 / 42 (42.86%)
    22 / 43 (51.16%)
         occurrences all number
    36
    37
    Pruritus
         subjects affected / exposed
    10 / 42 (23.81%)
    8 / 43 (18.60%)
         occurrences all number
    16
    9
    Dry skin
         subjects affected / exposed
    6 / 42 (14.29%)
    10 / 43 (23.26%)
         occurrences all number
    8
    13
    Rash maculo-papular
         subjects affected / exposed
    8 / 42 (19.05%)
    4 / 43 (9.30%)
         occurrences all number
    14
    4
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    3 / 42 (7.14%)
    5 / 43 (11.63%)
         occurrences all number
    5
    6
    Onychoclasis
         subjects affected / exposed
    1 / 42 (2.38%)
    6 / 43 (13.95%)
         occurrences all number
    2
    6
    Night sweats
         subjects affected / exposed
    5 / 42 (11.90%)
    1 / 43 (2.33%)
         occurrences all number
    7
    1
    Rash pruritic
         subjects affected / exposed
    0 / 42 (0.00%)
    4 / 43 (9.30%)
         occurrences all number
    0
    4
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 42 (0.00%)
    3 / 43 (6.98%)
         occurrences all number
    0
    4
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    3 / 42 (7.14%)
    6 / 43 (13.95%)
         occurrences all number
    3
    9
    Muscle spasms
         subjects affected / exposed
    4 / 42 (9.52%)
    4 / 43 (9.30%)
         occurrences all number
    10
    4
    Arthralgia
         subjects affected / exposed
    3 / 42 (7.14%)
    3 / 43 (6.98%)
         occurrences all number
    3
    5
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 42 (4.76%)
    4 / 43 (9.30%)
         occurrences all number
    2
    5
    Urinary tract infection
         subjects affected / exposed
    3 / 42 (7.14%)
    1 / 43 (2.33%)
         occurrences all number
    4
    1
    Lung infection
         subjects affected / exposed
    0 / 42 (0.00%)
    3 / 43 (6.98%)
         occurrences all number
    0
    3
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    24 / 42 (57.14%)
    9 / 43 (20.93%)
         occurrences all number
    64
    33
    Decreased appetite
         subjects affected / exposed
    18 / 42 (42.86%)
    10 / 43 (23.26%)
         occurrences all number
    30
    15
    Dehydration
         subjects affected / exposed
    3 / 42 (7.14%)
    2 / 43 (4.65%)
         occurrences all number
    4
    2
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 42 (2.38%)
    3 / 43 (6.98%)
         occurrences all number
    1
    7
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 42 (0.00%)
    3 / 43 (6.98%)
         occurrences all number
    0
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Aug 2011
    The eligibility criteria was updated to include an exclusion criteria of: hypersensitivity to any rapamycin derivatives or to any excipients of everolimus.
    23 May 2012
    The study was amended for updates to the management of hyperglycemia to reflect current best practices.

    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.
    None reported
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    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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