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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of IPI-145 in Combination with Rituximab vs Rituximab in Subjects with Previously-Treated Follicular Lymphoma

    Summary
    EudraCT number
    2013-002406-31
    Trial protocol
    IT   GB   HU   ES   BE   AT   PL   DE   DK  
    Global end of trial date
    05 Oct 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    19 Oct 2017
    First version publication date
    19 Oct 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IPI-145-08
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    U1111-1158-1596
    Other trial identifiers
    IND Number: 112,486
    Sponsors
    Sponsor organisation name
    Infinity Pharmaceuticals, Inc.
    Sponsor organisation address
    780 Memorial Drive, Cambridge, MA, United States, 02139
    Public contact
    Brenda Jeglinski, Verastem, Inc., 001 781 292 4200, bjeglinski@verastem.com
    Scientific contact
    Brenda Jeglinski, Verastem, Inc., 001 781 292 4200, bjeglinski@verastem.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
    21 Dec 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Oct 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    to evaluate the efficacy of duvelisib (IPI-145) administered in combination with rituximab (D+R) vs placebo in combination with rituximab (PBO+R) in subjects with previously-treated CD20-positive follicular lymphoma (FL)
    Protection of trial subjects
    Prior to screening for enrollment into the clinical trial, all patients were provided detailed information about the investigational product and the trial. During the informed consent process, patients were allowed to ask questions and have a conversation with the study staff providing consent. The informed consent form (ICF) included all elements required by ICH, GCP, and adhered to the IRB/IEC requirements and the ethical principles that have their origin in the Declaration of Helsinki. It was explained to patients during this conversation that they have the right to withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. The ICF was updated when important new information became available, and all patients still receiving treatment in the trial were re-consented on the new information. During the trial, protection of trial subjects took the form of adverse event and concomitant medication monitoring, and disease response monitoring. Adverse events (AEs) were monitored from the time of signing the ICF. The Protocol provided information on what concomitant medication and therapies were either not allowed or should be used with caution. An assessment of these medications and therapies was performed at every clinic visit. Lastly, disease response assessments were performed according to the scheduled stipulated in the Protocol. If a study subject progressed, appropriate conversations were had with their study investigator to determine the best course of action for further treatment or management of their disease, outside of the clinical trial.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    17 Mar 2015
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Efficacy
    Long term follow-up duration
    7 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 3
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Italy: 3
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    United States: 2
    Country: Number of subjects enrolled
    Australia: 1
    Worldwide total number of subjects
    13
    EEA total number of subjects
    9
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    6
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Screening will be performed ≤30 days from randomization.

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Duvelisib 25 mg BID and Rituximab
    Arm description
    IPI-145 (25 mg BID) administered orally in 28-day continuous treatment cycles + IV infusion of rituximab (375 mg/m2) once weekly for 4 weeks during Cycle 1, then once on Day 1 of Cycles 4, 6, 8, and 10.
    Arm type
    Experimental

    Investigational medicinal product name
    Duvelisib
    Investigational medicinal product code
    IPI-145
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    The blinded study drug should be swallowed whole with a glass of water (approximately 8 ounces or 240 mL) at approximately the same time(s) each day.

    Investigational medicinal product name
    Rituximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Rituximab will be administered via infusion. Premedication consisting of an anti-pyretic and an antihistaminic should always be administered before each infusion of rituximab. Premedication with glucocorticoids should also be considered.

    Arm title
    Placebo and Rituximab
    Arm description
    Matching Placebo administered orally in 28-day continuous treatment cycles + IV infusion of rituximab (375 mg/m2) once weekly for 4 weeks during Cycle 1, then once on Day 1 of Cycles 4, 6, 8, and 10.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    The blinded study drug should be swallowed whole with a glass of water (approximately 8 ounces or 240 mL) at approximately the same time(s) each day.

    Investigational medicinal product name
    Rituximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Rituximab will be administered via infusion. Premedication consisting of an anti-pyretic and an antihistaminic should always be administered before each infusion of rituximab. Premedication with glucocorticoids should also be considered.

    Number of subjects in period 1
    Duvelisib 25 mg BID and Rituximab Placebo and Rituximab
    Started
    6
    7
    Completed
    2
    0
    Not completed
    4
    7
         IP discontinuation due to SAE
    1
    -
         Termination of Study by Sponsor
    2
    6
         Patient progression disease
    -
    1
         Patient deemed ineligible
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Duvelisib 25 mg BID and Rituximab
    Reporting group description
    IPI-145 (25 mg BID) administered orally in 28-day continuous treatment cycles + IV infusion of rituximab (375 mg/m2) once weekly for 4 weeks during Cycle 1, then once on Day 1 of Cycles 4, 6, 8, and 10.

    Reporting group title
    Placebo and Rituximab
    Reporting group description
    Matching Placebo administered orally in 28-day continuous treatment cycles + IV infusion of rituximab (375 mg/m2) once weekly for 4 weeks during Cycle 1, then once on Day 1 of Cycles 4, 6, 8, and 10.

    Reporting group values
    Duvelisib 25 mg BID and Rituximab Placebo and Rituximab Total
    Number of subjects
    6 7 13
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    4 2 6
        From 65-84 years
    2 5 7
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    62.7 (50 to 81) 65.4 (42 to 79) -
    Gender categorical
    Units: Subjects
        Female
    4 1 5
        Male
    2 6 8

    End points

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    End points reporting groups
    Reporting group title
    Duvelisib 25 mg BID and Rituximab
    Reporting group description
    IPI-145 (25 mg BID) administered orally in 28-day continuous treatment cycles + IV infusion of rituximab (375 mg/m2) once weekly for 4 weeks during Cycle 1, then once on Day 1 of Cycles 4, 6, 8, and 10.

    Reporting group title
    Placebo and Rituximab
    Reporting group description
    Matching Placebo administered orally in 28-day continuous treatment cycles + IV infusion of rituximab (375 mg/m2) once weekly for 4 weeks during Cycle 1, then once on Day 1 of Cycles 4, 6, 8, and 10.

    Primary: Death due to any cause

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    End point title
    Death due to any cause [1]
    End point description
    End point type
    Primary
    End point timeframe
    Throughout the study
    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: Due to the small number of evaluable subjects, the pre-planned analyses supporting the endpoints were not amenable to analyses.
    End point values
    Duvelisib 25 mg BID and Rituximab Placebo and Rituximab
    Number of subjects analysed
    6
    7
    Units: Number of subjects
    0
    0
    No statistical analyses for this end point

    Secondary: Best Overall Response Rate (ORR) - Partial response (PR)

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    End point title
    Best Overall Response Rate (ORR) - Partial response (PR)
    End point description
    ORR was performed based on investigator analyses
    End point type
    Secondary
    End point timeframe
    Throughout the study
    End point values
    Duvelisib 25 mg BID and Rituximab Placebo and Rituximab
    Number of subjects analysed
    5
    6
    Units: Number of subjects
    2
    1
    No statistical analyses for this end point

    Secondary: Best Overall Response Rate (ORR) - Complete response (CR)

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    End point title
    Best Overall Response Rate (ORR) - Complete response (CR)
    End point description
    ORR was performed based on investigator analyses
    End point type
    Secondary
    End point timeframe
    Throughout the study
    End point values
    Duvelisib 25 mg BID and Rituximab Placebo and Rituximab
    Number of subjects analysed
    5
    6
    Units: Number of subjects
    3
    0
    No statistical analyses for this end point

    Secondary: Best Overall Response Rate (ORR) - Stable disease (SD)

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    End point title
    Best Overall Response Rate (ORR) - Stable disease (SD)
    End point description
    ORR was performed based on investigator analyses
    End point type
    Secondary
    End point timeframe
    Throughout the study
    End point values
    Duvelisib 25 mg BID and Rituximab Placebo and Rituximab
    Number of subjects analysed
    5
    6
    Units: Number of subjects
    0
    3
    No statistical analyses for this end point

    Secondary: Best Overall Response Rate (ORR) - Progressive disease (PD)

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    End point title
    Best Overall Response Rate (ORR) - Progressive disease (PD)
    End point description
    ORR was performed based on investigator analyses
    End point type
    Secondary
    End point timeframe
    Throughout the study
    End point values
    Duvelisib 25 mg BID and Rituximab Placebo and Rituximab
    Number of subjects analysed
    5
    6
    Units: Number of subjects
    0
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    For randomized subjects, AEs will be collected on the eCRF from signing of the ICF through 30 days after the final dose of either the blinded study drug or rituximab (whichever is later).
    Adverse event reporting additional description
    The SAEs and AEs have been recorded until the data base lock. At this time, there were 2 subjects remaining on study. The SAEs covering the time from the data cut to the date of the last subject last visit in this study are included here as well.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Duvelisib 25 mg BID and Rituximab
    Reporting group description
    IPI-145 (25 mg BID) administered orally in 28-day continuous treatment cycles + IV infusion of rituximab (375 mg/m2) once weekly for 4 weeks during Cycle 1, then once on Day 1 of Cycles 4, 6, 8, and 10.

    Reporting group title
    Placebo and Rituximab
    Reporting group description
    Matching Placebo administered orally in 28-day continuous treatment cycles + IV infusion of rituximab (375 mg/m2) once weekly for 4 weeks during Cycle 1, then once on Day 1 of Cycles 4, 6, 8, and 10.

    Serious adverse events
    Duvelisib 25 mg BID and Rituximab Placebo and Rituximab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 6 (83.33%)
    0 / 7 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Respiratory, thoracic and mediastinal disorders
    Interstitial lung disease
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    10 / 13
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    10 / 13
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    10 / 13
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    10 / 13
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    10 / 13
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal inflammation
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    10 / 13
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    3 / 6 (50.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    10 / 13
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia cytomegaloviral
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    10 / 13
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    Duvelisib 25 mg BID and Rituximab Placebo and Rituximab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 6 (100.00%)
    7 / 7 (100.00%)
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 6 (33.33%)
    2 / 7 (28.57%)
         occurrences all number
    6
    7
    Chest pain
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    6
    7
    Oedema peripheral
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 7 (14.29%)
         occurrences all number
    6
    7
    Pyrexia
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 7 (14.29%)
         occurrences all number
    6
    7
    Chills
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 7 (28.57%)
         occurrences all number
    6
    7
    Fatigue
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 7 (28.57%)
         occurrences all number
    6
    7
    Influenza like illness
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    6
    7
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 7 (28.57%)
         occurrences all number
    6
    7
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 7 (28.57%)
         occurrences all number
    6
    7
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    3 / 6 (50.00%)
    0 / 7 (0.00%)
         occurrences all number
    6
    7
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 6 (50.00%)
    0 / 7 (0.00%)
         occurrences all number
    6
    7
    Amylase increased
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    6
    7
    Blood cholesterol increased
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    6
    7
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    6
    7
    Lipase increased
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    6
    7
    Weight decreased
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    6
    7
    Blood uric acid increased
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    6
    7
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 7 (0.00%)
         occurrences all number
    6
    7
    Respiratory, thoracic and mediastinal disorders
    Interstitial lung disease
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 7 (0.00%)
         occurrences all number
    6
    7
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    6
    7
    Cough
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    6
    7
    Dyspnoea
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    6
    7
    Hypoventilation
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    6
    7
    Pneumonitis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    6
    7
    Respiratory failure
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    6
    7
    Productive cough
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    6
    7
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    6
    7
    Hypoaesthesia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    6
    7
    Balance disorder
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    6
    7
    Sciatica
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    6
    7
    Eye disorders
    Vision blurred
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    6
    7
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 7 (14.29%)
         occurrences all number
    6
    7
    Abdominal pain upper
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    6
    7
    Constipation
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    6
    7
    Dysphagia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    6
    7
    Gastrointestinal inflammation
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    6
    7
    Mouth ulceration
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    6
    7
    Nausea
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    6
    7
    Abdominal distension
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    6
    7
    Dry mouth
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    6
    7
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    6
    7
    Pruritus
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    6
    7
    Skin discolouration
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    6
    7
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    6
    7
    Metatarsalgia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    6
    7
    Muscle spasms
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    6
    7
    Pain in extremity
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    6
    7
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    6
    7
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    6
    7
    Hyperuricaemia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    6
    7
    Hypokalaemia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    6
    7
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 7 (0.00%)
         occurrences all number
    6
    7
    Gastroenteritis
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 7 (14.29%)
         occurrences all number
    6
    7
    Pneumonia cytomegaloviral
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    6
    7
    Bronchitis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    6
    7
    Bronchitis viral
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    6
    7
    Nasopharyngitis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    6
    7
    Oral herpes
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    6
    7
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    6
    7

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    05 Oct 2016
    This study was terminated early due to enrolment challenges. Two patients in Italy remained on study at the time of the data cut (05 October 2016) and were rolled over into the extension study IPI-145-23. The Last Subject Last Visit (LSLV) date for this trial was 03 March 2017. Due to the small number of evaluable subjects, many of the endpoints were not amenable to analyses. Only ORR and the safety analyses are available for this report.
    -

    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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