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    Clinical Trial Results:
    A multicentre, open-label, three-arm randomised Phase II trial assessing the safety and efficacy of the HSP90 inhibitor Ganetespib in combination with Carboplatin followed by maintenance treatment with Niraparib versus Ganetespib plus Carboplatin followed by Ganetespib and Niraparib versus Carboplatin in combination with standard chemotherapy followed by Niraparib maintenance treatment in platinum-sensitive ovarian cancer patients

    Summary
    EudraCT number
    		 2017-004058-40
    Trial protocol
    		 BE   DE   FR   AT   IT  
    Global end of trial date
    01 Sep 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Jun 2024
    First version publication date
    22 Jun 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EUDARIO
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03783949
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    BGOG-KULeuven
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium, 3000
    Public contact
    Joke De Roover, Katholieke Universiteit Leuven, 32 16347419, bgog@engot.eu
    Scientific contact
    Joke De Roover, Katholieke Universiteit Leuven, 32 16347419, bgog@engot.eu
    Sponsor organisation name
    BGOG-KULeuven
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium, 3000
    Public contact
    Ellen Reynders, BGOG-KULeuven, 32 16342996, ellen.reynders@uzleuven.be
    Scientific contact
    Prof. Nicole Concin, IMU Innsbruck, 43 51250481433, nicole.concin@i-med.ac.at
    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
    25 Sep 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Sep 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Sep 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the progression-free survival (PFS) by RECIST 1.1
    Protection of trial subjects
    Approval for the trial was obtained from the EC and CA. Trial was performed according to the ICH-GCP guidelines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Nov 2018
    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
    Austria: 4
    Country: Number of subjects enrolled
    Belgium: 33
    Country: Number of subjects enrolled
    France: 17
    Country: Number of subjects enrolled
    Germany: 17
    Country: Number of subjects enrolled
    Italy: 51
    Worldwide total number of subjects
    122
    EEA total number of subjects
    122
    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)
    68
    From 65 to 84 years
    54
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients with platinum-sensitive measurable or evaluable ovarian cancer were included. Borderline tumors, increased risk for gastrointestinal perforation or history of myelodysplastic syndome or acute myeloid leukemia were excluded

    Pre-assignment
    Screening details
    		 Patients underwent the screening examinations as per protocol. No pre-screening assessments were performed in the scope of the trial

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    study was not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A
    Arm description
    		 Carboplatin + Paclitaxel or Gemcitabin followed by Niraparib maintenance treatment
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    AUC5 d1 q3w IV (6 doses)

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    175mg/m² D1 q3w IV for 6 cycles

    Investigational medicinal product name
    Niraparib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Oral use
    Dosage and administration details
    200-300mg QD PO

    Arm title
    		 Arm B
    Arm description
    		 Carboplatin + Ganetspib followed by Niraparib maintenance
    Arm type
    		 Experimental

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    AUC5 d1 q3w for 6 cycles

    Investigational medicinal product name
    Ganetespib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    150mg/m² D1 q3w for 6 cycles

    Investigational medicinal product name
    Niraparib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200/300 mg daily

    Arm title
    		 Arm C
    Arm description
    		 Carboplatin + Ganetespib followed by Ganetespib + Niraparib maintenance
    Arm type
    		 Experimental

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    AUC5 d1 q3w IV (6 doses)

    Investigational medicinal product name
    Ganetespib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    150mg/m² D1 q3w for 6 cycles

    Investigational medicinal product name
    Ganetespib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    100mg/m² D1 qw (during maintenance treatment)

    Investigational medicinal product name
    Niraparib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200mg daily

    Number of subjects in period 1
    		Arm A Arm B Arm C
    Started
    41
    42
    39
    Start of maintenance treatment
    32
    27
    17
    Completed
    2
    0
    2
    Not completed
    39
    42
    37
         Adverse event, serious fatal
    1
    1
    -
         Consent withdrawn by subject
    1
    1
    5
         Adverse event, non-fatal
    1
    5
    5
         Lack of efficacy
    36
    35
    27

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 Carboplatin + Paclitaxel or Gemcitabin followed by Niraparib maintenance treatment

    Reporting group title
    Arm B
    Reporting group description
    		 Carboplatin + Ganetspib followed by Niraparib maintenance

    Reporting group title
    Arm C
    Reporting group description
    		 Carboplatin + Ganetespib followed by Ganetespib + Niraparib maintenance

    Reporting group values
    		 Arm A Arm B Arm C Total
    Number of subjects
    		 41 42 39 122
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 21 25 22 68
        From 65-84 years
    		 20 17 17 54
    Gender categorical
    Units: Subjects
        Female
    		 41 42 39 122
        Male
    		 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 Carboplatin + Paclitaxel or Gemcitabin followed by Niraparib maintenance treatment

    Reporting group title
    Arm B
    Reporting group description
    		 Carboplatin + Ganetspib followed by Niraparib maintenance

    Reporting group title
    Arm C
    Reporting group description
    		 Carboplatin + Ganetespib followed by Ganetespib + Niraparib maintenance

    Primary: Progression free survival

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    End point title
    		 Progression free survival
    End point description
    Progression-free survival (PFS) by RECIST 1.1
    End point type
    Primary
    End point timeframe
    3 years 10 months
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    41
    41
    39
    Units: month
        median (confidence interval 95%)
    8.85 (7.73 to 11.5)
    8.32 (6.88 to 9.70)
    8.32 (6.88 to 9.70)
    Statistical analysis title
    		 Log-rank test
    Statistical analysis description
    the median time to progression was estimated using the Kaplan-Meier method and the 95% confidence interval of the median was reported. The restricted mean as a measure for PFS was calculated using the area under the survival curve (AUC) at the end of the study. In addition, Cox proportional hazards regression analysis adjusting for the stratification factors was applied. The same procedure was applied to exploratively compare the different treatment arm
    Comparison groups
    Arm A v Arm B v Arm C
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.5417
    Method
    		 Logrank
    Parameter type
    		 Median difference (net)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.88
         upper limit
    		 11.55
    Variability estimate
    Standard deviation

    Secondary: Progression-free Survival in BRCA Mutated Patients

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    End point title
    		 Progression-free Survival in BRCA Mutated Patients
    End point description
    Progression-free survival analysis in BRCA mutated patients
    End point type
    Secondary
    End point timeframe
    3 years 10 months
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    13
    12
    12
    Units: month
        median (confidence interval 95%)
    11.78 (7.30 to 17.37)
    7.98 (6.09 to 11.05)
    7.98 (6.09 to 11.02)
    No statistical analyses for this end point

    Secondary: Post-progression PFS (PFS2)

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    End point title
    		 Post-progression PFS (PFS2)
    End point description
    Post-progression PFS (PFS2) analysis
    End point type
    Secondary
    End point timeframe
    3 years 10 months
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    41
    40
    39
    Units: month
        median (confidence interval 95%)
    21.71 (17.73 to 25.30)
    21.38 (15.53 to 26.18)
    21.38 (15.53 to 26.18)
    No statistical analyses for this end point

    Secondary: Time to First Subsequent Therapy (TFST)

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    End point title
    		 Time to First Subsequent Therapy (TFST)
    End point description
    Time to First Subsequent Therapy (TFST) analysis
    End point type
    Secondary
    End point timeframe
    3 years 10 months
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    41
    41
    39
    Units: month
        median (confidence interval 95%)
    9.38 (8.09 to 12.47)
    8.75 (7.40 to 10.07)
    8.75 (7.40 to 10.07)
    No statistical analyses for this end point

    Secondary: Time to Second Subsequent Therapy (TSST)

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    End point title
    		 Time to Second Subsequent Therapy (TSST)
    End point description
    Time to Second Subsequent Therapy (TSST) analysis
    End point type
    Secondary
    End point timeframe
    3 years 10 months
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    41
    41
    39
    Units: month
        median (confidence interval 95%)
    17.73 (14.28 to 21.61)
    14.54 (13.26 to 16.94)
    14.54 (13.26 to 16.94)
    No statistical analyses for this end point

    Secondary: Progression-free Survival in Patients Without BRCA Mutation or With Unkown BRCA Status

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    End point title
    		 Progression-free Survival in Patients Without BRCA Mutation or With Unkown BRCA Status
    End point description
    Progression-free Survival analysis in Patients without BRCA mutation or with unkown BRCA status
    End point type
    Secondary
    End point timeframe
    3 years 10 months
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    28
    28
    28
    Units: month
        median (confidence interval 95%)
    7.83 (6.58 to 11.38)
    8.49 (6.71 to 10.49)
    8.49 (6.71 to 10.49)
    No statistical analyses for this end point

    Secondary: Objective Response Rate (ORR)

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    End point title
    		 Objective Response Rate (ORR)
    End point description
    Objective response rate (ORR) analysis
    End point type
    Secondary
    End point timeframe
    3 years 10 months
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    38
    40
    39
    Units: patients
        no response (SD/PD)
    21
    26
    26
        response (CR/PR)
    17
    13
    14
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    Overall survival (OS) analysis
    End point type
    Secondary
    End point timeframe
    3 years 10 months
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    41
    42
    39
    Units: month
        median (confidence interval 95%)
    22.14 (17.73 to 29.97)
    22.27 (17.07 to 29.21)
    22.27 (17.07 to 29.21)
    No statistical analyses for this end point

    Secondary: Progression-free Survival in Patients With Prior PARPi Treatment

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    End point title
    		 Progression-free Survival in Patients With Prior PARPi Treatment
    End point description
    Progression-free Survival analysis in Patients with prior PARPi treatment
    End point type
    Secondary
    End point timeframe
    3 years 10 months
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    13
    13
    12
    Units: month
        median (confidence interval 95%)
    7.40 (5.63 to 8.85)
    6.09 (2.76 to 7.76)
    6.09 (2.76 to 7.76)
    No statistical analyses for this end point

    Secondary: Progression-free Survival in Patients With One Prior Line of Therapy

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    End point title
    		 Progression-free Survival in Patients With One Prior Line of Therapy
    End point description
    Progression-free Survival analysis in Patients with one prior line of therapy
    End point type
    Secondary
    End point timeframe
    3 years 10 months
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    27
    23
    23
    Units: month
        median (confidence interval 95%)
    10.59 (5.92 to 11.94)
    9.70 (7.14 to 11.35)
    9.70 (7.14 to 11.35)
    No statistical analyses for this end point

    Secondary: Progression-free Survival in Patients With More Then One Prior Line of Therapy

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    End point title
    		 Progression-free Survival in Patients With More Then One Prior Line of Therapy
    End point description
    Progression-free Survival analysis in Patients with more then one prior line of therapy
    End point type
    Secondary
    End point timeframe
    3 years 10 months
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    14
    17
    17
    Units: month
        median (confidence interval 95%)
    7.63 (7.30 to 12.89)
    7.43 (4.11 to 8.32)
    7.43 (4.11 to 8.32)
    No statistical analyses for this end point

    Secondary: Progression-free Survival in Patients Without Prior PARPi Treatment

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    End point title
    		 Progression-free Survival in Patients Without Prior PARPi Treatment
    End point description
    Progression-free Survival analysis in Patients without prior PARPi treatment
    End point type
    Secondary
    End point timeframe
    3 years 10 months
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    27
    22
    23
    Units: month
        median (confidence interval 95%)
    11.55 (7.43 to 13.55)
    9.77 (7.83 to 11.12)
    9.77 (7.83 to 11.12)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    3 years 10 months
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 Carboplatin + Paclitaxel or Gemcitabin followed by Niraparib maintenance

    Reporting group title
    Arm B
    Reporting group description
    		 Carboplatin + Ganetespib followed by Niraparib maintenance

    Reporting group title
    Arm C
    Reporting group description
    		 Carboplatin + Ganetespib followed by Ganetspib + Niraparib maintenance

    Serious adverse events
    		 Arm A Arm B Arm C
    Total subjects affected by serious adverse events
         subjects affected / exposed
    23 / 41 (56.10%)
    19 / 42 (45.24%)
    16 / 39 (41.03%)
         number of deaths (all causes)
    23
    24
    23
         number of deaths resulting from adverse events
    1
    2
    1
    Investigations
    Bilirubin increased
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 42 (2.38%)
    0 / 39 (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
    Hypokalemia
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 42 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    10 / 41 (24.39%)
    0 / 42 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    8 / 10
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    5 / 41 (12.20%)
    1 / 42 (2.38%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    5 / 5
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tumor biopsy
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 42 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    transaminases increased
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 42 (2.38%)
    0 / 39 (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
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 42 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 42 (2.38%)
    0 / 39 (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
    Pericardial effusion
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 42 (0.00%)
    1 / 39 (2.56%)
         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
    abdominal pain
         subjects affected / exposed
    1 / 41 (2.44%)
    4 / 42 (9.52%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    1 / 1
    4 / 4
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    0 / 41 (0.00%)
    2 / 42 (4.76%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    dehydration
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 42 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    fever
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 42 (0.00%)
    0 / 39 (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
    fistula
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 42 (0.00%)
    1 / 39 (2.56%)
         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 malaise
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 42 (2.38%)
    0 / 39 (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
    headache
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 42 (2.38%)
    0 / 39 (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
    Syncope
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 42 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Systemic inflammatory response syndrome
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 42 (2.38%)
    0 / 39 (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
    Word finding disorder
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 42 (2.38%)
    0 / 39 (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 deterioration
         subjects affected / exposed
    2 / 41 (4.88%)
    1 / 42 (2.38%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Immune system disorders
    Allergic reaction to Carboplatin
         subjects affected / exposed
    1 / 41 (2.44%)
    3 / 42 (7.14%)
    3 / 39 (7.69%)
         occurrences causally related to treatment / all
    1 / 1
    3 / 3
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    allergic reaction NOS
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 42 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Intestinal obstruction
         subjects affected / exposed
    21 / 41 (51.22%)
    0 / 42 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 41 (0.00%)
    2 / 42 (4.76%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastro-entiritis
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 42 (2.38%)
    0 / 39 (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
    Gastrointestinal perforation
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 42 (2.38%)
    0 / 39 (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
    Ileus
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 42 (2.38%)
    0 / 39 (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
    intestinal subobstruction
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 42 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    rectal bleeding
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 42 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    stomach pain
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 42 (0.00%)
    0 / 39 (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
    subileus
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 42 (0.00%)
    0 / 39 (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
    vomiting
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 42 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 42 (0.00%)
    0 / 39 (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
    Respiratory, thoracic and mediastinal disorders
    Dyspnea
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 42 (2.38%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Maligne pleuritis
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 42 (2.38%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 42 (2.38%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 42 (2.38%)
    0 / 39 (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
    Pulmonary tuberculosis
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 42 (2.38%)
    0 / 39 (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
    pneumonia
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 42 (0.00%)
    0 / 39 (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
    Renal and urinary disorders
    Kidney insufficiency
         subjects affected / exposed
    2 / 41 (4.88%)
    0 / 42 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 42 (0.00%)
    1 / 39 (2.56%)
         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
    0 / 41 (0.00%)
    0 / 42 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    hyperglycemia
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 42 (2.38%)
    0 / 39 (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
    Infections and infestations
    Anaphylactic shock
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 42 (2.38%)
    0 / 39 (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
    COVID-19 infection
         subjects affected / exposed
    2 / 41 (4.88%)
    0 / 42 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    CRP increased
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 42 (2.38%)
    0 / 39 (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
    Infection
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 42 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 42 (2.38%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Arm A Arm B Arm C
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    40 / 41 (97.56%)
    42 / 42 (100.00%)
    39 / 39 (100.00%)
    Investigations
    Alkaline phosphatase increased
         subjects affected / exposed
    2 / 41 (4.88%)
    1 / 42 (2.38%)
    0 / 39 (0.00%)
         occurrences all number
    2
    1
    0
    Anemia
         subjects affected / exposed
    32 / 41 (78.05%)
    26 / 42 (61.90%)
    25 / 39 (64.10%)
         occurrences all number
    50
    38
    32
    Creatinine increased
         subjects affected / exposed
    1 / 41 (2.44%)
    2 / 42 (4.76%)
    1 / 39 (2.56%)
         occurrences all number
    1
    2
    1
    Leucocytopenia
         subjects affected / exposed
    38 / 41 (92.68%)
    14 / 42 (33.33%)
    12 / 39 (30.77%)
         occurrences all number
    38
    14
    12
    Neutropenia
         subjects affected / exposed
    35 / 41 (85.37%)
    29 / 42 (69.05%)
    34 / 39 (87.18%)
         occurrences all number
    46
    43
    34
    Thrombocytopenia
         subjects affected / exposed
    35 / 41 (85.37%)
    29 / 42 (69.05%)
    29 / 39 (74.36%)
         occurrences all number
    35
    29
    29
    Transaminases increased
         subjects affected / exposed
    14 / 41 (34.15%)
    7 / 42 (16.67%)
    7 / 39 (17.95%)
         occurrences all number
    14
    7
    7
    Cardiac disorders
    Hypertension
         subjects affected / exposed
    3 / 41 (7.32%)
    3 / 42 (7.14%)
    0 / 39 (0.00%)
         occurrences all number
    3
    3
    0
    QTc prolongation
         subjects affected / exposed
    0 / 41 (0.00%)
    3 / 42 (7.14%)
    2 / 39 (5.13%)
         occurrences all number
    0
    3
    2
    Tachycardia
         subjects affected / exposed
    4 / 41 (9.76%)
    2 / 42 (4.76%)
    1 / 39 (2.56%)
         occurrences all number
    4
    2
    1
    Nervous system disorders
    Peripheral neuropathy
         subjects affected / exposed
    1 / 41 (2.44%)
    3 / 42 (7.14%)
    1 / 39 (2.56%)
         occurrences all number
    1
    3
    1
    General disorders and administration site conditions
    Abdominal bloating
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 42 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    0
    0
    2
    Abdominal pain
         subjects affected / exposed
    2 / 41 (4.88%)
    4 / 42 (9.52%)
    3 / 39 (7.69%)
         occurrences all number
    2
    4
    3
    Alopecia
         subjects affected / exposed
    6 / 41 (14.63%)
    0 / 42 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    6
    0
    1
    Anorexia
         subjects affected / exposed
    2 / 41 (4.88%)
    6 / 42 (14.29%)
    6 / 39 (15.38%)
         occurrences all number
    2
    6
    6
    Asthenia
         subjects affected / exposed
    15 / 41 (36.59%)
    20 / 42 (47.62%)
    16 / 39 (41.03%)
         occurrences all number
    15
    20
    16
    Dizziness
         subjects affected / exposed
    2 / 41 (4.88%)
    3 / 42 (7.14%)
    2 / 39 (5.13%)
         occurrences all number
    2
    3
    2
    Dysgeusia
         subjects affected / exposed
    2 / 41 (4.88%)
    2 / 42 (4.76%)
    4 / 39 (10.26%)
         occurrences all number
    2
    2
    4
    Epistaxis
         subjects affected / exposed
    3 / 41 (7.32%)
    0 / 42 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    3
    0
    0
    Fatigue
         subjects affected / exposed
    14 / 41 (34.15%)
    9 / 42 (21.43%)
    11 / 39 (28.21%)
         occurrences all number
    14
    9
    11
    General malaise
         subjects affected / exposed
    1 / 41 (2.44%)
    3 / 42 (7.14%)
    0 / 39 (0.00%)
         occurrences all number
    1
    3
    0
    Headache
         subjects affected / exposed
    2 / 41 (4.88%)
    9 / 42 (21.43%)
    4 / 39 (10.26%)
         occurrences all number
    2
    9
    4
    Insomnia
         subjects affected / exposed
    2 / 41 (4.88%)
    2 / 42 (4.76%)
    3 / 39 (7.69%)
         occurrences all number
    2
    2
    3
    Syncope
         subjects affected / exposed
    0 / 41 (0.00%)
    2 / 42 (4.76%)
    2 / 39 (5.13%)
         occurrences all number
    0
    2
    2
    Weight decreased
         subjects affected / exposed
    2 / 41 (4.88%)
    0 / 42 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    2
    0
    1
    abdominal cramping
         subjects affected / exposed
    3 / 41 (7.32%)
    0 / 42 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    3
    0
    1
    Immune system disorders
    Allergic reaction to Carboplatin
         subjects affected / exposed
    6 / 41 (14.63%)
    10 / 42 (23.81%)
    15 / 39 (38.46%)
         occurrences all number
    6
    10
    15
    Eye disorders
    blurry vision
         subjects affected / exposed
    2 / 41 (4.88%)
    0 / 42 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    2
    0
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    18 / 41 (43.90%)
    12 / 42 (28.57%)
    13 / 39 (33.33%)
         occurrences all number
    18
    12
    13
    Diarrhoea
         subjects affected / exposed
    9 / 41 (21.95%)
    22 / 42 (52.38%)
    32 / 39 (82.05%)
         occurrences all number
    9
    22
    32
    Epigastric pain
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 42 (2.38%)
    2 / 39 (5.13%)
         occurrences all number
    1
    1
    2
    Nausea
         subjects affected / exposed
    32 / 41 (78.05%)
    32 / 42 (76.19%)
    29 / 39 (74.36%)
         occurrences all number
    32
    32
    29
    Pyrosis
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 42 (2.38%)
    2 / 39 (5.13%)
         occurrences all number
    0
    1
    2
    Stomach pain
         subjects affected / exposed
    5 / 41 (12.20%)
    3 / 42 (7.14%)
    2 / 39 (5.13%)
         occurrences all number
    5
    3
    2
    Vomiting
         subjects affected / exposed
    9 / 41 (21.95%)
    15 / 42 (35.71%)
    16 / 39 (41.03%)
         occurrences all number
    9
    15
    16
    Respiratory, thoracic and mediastinal disorders
    Dyspnea
         subjects affected / exposed
    3 / 41 (7.32%)
    6 / 42 (14.29%)
    0 / 39 (0.00%)
         occurrences all number
    3
    6
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    3 / 41 (7.32%)
    0 / 42 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    3
    0
    2
    itching
         subjects affected / exposed
    0 / 41 (0.00%)
    2 / 42 (4.76%)
    0 / 39 (0.00%)
         occurrences all number
    0
    2
    0
    Renal and urinary disorders
    Urinary tract infection
         subjects affected / exposed
    2 / 41 (4.88%)
    1 / 42 (2.38%)
    4 / 39 (10.26%)
         occurrences all number
    2
    1
    4
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 41 (9.76%)
    2 / 42 (4.76%)
    2 / 39 (5.13%)
         occurrences all number
    4
    2
    2
    Myalgia
         subjects affected / exposed
    2 / 41 (4.88%)
    4 / 42 (9.52%)
    0 / 39 (0.00%)
         occurrences all number
    2
    4
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Nov 2018
    Addition of an extra biopsy 24h after the first dose of chemotherapy in 10 patients of UZLeuven. This was added in the scope of companion diagnostics.
    07 Jan 2020
    - Additional clarification of some in- & exclusion criteria - Addition of an exclusion criterion regarding the use of drugs prolonging the QTc interval or with a known risk to cause Torsade de Points - Addition of an exclusion criterion regarding the administration of live attenuated vaccines within 30 days prior to the start of the trial. - Addition of some recently updated information regarding the clinical experience with combining Ganetespib and Carboplatin - Addition of a section regarding the Ganetespib safety profile - Updates in the section ‘diarrhoea’ in the ‘events of special interest with respect to Ganetespib treatment’ - Addition of information regarding the potential overlapping toxicities of Ganetespib and Niraparib - Addition of information regarding the potential overlapping toxicities of Ganetespib and Carboplatin - The information regarding Gemcitabin and Paclitaxel was moved from the section ‘information on the non-investigational products (non-IMPs)’ to the section ‘information on the comparator products (non-IMPs)’ - Addition of a statement that TESARO and Aldeyra Therapeutics agree to provide the study treatment(s) to patients in case of a premature termination of the trial. - Updates to the ‘statistical analysis’ section based on requests received from the CAs and ECs of the participating countries during the trial approval phase. - Clarification of the guidelines on G-CSF use
    12 Nov 2020
    Addition of guidelines on Niraparib dose reductions for patients with hepatotoxicity.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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