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    Clinical Trial Results:
    A Phase 2, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of IPI-926 in Patients with Metastatic or Locally Advanced (Unresectable) Chondrosarcoma

    Summary
    EudraCT number
    		 2010-024518-74
    Trial protocol
    		 GB   SE   DE   NO   NL   AT   IT   ES  
    Global end of trial date
    15 Oct 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Jul 2016
    First version publication date
    09 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IPI-926-04
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND number: 78,428
    Sponsors
    Sponsor organisation name
    Infinity Pharmaceuticals, Inc.
    Sponsor organisation address
    780 Memorial Drive , Cambridge, MA, United States, 02139
    Public contact
    IPI-926-04 Trial Information, Infinity Pharmaceuticals, Inc., +1 617 453 1000,
    Scientific contact
    David A. Roth, MD, Infinity Pharmaceuticals, Inc., +1 617 453 1412,
    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
    Interim
    Date of interim/final analysis
    12 Nov 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Oct 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Oct 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    - Compare progression-free survival (PFS) in patients with metastatic or locally advanced (unresectable) chondrosarcoma administered IPI-926 or placebo. - Evaluate the safety of IPI-926 in patients with metastatic or locally advanced(unresectable) chondrosarcoma
    Protection of trial subjects
    Independent Data Monitoring Committee initiated for IPI-145-04. Agroup of individuals with pertinent expertise that regularly reviews accumulating data from an ongoing clinical study. The iDMC advises the Sponsor regarding the continuing safety of trial subjects, as well as the continuing validity and scientific merit of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Jun 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 3 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 4
    Country: Number of subjects enrolled
    Norway: 2
    Country: Number of subjects enrolled
    Poland: 4
    Country: Number of subjects enrolled
    Sweden: 6
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    Austria: 1
    Country: Number of subjects enrolled
    France: 6
    Country: Number of subjects enrolled
    Germany: 20
    Country: Number of subjects enrolled
    Italy: 10
    Country: Number of subjects enrolled
    Canada: 3
    Country: Number of subjects enrolled
    Russian Federation: 3
    Country: Number of subjects enrolled
    United States: 38
    Country: Number of subjects enrolled
    Australia: 2
    Worldwide total number of subjects
    105
    EEA total number of subjects
    59
    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)
    82
    From 65 to 84 years
    23
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 152 [1]
    Number of subjects completed
    		 105

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Screening failure: 47
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The number of screened patients (152) per country and per age group has been collected but has not been prespecified in the Statistical Analysis Plan. Therefore, the number of randomized patients (105) per country and per age group is indicated in the Trial information section.
    Period 1
    Period 1 title
    Double-blind (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 IPI-926
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    IPI-926
    Investigational medicinal product code
    PR1
    Other name
    2',3a,3',4,4',4a',5,5',6,6',6a',6b',7,7a,7',8',10',12',12a',12b'-icosahydro-1'H,3Hspiro[furo[3,2-b]pyridine-2,9'-naphtho[2,1-a]azulene]-3'-yl)methanesulfonamide
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    IPI-926 will be administered at a dose of 160 mg/day, as one dose per day.

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    PL1
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Doses of placebo are to be taken as one dose per day.

    Number of subjects in period 1
    		IPI-926 Placebo
    Started
    71
    34
    Completed
    0
    0
    Not completed
    71
    34
         RECIST confirmed Disease Progression
    37
    19
         Study termination by Sponsor
    13
    -
         Terminated by Sponsor
    -
    8
         Physician decision
    1
    -
         Consent withdrawn by subject
    1
    1
         'Clinical disease progression '
    8
    -
         Other
    7
    1
         Adverse event
    4
    2
         Clinical or symptomatic disease progression
    -
    2
         'Non-compliance with study drug '
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Double-blind
    Reporting group description
    		 For each cycle during the double-blind portion of the study, 160 mg oral IPI-926 or placebo was administered daily for 28 days. For the 71 subjects treated with IPI-926 in the double-blind phase, the median (range) duration of exposure was 10.1 (2 to 52.6) weeks. The median (range) total dose of IPI-926 received was 11360 (2240 to 49100) mg.

    Reporting group values
    		 Double-blind Total
    Number of subjects
    		 105 105
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 82 82
        From 65-84 years
    		 23 23
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 52.8 (24 to 82) -
    Gender categorical
    Units: Subjects
        Female
    		 31 31
        Male
    		 74 74
    Subject analysis sets

    Subject analysis set title
    IPI-926
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis set (FAS) includes all randomized patients in the treatment group assigned by randomization. The FAS is used for all efficacy analyses. The principle of an intent-to-treat analysis will be used to define the FAS population.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis set (FAS) includes all randomized patients in the treatment group assigned by randomization. The FAS is used for all efficacy analyses. The principle of an intent-to-treat analysis will be used to define the FAS population.

    Subject analysis sets values
    		 IPI-926 Placebo
    Number of subjects
    71
    34
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    53
    29
        From 65-84 years
    18
    5
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    53.7 (24 to 82)
    50.9 (25 to 70)
    Gender categorical
    Units: Subjects
        Female
    20
    11
        Male
    51
    23

    End points

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    End points reporting groups
    Reporting group title
    IPI-926
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Subject analysis set title
    IPI-926
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis set (FAS) includes all randomized patients in the treatment group assigned by randomization. The FAS is used for all efficacy analyses. The principle of an intent-to-treat analysis will be used to define the FAS population.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis set (FAS) includes all randomized patients in the treatment group assigned by randomization. The FAS is used for all efficacy analyses. The principle of an intent-to-treat analysis will be used to define the FAS population.

    Primary: PFS

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    End point title
    		 PFS
    End point description
    End point type
    Primary
    End point timeframe
    CT scan or MRI on Day 27 (± 2 days) of Cycles 1, 2, 4, 6, and 8, and every third cycle thereafter on Day 27 (±2 days), as well as at the end of treatment.
    End point values
    		 IPI-926 Placebo IPI-926 Placebo
    Number of subjects analysed
    71
    34
    71
    34
    Units: months
        number (confidence interval 95%)
    3.7 (1.87 to 3.71)
    2.9 (1.84 to 4.04)
    3.7 (1.87 to 3.71)
    2.9 (1.84 to 4.04)
    Statistical analysis title
    		 Kaplan Meyer estimate
    Comparison groups
    IPI-926 v Placebo
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.792
    Method
    		 Logrank
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All AEs were recorded from the time of informed consent until 30 days after the last dose of study treatment.
    Adverse event reporting additional description
    Patients were instructed to report all AEs and were asked a general health status question at each study visit. All adverse events, whether volunteered or elicited, were recorded on the eCRF. An adverse event was followed until it was either resolved, had returned to baseline, or was determined to be a stable or chronic condition.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    IPI-926
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 IPI-926 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    22 / 71 (30.99%)
    8 / 34 (23.53%)
         number of deaths (all causes)
    5
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases to neck
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastasis
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour pain
         subjects affected / exposed
    1 / 71 (1.41%)
    2 / 34 (5.88%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Periprosthetic fracture
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Lymphoedema
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Spinal cord compression
         subjects affected / exposed
    2 / 71 (2.82%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraparesis
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Disease progression
         subjects affected / exposed
    3 / 71 (4.23%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 8
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Enterocutaneous fistula
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    2 / 71 (2.82%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    2 / 71 (2.82%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory arrest
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary hesitation
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pathological fracture
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    2 / 71 (2.82%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 IPI-926 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    67 / 71 (94.37%)
    29 / 34 (85.29%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    28 / 71 (39.44%)
    0 / 34 (0.00%)
         occurrences all number
    67
    29
    Aspartate aminotransferase increased
         subjects affected / exposed
    22 / 71 (30.99%)
    0 / 34 (0.00%)
         occurrences all number
    67
    29
    Blood alkaline phosphatase increased
         subjects affected / exposed
    12 / 71 (16.90%)
    1 / 34 (2.94%)
         occurrences all number
    67
    29
    Blood bilirubin increased
         subjects affected / exposed
    5 / 71 (7.04%)
    0 / 34 (0.00%)
         occurrences all number
    67
    29
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    8 / 71 (11.27%)
    0 / 34 (0.00%)
         occurrences all number
    67
    29
    Headache
         subjects affected / exposed
    6 / 71 (8.45%)
    1 / 34 (2.94%)
         occurrences all number
    67
    29
    Dizziness
         subjects affected / exposed
    5 / 71 (7.04%)
    0 / 34 (0.00%)
         occurrences all number
    67
    29
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    21 / 71 (29.58%)
    2 / 34 (5.88%)
         occurrences all number
    67
    29
    Constipation
         subjects affected / exposed
    21 / 71 (29.58%)
    2 / 34 (5.88%)
         occurrences all number
    67
    29
    Vomiting
         subjects affected / exposed
    11 / 71 (15.49%)
    2 / 34 (5.88%)
         occurrences all number
    67
    29
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    9 / 71 (12.68%)
    2 / 34 (5.88%)
         occurrences all number
    67
    29
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    6 / 71 (8.45%)
    0 / 34 (0.00%)
         occurrences all number
    67
    29
    Rash
         subjects affected / exposed
    4 / 71 (5.63%)
    0 / 34 (0.00%)
         occurrences all number
    67
    29
    Musculoskeletal and connective tissue disorders
    Muscle spasms
         subjects affected / exposed
    12 / 71 (16.90%)
    4 / 34 (11.76%)
         occurrences all number
    67
    29
    Back pain
         subjects affected / exposed
    4 / 71 (5.63%)
    0 / 34 (0.00%)
         occurrences all number
    67
    29
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    4 / 71 (5.63%)
    0 / 34 (0.00%)
         occurrences all number
    67
    29
    Nasopharyngitis
         subjects affected / exposed
    1 / 71 (1.41%)
    3 / 34 (8.82%)
         occurrences all number
    67
    29
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 71 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    67
    29
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    14 / 71 (19.72%)
    3 / 34 (8.82%)
         occurrences all number
    67
    29

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Jan 2011
    Protocol Amendment 1
    07 Apr 2011
    IMPD Amendment
    19 Apr 2011
    IB Edition 04
    19 Aug 2011
    IB Edition 05
    07 Sep 2011
    Protocol Amendment 2
    09 Sep 2011
    IMPD Amendment
    23 Dec 2011
    IMPD Amendment
    27 Mar 2012
    Protocol Amendment 3
    27 Mar 2012
    IB Edition 06

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    18 Jun 2012
    On 14 June 2012, a planned futility analysis of data from the study concluded that treatment with IPI-926 was similar to placebo and, therefore, the trial would not meet its primary endpoint. Based on this interim analysis, Infinity announced on 18 June 2012 it was stopping the trial. No formal efficacy or exploratory analyses were performed.
    -

    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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