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    Clinical Trial Results:
    A PHASE II, RANDOMIZED STUDY OF PACLITAXEL WITH GDC-0941 VERSUS PACLITAXEL WITH PLACEBO IN PATIENTS WITH LOCALLY RECURRENT OR METASTATIC BREAST CANCER

    Summary
    EudraCT number
    		 2012-003262-41
    Trial protocol
    		 BE   AT   CZ   GB   ES  
    Global end of trial date
    10 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Dec 2016
    First version publication date
    07 Dec 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GO28509
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01740336
    WHO universal trial number (UTN)
    		 -
    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
    10 Dec 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy (as measured by progression-free survival [PFS]) of paclitaxel + GDC-0941 versus paclitaxel + placebo in subjects with and without phosphatidylinositol-4,5-bisphosphate 3-kinase (PIK3CA) mutations and in all treated subjects
    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
    12 Feb 2013
    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
    Spain: 7
    Country: Number of subjects enrolled
    United Kingdom: 37
    Country: Number of subjects enrolled
    Austria: 3
    Country: Number of subjects enrolled
    Belgium: 26
    Country: Number of subjects enrolled
    Czech Republic: 18
    Country: Number of subjects enrolled
    Australia: 24
    Country: Number of subjects enrolled
    United States: 51
    Country: Number of subjects enrolled
    Korea, Republic of: 13
    Worldwide total number of subjects
    179
    EEA total number of subjects
    91
    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)
    139
    From 65 to 84 years
    40
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects with locally recurrent or metastatic HER2-negative,hormone receptor (HR) positive breast cancer previously untreated with chemotherapy in the metastatic setting (with the exception of capecitabine) were enrolled globally from 8 countries.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo + Paclitaxel
    Arm description
    		 Subjects received matching placebo to GDC-0941 along with Paclitaxel weekly for 3 out of 4 weeks in every 28-day cycle.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received matching placebo to GDC-0941 260 once daily, orally beginning on cycle 1, Day 1 for 5 consecutive days followed by 2 consecutive days without treatment, repeated weekly in each 28-day cycle until progressive disease or intolerable toxicity.

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received Paclitaxel intravenously (IV) at 90 milligram per metre square (mg/m^2) weekly for 3 of every 4 weeks (28-day cycle).

    Arm title
    		 Paclitaxel + GDC-0941
    Arm description
    		 Subjects received GDC-0941 administered in repeated rounds of once daily dosing for 5 consecutive days followed by 2 consecutive days during which GDC-0941 is not administered (5/7-day schedule) along with Paclitaxel weekly for 3 out of 4 weeks in every 28-day cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received Paclitaxel IV at 90 mg/m^2 weekly for 3 of every 4 weeks (28-day cycle).

    Investigational medicinal product name
    GDC-0941
    Investigational medicinal product code
    Other name
    Pictilisib
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received GDC-0941 260 mgs once daily beginning on cycle 1, Day 1 for 5 consecutive days followed by 2 consecutive days without GDC-0941 treatment and repeated weekly in each 28-day cycle until disease progression or intolerable toxicity.

    Number of subjects in period 1
    		Placebo + Paclitaxel Paclitaxel + GDC-0941
    Started
    92
    87
    Completed
    0
    0
    Not completed
    92
    87
         Death
    31
    32
         Other
    6
    10
         Study terminated by sponsor
    44
    39
         Lost to follow-up
    1
    1
         Withdrawal by subject
    10
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo + Paclitaxel
    Reporting group description
    		 Subjects received matching placebo to GDC-0941 along with Paclitaxel weekly for 3 out of 4 weeks in every 28-day cycle.

    Reporting group title
    Paclitaxel + GDC-0941
    Reporting group description
    		 Subjects received GDC-0941 administered in repeated rounds of once daily dosing for 5 consecutive days followed by 2 consecutive days during which GDC-0941 is not administered (5/7-day schedule) along with Paclitaxel weekly for 3 out of 4 weeks in every 28-day cycle.

    Reporting group values
    		 Placebo + Paclitaxel Paclitaxel + GDC-0941 Total
    Number of subjects
    		 92 87 179
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 57.2 ± 10.1 54.5 ± 11.3 -
    Gender categorical
    Units: Subjects
        Female
    		 92 87 179
        Male
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Placebo + Paclitaxel
    Reporting group description
    		 Subjects received matching placebo to GDC-0941 along with Paclitaxel weekly for 3 out of 4 weeks in every 28-day cycle.

    Reporting group title
    Paclitaxel + GDC-0941
    Reporting group description
    		 Subjects received GDC-0941 administered in repeated rounds of once daily dosing for 5 consecutive days followed by 2 consecutive days during which GDC-0941 is not administered (5/7-day schedule) along with Paclitaxel weekly for 3 out of 4 weeks in every 28-day cycle.

    Primary: Progression Free-Survival (PFS) Assessed by Investigator

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    End point title
    		 Progression Free-Survival (PFS) Assessed by Investigator
    End point description
    PFS is defined as time from randomisation to the first occurrence of disease progression as determined by investigator review of tumor assessments using modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death on study from any cause (less than or equal to [<=] 30 days after the last dose of study treatment). As per modified RECIST v1.1 criteria, Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimetre (mm). The appearance of one or more new lesions is also considered progression. Results reported as cumulative data. Analysis population included all randomised subjects.
    End point type
    Primary
    End point timeframe
    From the time of randomization to the progression of disease or death from any cause (<=30 days after the last dose of study treatment) at data cut-off date 12 September 2014 (planned efficacy analysis) in blinded period (Up to 19 months)
    End point values
    		 Placebo + Paclitaxel Paclitaxel + GDC-0941
    Number of subjects analysed
    92
    87
    Units: months
        median (confidence interval 95%)
    7.3 (5.8 to 8.5)
    8.2 (5.9 to 9.9)
    Statistical analysis title
    		 PFS
    Statistical analysis description
    Hazard ratios were estimated by Cox regression.
    Comparison groups
    Placebo + Paclitaxel v Paclitaxel + GDC-0941
    Number of subjects included in analysis
    179
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.835
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 1.46

    Secondary: Objective Response Rate (ORR)

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    End point title
    		 Objective Response Rate (ORR)
    End point description
    ORR is defined as complete response (CR) or partial response (PR) using modified RECIST v1.1 criteria. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 mm; PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Results reported as cumulative data. Analysis population included all randomised subjects.
    End point type
    Secondary
    End point timeframe
    From the time of randomization to the data cut-off date 12 September 2014 (planned efficacy analysis) in blinded period (Up to 19 months)
    End point values
    		 Placebo + Paclitaxel Paclitaxel + GDC-0941
    Number of subjects analysed
    92
    87
    Units: percentage of subjects
        number (confidence interval 95%)
    20.7 (12.92 to 30.36)
    23 (14.64 to 33.25)
    Statistical analysis title
    		 ORR
    Comparison groups
    Placebo + Paclitaxel v Paclitaxel + GDC-0941
    Number of subjects included in analysis
    179
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7051
    Method
    		 Chi-squared
    Parameter type
    		 Difference in Response Rates
    Point estimate
    2.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.77
         upper limit
    		 14.44

    Secondary: Duration of Response (DOR)

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    End point title
    		 Duration of Response (DOR)
    End point description
    DOR is defined as the time interval between the date of the earliest qualifying response and the earliest date of PD or death from any cause (<=30 days after the last dose of study treatment). Results reported as cumulative data. Analysis population included all randomised subjects with qualifying response in blinded period. Here, 99999 indicates upper limit of confidence interval (CI) as it was not estimable.
    End point type
    Secondary
    End point timeframe
    Date of the earliest qualifying response until the earliest date of PD or death from any cause (<=30 days after the last dose of study treatment) at data cut-off date 12 Sep 2014 in blinded period (Up to 19 months)
    End point values
    		 Placebo + Paclitaxel Paclitaxel + GDC-0941
    Number of subjects analysed
    19 [1]
    20 [2]
    Units: months
        median (confidence interval 95%)
    5.62 (4.86 to 99999)
    6.8 (5.19 to 99999)
    Notes
    [1] - Number of subjects analysed for this endpoint.
    [2] - Number of subjects analysed for this endpoint.
    Statistical analysis title
    		 DOR
    Comparison groups
    Placebo + Paclitaxel v Paclitaxel + GDC-0941
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9052
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.24
         upper limit
    		 4.9

    Secondary: Clinical Benefit Rate (CBR)

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    End point title
    		 Clinical Benefit Rate (CBR)
    End point description
    CBR is defined as the percentage of subjects with confirmed CR, PR, or stable disease as assessed according to modified RECIST v1.1. CR: disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to < 10 mm. PR: ≥ 30% decrease in the sum of diameters of target lesions, compared to the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, compared to the baseline sum diameters.
    End point type
    Secondary
    End point timeframe
    Up to 38 months
    End point values
    		 Placebo + Paclitaxel Paclitaxel + GDC-0941
    Number of subjects analysed
    0 [3]
    0 [4]
    Units: percentage of subjects
        number (not applicable)
    Notes
    [3] - Data not analysed as per planned, hence not reported.
    [4] - Data not analysed as per planned, hence not reported.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With any Adverse Event (AE)

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    End point title
    		 Percentage of Subjects With any Adverse Event (AE)
    End point description
    An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The safety population included those subjects who had received any amount of study treatment. Safety data was collected for overall study period (blinded + open-label period).
    End point type
    Secondary
    End point timeframe
    For overall study period (blinded + open-label period), Up to 38 months
    End point values
    		 Placebo + Paclitaxel Paclitaxel + GDC-0941
    Number of subjects analysed
    92
    87
    Units: percentage of subjects
        number (not applicable)
    100
    100
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    For overall study period (blinded + open-label period)
    Adverse event reporting additional description
    The safety population included those subjects who had received any amount of study treatment. Safety data was collected for overall study period (blinded + open-label period).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Placebo + Paclitaxel
    Reporting group description
    		 Subjects received matching placebo to GDC-0941 along with Paclitaxel weekly for 3 out of 4 weeks in every 28-day cycle.

    Reporting group title
    Paclitaxel + GDC-0941
    Reporting group description
    		 Subjects received GDC-0941 administered in repeated rounds of once daily dosing for 5 consecutive days followed by 2 consecutive days during which GDC-0941 is not administered (5/7-day schedule) along with Paclitaxel weekly for 3 out of 4 weeks in every 28-day cycle.

    Serious adverse events
    		 Placebo + Paclitaxel Paclitaxel + GDC-0941
    Total subjects affected by serious adverse events
         subjects affected / exposed
    31 / 92 (33.70%)
    34 / 87 (39.08%)
         number of deaths (all causes)
    6
    4
         number of deaths resulting from adverse events
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    4 / 92 (4.35%)
    2 / 87 (2.30%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 3
    0 / 2
    Breast cancer metastatic
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphoedema
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis limb
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Central venous catheter removal
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    5 / 92 (5.43%)
    3 / 87 (3.45%)
         occurrences causally related to treatment / all
    3 / 5
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    1 / 92 (1.09%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    1 / 92 (1.09%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis
         subjects affected / exposed
    3 / 92 (3.26%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    3 / 3
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Pleural effusion
         subjects affected / exposed
    3 / 92 (3.26%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 92 (0.00%)
    2 / 87 (2.30%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 92 (0.00%)
    2 / 87 (2.30%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Asthma
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Investigations
    Electrocardiogram T wave inversion
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 92 (2.17%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    0 / 92 (0.00%)
    2 / 87 (2.30%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Microangiopathic haemolytic anaemia
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Deafness unilateral
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    2 / 92 (2.17%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    2 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal distension
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric volvulus
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic cirrhosis
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hepatic fibrosis
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic function abnormal
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic haemorrhage
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Jaundice cholestatic
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 87 (1.15%)
         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
    Angioedema
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash maculo-papular
         subjects affected / exposed
    0 / 92 (0.00%)
    3 / 87 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis allergic
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 92 (2.17%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone pain
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint swelling
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pathological fracture
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 87 (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
    Cellulitis
         subjects affected / exposed
    2 / 92 (2.17%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 92 (0.00%)
    3 / 87 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    1 / 92 (1.09%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 92 (1.09%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 92 (2.17%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    2 / 92 (2.17%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 92 (1.09%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 92 (2.17%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atypical pneumonia
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catheter site infection
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related sepsis
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 87 (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
    0 / 92 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 87 (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
    0 / 92 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis viral
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salmonellosis
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Tetany
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 87 (1.15%)
         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
    		 Placebo + Paclitaxel Paclitaxel + GDC-0941
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    92 / 92 (100.00%)
    87 / 87 (100.00%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    12 / 92 (13.04%)
    7 / 87 (8.05%)
         occurrences all number
    15
    7
    Hypertension
         subjects affected / exposed
    6 / 92 (6.52%)
    9 / 87 (10.34%)
         occurrences all number
    11
    13
    Lymphoedema
         subjects affected / exposed
    7 / 92 (7.61%)
    8 / 87 (9.20%)
         occurrences all number
    7
    9
    Flushing
         subjects affected / exposed
    8 / 92 (8.70%)
    3 / 87 (3.45%)
         occurrences all number
    11
    6
    Hypotension
         subjects affected / exposed
    6 / 92 (6.52%)
    3 / 87 (3.45%)
         occurrences all number
    9
    6
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    53 / 92 (57.61%)
    57 / 87 (65.52%)
         occurrences all number
    99
    116
    Oedema peripheral
         subjects affected / exposed
    17 / 92 (18.48%)
    21 / 87 (24.14%)
         occurrences all number
    22
    38
    Pyrexia
         subjects affected / exposed
    9 / 92 (9.78%)
    15 / 87 (17.24%)
         occurrences all number
    9
    18
    Asthenia
         subjects affected / exposed
    12 / 92 (13.04%)
    9 / 87 (10.34%)
         occurrences all number
    20
    20
    Pain
         subjects affected / exposed
    4 / 92 (4.35%)
    10 / 87 (11.49%)
         occurrences all number
    6
    11
    Mucosal inflammation
         subjects affected / exposed
    6 / 92 (6.52%)
    5 / 87 (5.75%)
         occurrences all number
    7
    5
    Chest pain
         subjects affected / exposed
    5 / 92 (5.43%)
    4 / 87 (4.60%)
         occurrences all number
    5
    5
    Chills
         subjects affected / exposed
    3 / 92 (3.26%)
    5 / 87 (5.75%)
         occurrences all number
    3
    7
    Face oedema
         subjects affected / exposed
    1 / 92 (1.09%)
    5 / 87 (5.75%)
         occurrences all number
    1
    12
    Influenza like illness
         subjects affected / exposed
    1 / 92 (1.09%)
    5 / 87 (5.75%)
         occurrences all number
    1
    6
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    23 / 92 (25.00%)
    27 / 87 (31.03%)
         occurrences all number
    28
    41
    Dyspnoea
         subjects affected / exposed
    15 / 92 (16.30%)
    28 / 87 (32.18%)
         occurrences all number
    27
    41
    Epistaxis
         subjects affected / exposed
    9 / 92 (9.78%)
    10 / 87 (11.49%)
         occurrences all number
    12
    12
    Oropharyngeal pain
         subjects affected / exposed
    9 / 92 (9.78%)
    10 / 87 (11.49%)
         occurrences all number
    10
    14
    Dysphonia
         subjects affected / exposed
    5 / 92 (5.43%)
    0 / 87 (0.00%)
         occurrences all number
    5
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    19 / 92 (20.65%)
    14 / 87 (16.09%)
         occurrences all number
    24
    18
    Anxiety
         subjects affected / exposed
    11 / 92 (11.96%)
    9 / 87 (10.34%)
         occurrences all number
    11
    9
    Depression
         subjects affected / exposed
    11 / 92 (11.96%)
    8 / 87 (9.20%)
         occurrences all number
    11
    11
    Investigations
    Alanine Aminotransferase increased
         subjects affected / exposed
    16 / 92 (17.39%)
    8 / 87 (9.20%)
         occurrences all number
    33
    14
    Neutrophil count decreased
         subjects affected / exposed
    11 / 92 (11.96%)
    9 / 87 (10.34%)
         occurrences all number
    22
    38
    Aspartate aminotransferase increased
         subjects affected / exposed
    13 / 92 (14.13%)
    6 / 87 (6.90%)
         occurrences all number
    32
    9
    White blood cell count decreased
         subjects affected / exposed
    8 / 92 (8.70%)
    6 / 87 (6.90%)
         occurrences all number
    33
    14
    Weight decreased
         subjects affected / exposed
    4 / 92 (4.35%)
    8 / 87 (9.20%)
         occurrences all number
    4
    11
    Blood alkaline phosphatase increased
         subjects affected / exposed
    6 / 92 (6.52%)
    4 / 87 (4.60%)
         occurrences all number
    8
    8
    Weight increased
         subjects affected / exposed
    6 / 92 (6.52%)
    0 / 87 (0.00%)
         occurrences all number
    6
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 92 (1.09%)
    6 / 87 (6.90%)
         occurrences all number
    1
    6
    Nervous system disorders
    Neuropathy peripheral
         subjects affected / exposed
    34 / 92 (36.96%)
    26 / 87 (29.89%)
         occurrences all number
    66
    52
    Dysgeusia
         subjects affected / exposed
    28 / 92 (30.43%)
    29 / 87 (33.33%)
         occurrences all number
    41
    31
    Headache
         subjects affected / exposed
    19 / 92 (20.65%)
    27 / 87 (31.03%)
         occurrences all number
    26
    44
    Peripheral sensory neuropathy
         subjects affected / exposed
    22 / 92 (23.91%)
    22 / 87 (25.29%)
         occurrences all number
    39
    40
    Paraesthesia
         subjects affected / exposed
    16 / 92 (17.39%)
    14 / 87 (16.09%)
         occurrences all number
    30
    21
    Dizziness
         subjects affected / exposed
    12 / 92 (13.04%)
    10 / 87 (11.49%)
         occurrences all number
    14
    12
    Hypoaesthesia
         subjects affected / exposed
    3 / 92 (3.26%)
    8 / 87 (9.20%)
         occurrences all number
    3
    14
    Lethargy
         subjects affected / exposed
    6 / 92 (6.52%)
    3 / 87 (3.45%)
         occurrences all number
    10
    4
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    35 / 92 (38.04%)
    13 / 87 (14.94%)
         occurrences all number
    72
    39
    Neutropenia
         subjects affected / exposed
    23 / 92 (25.00%)
    23 / 87 (26.44%)
         occurrences all number
    45
    71
    Leukopenia
         subjects affected / exposed
    7 / 92 (7.61%)
    8 / 87 (9.20%)
         occurrences all number
    25
    30
    Thrombocytopenia
         subjects affected / exposed
    2 / 92 (2.17%)
    6 / 87 (6.90%)
         occurrences all number
    4
    6
    Eye disorders
    Vision blurred
         subjects affected / exposed
    8 / 92 (8.70%)
    3 / 87 (3.45%)
         occurrences all number
    8
    4
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    51 / 92 (55.43%)
    47 / 87 (54.02%)
         occurrences all number
    93
    93
    Diarrhoea
         subjects affected / exposed
    39 / 92 (42.39%)
    50 / 87 (57.47%)
         occurrences all number
    72
    129
    Vomiting
         subjects affected / exposed
    22 / 92 (23.91%)
    32 / 87 (36.78%)
         occurrences all number
    58
    56
    Constipation
         subjects affected / exposed
    30 / 92 (32.61%)
    23 / 87 (26.44%)
         occurrences all number
    39
    27
    Dyspepsia
         subjects affected / exposed
    18 / 92 (19.57%)
    13 / 87 (14.94%)
         occurrences all number
    24
    17
    Abdominal pain
         subjects affected / exposed
    16 / 92 (17.39%)
    12 / 87 (13.79%)
         occurrences all number
    21
    14
    Stomatitis
         subjects affected / exposed
    13 / 92 (14.13%)
    15 / 87 (17.24%)
         occurrences all number
    17
    20
    Dry mouth
         subjects affected / exposed
    8 / 92 (8.70%)
    9 / 87 (10.34%)
         occurrences all number
    8
    9
    Abdominal pain upper
         subjects affected / exposed
    8 / 92 (8.70%)
    8 / 87 (9.20%)
         occurrences all number
    13
    8
    Gastrooesophageal reflux disease
         subjects affected / exposed
    5 / 92 (5.43%)
    8 / 87 (9.20%)
         occurrences all number
    6
    9
    Mouth ulceration
         subjects affected / exposed
    4 / 92 (4.35%)
    5 / 87 (5.75%)
         occurrences all number
    4
    6
    Abdominal distension
         subjects affected / exposed
    3 / 92 (3.26%)
    5 / 87 (5.75%)
         occurrences all number
    3
    5
    Oral pain
         subjects affected / exposed
    5 / 92 (5.43%)
    2 / 87 (2.30%)
         occurrences all number
    7
    2
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    57 / 92 (61.96%)
    50 / 87 (57.47%)
         occurrences all number
    69
    63
    Rash
         subjects affected / exposed
    26 / 92 (28.26%)
    32 / 87 (36.78%)
         occurrences all number
    42
    57
    Pruritus
         subjects affected / exposed
    12 / 92 (13.04%)
    13 / 87 (14.94%)
         occurrences all number
    18
    14
    Rash maculo-papular
         subjects affected / exposed
    5 / 92 (5.43%)
    19 / 87 (21.84%)
         occurrences all number
    9
    34
    Nail disorder
         subjects affected / exposed
    10 / 92 (10.87%)
    6 / 87 (6.90%)
         occurrences all number
    13
    9
    Erythema
         subjects affected / exposed
    11 / 92 (11.96%)
    4 / 87 (4.60%)
         occurrences all number
    14
    8
    Dry skin
         subjects affected / exposed
    6 / 92 (6.52%)
    7 / 87 (8.05%)
         occurrences all number
    6
    14
    Nail discolouration
         subjects affected / exposed
    6 / 92 (6.52%)
    4 / 87 (4.60%)
         occurrences all number
    7
    4
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    21 / 92 (22.83%)
    16 / 87 (18.39%)
         occurrences all number
    31
    23
    Back pain
         subjects affected / exposed
    22 / 92 (23.91%)
    14 / 87 (16.09%)
         occurrences all number
    31
    16
    Pain in extremity
         subjects affected / exposed
    18 / 92 (19.57%)
    17 / 87 (19.54%)
         occurrences all number
    23
    21
    Myalgia
         subjects affected / exposed
    21 / 92 (22.83%)
    13 / 87 (14.94%)
         occurrences all number
    30
    21
    Bone pain
         subjects affected / exposed
    6 / 92 (6.52%)
    6 / 87 (6.90%)
         occurrences all number
    7
    6
    Musculoskeletal chest pain
         subjects affected / exposed
    8 / 92 (8.70%)
    4 / 87 (4.60%)
         occurrences all number
    10
    4
    Musculoskeletal pain
         subjects affected / exposed
    8 / 92 (8.70%)
    2 / 87 (2.30%)
         occurrences all number
    8
    2
    Muscle spasms
         subjects affected / exposed
    5 / 92 (5.43%)
    3 / 87 (3.45%)
         occurrences all number
    5
    3
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    11 / 92 (11.96%)
    12 / 87 (13.79%)
         occurrences all number
    15
    13
    Nasopharyngitis
         subjects affected / exposed
    14 / 92 (15.22%)
    7 / 87 (8.05%)
         occurrences all number
    17
    8
    Urinary tract infection
         subjects affected / exposed
    6 / 92 (6.52%)
    9 / 87 (10.34%)
         occurrences all number
    12
    12
    Oral candidiasis
         subjects affected / exposed
    3 / 92 (3.26%)
    6 / 87 (6.90%)
         occurrences all number
    3
    6
    Sinusitis
         subjects affected / exposed
    6 / 92 (6.52%)
    2 / 87 (2.30%)
         occurrences all number
    7
    3
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    16 / 92 (17.39%)
    26 / 87 (29.89%)
         occurrences all number
    29
    37
    Hyperglycaemia
         subjects affected / exposed
    11 / 92 (11.96%)
    7 / 87 (8.05%)
         occurrences all number
    33
    24
    Hypokalaemia
         subjects affected / exposed
    5 / 92 (5.43%)
    11 / 87 (12.64%)
         occurrences all number
    9
    13
    Hypomagnesaemia
         subjects affected / exposed
    8 / 92 (8.70%)
    5 / 87 (5.75%)
         occurrences all number
    19
    6
    Hypocalcaemia
         subjects affected / exposed
    4 / 92 (4.35%)
    7 / 87 (8.05%)
         occurrences all number
    6
    7
    Dehydration
         subjects affected / exposed
    5 / 92 (5.43%)
    5 / 87 (5.75%)
         occurrences all number
    8
    8

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Sep 2012
    1. The eligibility criteria were modified to clarify that only women  ³ 18 years of age would be eligible for enrollment 2. The following adverse events of special interest were added that would require immediate reporting to the Sponsor for real-time monitoring in order to enhance subject safety: cases of potential drug-induced liver injury including an elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy’s law. Suspected transmission of an infectious agent by the study drug 4. Abnormal Liver Function Tests was added to provide guidance for detecting and reporting liver function abnormalities 5. More detailed dose modification guidance for rash and hyperglycemia was added 6. “Rationale for the Collection of a Blood Sample for Analysis of Circulating Biomarkers” was added to clarify the rationale for collecting the baseline plasma biomarker sample 7. Typographical errors were corrected to improve clarity and consistency
    19 Oct 2012
    To clarify that participation in this study is limited to female subjects.
    26 Jan 2013
    1. Remove the requirement that steroid therapy must have been concluded greater than 2 weeks prior to Cycle 1 Day 1 2. Decrease the interval between the completion of radiotherapy and Cycle 1, Day 1 for the treatment of central nervous system disease
    22 Dec 2014
    1. The protocol-specified interim analysis for efficacy demonstrated that subjects receiving GDC-0941 with paclitaxel did not have a longer progression-free survival (primary endpoint) or an improved overall response rate (secondary endpoint) in both the all-comer population and the PIK3CA mutant population compared with subjects who received placebo with paclitaxel. Safety data from this study are consistent with data generated to date in other clinical trials involving GDC-0941 either as a single agent or in combination with paclitaxel. Based on the lack of clinical benefit, the Sponsor has recommended that investigators discontinue GDC‑0941 for subjects who are receiving GDC-0941 on the study; the decision to continue or discontinue treatment with GDC-0941 or paclitaxel is at the discretion of the investigator following consultation with the subject 2. This amendment to Protocol GO28509 will reduce the protocol-specified assessments for subjects who are either on active study treatment (GDC-0941 with paclitaxel or paclitaxel alone) or in the survival follow-up period.Subjects who are receiving study treatment will be allowed to continue treatment until disease progression, the onset of treatment-limiting toxicity, or when the treating physician decides to discontinue treatment, whichever occurs first. This protocol amendment will reduce the number and type of assessments required for the evaluation of study treatment

    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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