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    Clinical Trial Results:
    An open-label Phase II study of BKM120 in subjects with relapsed and refractory diffuse large B-cell lymphoma, mantle cell lymphoma and follicular lymphoma Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com/CtrdWeb/home.nov for complete trial results.

    Summary
    EudraCT number
    		 2012-002208-41
    Trial protocol
    		 DE   IT   ES   BE  
    Global end of trial date
    20 Jul 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Aug 2018
    First version publication date
    04 Aug 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CBKM120Z2402
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01693614
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@novartis.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
    20 Jul 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Jul 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Determine the efficacy of buparlisib in subjects with relapsed/refractory Non-Hodgkin Lymphoma (NHL) in the three different histological subgroups (cohorts).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Feb 2013
    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
    Belgium: 4
    Country: Number of subjects enrolled
    France: 9
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    Italy: 8
    Country: Number of subjects enrolled
    Korea, Republic of: 7
    Country: Number of subjects enrolled
    Spain: 9
    Country: Number of subjects enrolled
    Turkey: 7
    Country: Number of subjects enrolled
    United States: 25
    Worldwide total number of subjects
    72
    EEA total number of subjects
    33
    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)
    34
    From 65 to 84 years
    37
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Seventy-two patients were enrolled in the study and received treatment. Primary reason for not completing is presented

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 DLBCL Cohort
    Arm description
    		 Diffuse large B-cell lymphoma cohort
    Arm type
    		 Experimental

    Investigational medicinal product name
    buparlisib
    Investigational medicinal product code
    BKM120
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg was administered orally once daily on a continuous dosing schedule for 28 days (treatment cycle)

    Arm title
    		 MCL Cohort
    Arm description
    		 Mantle cell lymphoma cohort
    Arm type
    		 Experimental

    Investigational medicinal product name
    buparlisib
    Investigational medicinal product code
    BKM120
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg was administered orally once daily on a continuous dosing schedule for 28 days (treatment cycle)

    Arm title
    		 FL Cohort
    Arm description
    		 Follicular lymphoma cohort
    Arm type
    		 Experimental

    Investigational medicinal product name
    buparlisib
    Investigational medicinal product code
    BKM120
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg was administered orally once daily on a continuous dosing schedule for 28 days (treatment cycle)

    Number of subjects in period 1
    		DLBCL Cohort MCL Cohort FL Cohort
    Started
    26
    22
    24
    Completed
    0
    0
    0
    Not completed
    26
    22
    24
         Adverse event, serious fatal
    1
    -
    -
         Physician decision
    1
    1
    4
         Consent withdrawn by subject
    1
    -
    7
         Disease progression
    11
    8
    7
         Adverse event, non-fatal
    7
    11
    5
         Protocol deviation
    5
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    DLBCL Cohort
    Reporting group description
    		 Diffuse large B-cell lymphoma cohort

    Reporting group title
    MCL Cohort
    Reporting group description
    		 Mantle cell lymphoma cohort

    Reporting group title
    FL Cohort
    Reporting group description
    		 Follicular lymphoma cohort

    Reporting group values
    		 DLBCL Cohort MCL Cohort FL Cohort Total
    Number of subjects
    		 26 22 24 72
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 13 8 13 34
        From 65-84 years
    		 13 14 10 37
        85 years and over
    		 0 0 1 1
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 60.0 ( 14.57 ) 67.9 ( 8.56 ) 61.4 ( 13.11 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 8 4 11 23
        Male
    		 18 18 13 49
    Race/Ethnicity, Customized
    Units: Subjects
        Caucasian|
    		 19 17 21 57
        Black|
    		 0 0 1 1
        Asian|
    		 3 2 2 7
        Other|
    		 4 3 0 7

    End points

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    End points reporting groups
    Reporting group title
    DLBCL Cohort
    Reporting group description
    		 Diffuse large B-cell lymphoma cohort

    Reporting group title
    MCL Cohort
    Reporting group description
    		 Mantle cell lymphoma cohort

    Reporting group title
    FL Cohort
    Reporting group description
    		 Follicular lymphoma cohort

    Primary: Overall Response Rate (ORR) per investigator at 6 months (FAS)

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    End point title
    		 Overall Response Rate (ORR) per investigator at 6 months (FAS) [1]
    End point description
    Overall Response rate is the number of patients in a cohort who experience either complete response (CR) or partial response (PR) during their follow-up after treatment start divided by the total number of patients included in the corresponding cohort according to Cheson criteria The analysis for each cohort was based on an exact binomial test comparing the ORR to the reference level of 10% (null hypothesis) in the FAS. The test for each cohort used a significance level of 5%. The ORR was presented together with an exact 95% Clopper- Pearson confidence interval. Disease Control Rate (DCR) is the number of patients with CR, PR or SD (stable disease). Patients for whom the best response after treatment start was missing, unknown (UNK) or progressive disease (PD) were considered non-responders and were counted in the denominator for the estimation of the ORR
    End point type
    Primary
    End point timeframe
    Baseline up to 6 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: Analysis described in Primary Outcome description
    End point values
    		 DLBCL Cohort MCL Cohort FL Cohort
    Number of subjects analysed
    26
    22
    24
    Units: percentage of participants
    number (confidence interval 95%)
        ORR (3,5,6)|
    11.5 (2.45 to 30.15)
    22.7 (7.82 to 45.37)
    25.0 (9.77 to 46.71)
        DCR (n=8,18,21)|
    30.8 (14.33 to 51.79)
    81.8 (59.72 to 94.81)
    87.5 (67.64 to 97.34)
    No statistical analyses for this end point

    Primary: Percentage of participants with responses at 6 months (FAS)

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    End point title
    		 Percentage of participants with responses at 6 months (FAS) [2]
    End point description
    Complete Response (CR) = complete disappearance of all index extranodal lesions, Partial Response (PR) = At least 50% decrease from baseline in the SPD restricted to all index extranodal lesions, Stable Disease (SD) = Failure to attain the criteria needed for CR or PR and failure to fulfill the criteria for PD, Progressive Disease (PD) = At least a 50% increase from nadir2 in the SPD restricted to all index extranodal lesions. Nadir is defined as the smallest sum of the product of the diameters restricted to all index extranodal lesions recorded so far, at or after baseline. At each assessment, response will be first assessed for meeting CR status. If CR status is not met, response will be assessed for PD status, then PR status and SD status.
    End point type
    Primary
    End point timeframe
    Baseline up to approximately 6 months
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Analysis described in Primary Outcome description
    End point values
    		 DLBCL Cohort MCL Cohort FL Cohort
    Number of subjects analysed
    26
    22
    24
    Units: percentage of participants
    number (not applicable)
        CR (1,1,0)|
    3.8
    4.5
    0
        PR ( n=2,4,6)|
    7.7
    18.2
    25.0
        SD (n=5,13,15)|
    19.2
    59.1
    62.5
        PD (n=12,2,1)|
    46.2
    9.1
    4.2
        Unknown (n=6,2,2)|
    23.1
    9.1
    8.3
    No statistical analyses for this end point

    Secondary: Progression- Free Survival (PFS) based on investigator assessment (FAS)

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    End point title
    		 Progression- Free Survival (PFS) based on investigator assessment (FAS)
    End point description
    Progression-free survival (PFS) is the time from the date of treatment start to the date of the first documented progressive disease (PD) or death due to any cause using Kaplan-Meier method by cohort.
    End point type
    Secondary
    End point timeframe
    Baseline up to approximately 18 months
    End point values
    		 DLBCL Cohort MCL Cohort FL Cohort
    Number of subjects analysed
    26
    22
    24
    Units: months
        median (confidence interval 95%)
    1.8 (1.51 to 4.01)
    11.3 (3.81 to 38.90)
    9.1 (3.75 to 14.46)
    No statistical analyses for this end point

    Secondary: Duration of response for diffuse large B-cell lymphoma (DLBCL), and follicular lymphoma (FL) cohorts (FAS)

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    End point title
    		 Duration of response for diffuse large B-cell lymphoma (DLBCL), and follicular lymphoma (FL) cohorts (FAS) [3]
    End point description
    Duration of response is the time from the date of first occurrence of complete response (CR) or partial response (PR) to the date of the first documented progressive disease (PD) or death due to any cause.
    End point type
    Secondary
    End point timeframe
    Baseline up to approximately 18 months
    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: Only two cohorts met the criteria of duration of response.
    End point values
    		 DLBCL Cohort FL Cohort
    Number of subjects analysed
    3
    6
    Units: weeks
        median (confidence interval 95%)
    2.2 (1.15 to 9.99)
    11 (3.94 to 99.9)
    No statistical analyses for this end point

    Secondary: Overall survival (FAS)

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    End point title
    		 Overall survival (FAS)
    End point description
    Overall survival (OS) is the time from treatment start to the date of death due to any cause
    End point type
    Secondary
    End point timeframe
    Baseline up to approximately 18 months
    End point values
    		 DLBCL Cohort MCL Cohort FL Cohort
    Number of subjects analysed
    26
    22
    24
    Units: events
    number (not applicable)
        OS events (n=13,5,2)|
    50.0
    22.7
    8.3
        Number censored (n=13,17,22)|
    50.0
    77.3
    91.7
    No statistical analyses for this end point

    Secondary: Overall survival- Median (FAS)

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    End point title
    		 Overall survival- Median (FAS)
    End point description
    Overall survival (OS) is the time from treatment start to the date of death due to any cause. Estimates done by cohort using Kaplan-Meier method with 95% confidence intervals. 999 values = not estimable
    End point type
    Secondary
    End point timeframe
    Baseline up to approximately 18 months
    End point values
    		 DLBCL Cohort MCL Cohort FL Cohort
    Number of subjects analysed
    26
    22
    24
    Units: months
        median (confidence interval 95%)
    5.2 (3.06 to 9.9)
    99.99 (15.64 to 99.99)
    99.99 (22.74 to 99.99)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV).  All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 18 months
    Adverse event reporting additional description
    Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field “number of deaths resulting from adverse events” all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    DLBCL Cohort
    Reporting group description
    		 DLBCL

    Reporting group title
    FL Cohort
    Reporting group description
    		 FL

    Reporting group title
    MCL Cohort
    Reporting group description
    		 MCL

    Serious adverse events
    		 DLBCL Cohort FL Cohort MCL Cohort
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 26 (46.15%)
    7 / 24 (29.17%)
    12 / 22 (54.55%)
         number of deaths (all causes)
    7
    0
    1
         number of deaths resulting from adverse events
    1
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant neoplasm progression
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 24 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Gait disturbance
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 24 (4.17%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 24 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 24 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Performance status decreased
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung infiltration
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 24 (8.33%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract congestion
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 24 (0.00%)
    2 / 22 (9.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric decompensation
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 24 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Blood glucose increased
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 24 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardio-respiratory arrest
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebellar infarction
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 24 (4.17%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 24 (4.17%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Essential tremor
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 24 (4.17%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 24 (4.17%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 24 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 24 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Anal fissure
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 24 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 24 (4.17%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Proctalgia
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 24 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 24 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Toxic skin eruption
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 24 (4.17%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc disorder
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 24 (4.17%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tendonitis
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 24 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Lung infection
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 24 (4.17%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 24 (0.00%)
    2 / 22 (9.09%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia streptococcal
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 24 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus inadequate control
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 24 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Failure to thrive
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 24 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 24 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 24 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 DLBCL Cohort FL Cohort MCL Cohort
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 26 (96.15%)
    23 / 24 (95.83%)
    22 / 22 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer pain
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 24 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 24 (0.00%)
    4 / 22 (18.18%)
         occurrences all number
    0
    0
    4
    Jugular vein thrombosis
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 24 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    2
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    3 / 26 (11.54%)
    4 / 24 (16.67%)
    5 / 22 (22.73%)
         occurrences all number
    4
    4
    6
    Face oedema
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 24 (8.33%)
    0 / 22 (0.00%)
         occurrences all number
    0
    3
    0
    Fatigue
         subjects affected / exposed
    6 / 26 (23.08%)
    13 / 24 (54.17%)
    8 / 22 (36.36%)
         occurrences all number
    7
    27
    11
    Oedema peripheral
         subjects affected / exposed
    0 / 26 (0.00%)
    3 / 24 (12.50%)
    0 / 22 (0.00%)
         occurrences all number
    0
    4
    0
    Pyrexia
         subjects affected / exposed
    3 / 26 (11.54%)
    1 / 24 (4.17%)
    2 / 22 (9.09%)
         occurrences all number
    4
    2
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 26 (7.69%)
    4 / 24 (16.67%)
    4 / 22 (18.18%)
         occurrences all number
    2
    4
    4
    Dyspnoea
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 24 (8.33%)
    2 / 22 (9.09%)
         occurrences all number
    2
    3
    3
    Pleural effusion
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 24 (8.33%)
    1 / 22 (4.55%)
         occurrences all number
    0
    2
    1
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 24 (4.17%)
    3 / 22 (13.64%)
         occurrences all number
    1
    1
    3
    Anxiety
         subjects affected / exposed
    6 / 26 (23.08%)
    5 / 24 (20.83%)
    7 / 22 (31.82%)
         occurrences all number
    6
    7
    11
    Confusional state
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 24 (4.17%)
    2 / 22 (9.09%)
         occurrences all number
    0
    1
    2
    Depression
         subjects affected / exposed
    8 / 26 (30.77%)
    6 / 24 (25.00%)
    7 / 22 (31.82%)
         occurrences all number
    8
    9
    8
    Insomnia
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 24 (4.17%)
    2 / 22 (9.09%)
         occurrences all number
    2
    1
    2
    Investigations
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 24 (4.17%)
    0 / 22 (0.00%)
         occurrences all number
    2
    1
    0
    Weight decreased
         subjects affected / exposed
    3 / 26 (11.54%)
    4 / 24 (16.67%)
    8 / 22 (36.36%)
         occurrences all number
    3
    5
    8
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 26 (3.85%)
    2 / 24 (8.33%)
    1 / 22 (4.55%)
         occurrences all number
    1
    2
    1
    Dysgeusia
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 24 (8.33%)
    0 / 22 (0.00%)
         occurrences all number
    0
    2
    0
    Headache
         subjects affected / exposed
    0 / 26 (0.00%)
    5 / 24 (20.83%)
    1 / 22 (4.55%)
         occurrences all number
    0
    5
    1
    Memory impairment
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 24 (4.17%)
    2 / 22 (9.09%)
         occurrences all number
    0
    1
    2
    Neuropathy peripheral
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 24 (4.17%)
    2 / 22 (9.09%)
         occurrences all number
    0
    1
    2
    Tremor
         subjects affected / exposed
    1 / 26 (3.85%)
    2 / 24 (8.33%)
    4 / 22 (18.18%)
         occurrences all number
    1
    3
    7
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 26 (3.85%)
    2 / 24 (8.33%)
    3 / 22 (13.64%)
         occurrences all number
    1
    3
    3
    Leukopenia
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 24 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    1
    0
    2
    Neutropenia
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 24 (4.17%)
    1 / 22 (4.55%)
         occurrences all number
    4
    1
    1
    Thrombocytopenia
         subjects affected / exposed
    1 / 26 (3.85%)
    2 / 24 (8.33%)
    1 / 22 (4.55%)
         occurrences all number
    1
    2
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 24 (8.33%)
    3 / 22 (13.64%)
         occurrences all number
    0
    3
    3
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 24 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    3
    Dry eye
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 24 (8.33%)
    0 / 22 (0.00%)
         occurrences all number
    0
    2
    0
    Vision blurred
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 24 (8.33%)
    1 / 22 (4.55%)
         occurrences all number
    0
    2
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    4 / 26 (15.38%)
    1 / 24 (4.17%)
    3 / 22 (13.64%)
         occurrences all number
    4
    1
    3
    Constipation
         subjects affected / exposed
    3 / 26 (11.54%)
    3 / 24 (12.50%)
    5 / 22 (22.73%)
         occurrences all number
    3
    3
    5
    Diarrhoea
         subjects affected / exposed
    5 / 26 (19.23%)
    9 / 24 (37.50%)
    6 / 22 (27.27%)
         occurrences all number
    10
    12
    8
    Dyspepsia
         subjects affected / exposed
    2 / 26 (7.69%)
    4 / 24 (16.67%)
    2 / 22 (9.09%)
         occurrences all number
    3
    5
    3
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 24 (8.33%)
    1 / 22 (4.55%)
         occurrences all number
    0
    3
    1
    Nausea
         subjects affected / exposed
    8 / 26 (30.77%)
    10 / 24 (41.67%)
    6 / 22 (27.27%)
         occurrences all number
    8
    17
    6
    Vomiting
         subjects affected / exposed
    3 / 26 (11.54%)
    3 / 24 (12.50%)
    0 / 22 (0.00%)
         occurrences all number
    5
    3
    0
    Hepatobiliary disorders
    Hepatotoxicity
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 24 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    2
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    0 / 26 (0.00%)
    3 / 24 (12.50%)
    1 / 22 (4.55%)
         occurrences all number
    0
    3
    1
    Pruritus
         subjects affected / exposed
    2 / 26 (7.69%)
    3 / 24 (12.50%)
    3 / 22 (13.64%)
         occurrences all number
    2
    3
    3
    Rash
         subjects affected / exposed
    2 / 26 (7.69%)
    4 / 24 (16.67%)
    3 / 22 (13.64%)
         occurrences all number
    2
    9
    3
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 26 (0.00%)
    3 / 24 (12.50%)
    2 / 22 (9.09%)
         occurrences all number
    0
    3
    2
    Muscle spasms
         subjects affected / exposed
    0 / 26 (0.00%)
    3 / 24 (12.50%)
    2 / 22 (9.09%)
         occurrences all number
    0
    4
    2
    Myalgia
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 24 (8.33%)
    0 / 22 (0.00%)
         occurrences all number
    0
    3
    0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 24 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    1
    0
    2
    Herpes zoster
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 24 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    2
    Pneumonia
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 24 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    2
    Urinary tract infection
         subjects affected / exposed
    2 / 26 (7.69%)
    3 / 24 (12.50%)
    1 / 22 (4.55%)
         occurrences all number
    2
    5
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 26 (7.69%)
    7 / 24 (29.17%)
    7 / 22 (31.82%)
         occurrences all number
    2
    8
    7
    Diabetes mellitus
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 24 (8.33%)
    0 / 22 (0.00%)
         occurrences all number
    0
    2
    0
    Hyperglycaemia
         subjects affected / exposed
    10 / 26 (38.46%)
    6 / 24 (25.00%)
    10 / 22 (45.45%)
         occurrences all number
    13
    8
    15
    Hypokalaemia
         subjects affected / exposed
    3 / 26 (11.54%)
    1 / 24 (4.17%)
    0 / 22 (0.00%)
         occurrences all number
    3
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Oct 2012
    The primary purpose for amending the protocol was to include monitoring for evidence of tumor lysis syndrome (TLS) during treatment with buparlisib. TLS might occur during treatment for diffuse large B-cell lymphoma; therefore the protocol and visit schedule were amended to include appropriate monitoring for evidence of TLS during the first 72 hours of study treatment. The requirement for not allowing previous treatment with mTOR inhibitors was removed from the exclusion criteria. Removing this exclusion broadened eligibility for this population that has a significant unmet medical need and potentially no anticipated impact on study results.
    10 Jan 2014
    The main purpose of this amendment was to update and align the management of selected AEs across the buparlisib program and with the Investigator’s Brochure version 6, specifically psychiatric disorders, hyperglycemia grade 2, skin rash and stomatitis. In addition to account for over enrollment, the number of subjects to be enrolled was capped to N=28 for all three cohorts.
    05 Aug 2015
    The main purpose of this protocol amendment was to provide additional guidance to Investigators around management of liver toxicities.
    09 Aug 2016
    The main purpose of this protocol amendment was to provide a clarification on the measures to follow when a subject exhibited suicidal ideation regardless of the response to question 9 of the PHQ-9 questionnaire. Patient Health Questionnaire-9 (PHQ-9) was used to increase the sensitivity of identifying potential depression and suicidal thoughts.

    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.
    Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com/CtrdWeb/home.nov for complete trial results.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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