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    Clinical Trial Results:
    A phase II trial to assess the activity and safety of TH-302 in combination with sunitinib in patients with well- and moderately-differentiated metastatic pancreatic neuroendocrine tumors (pNET) previously untreated

    Summary
    EudraCT number
    		 2014-004072-30
    Trial protocol
    		 ES  
    Global end of trial date
    10 Jan 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jul 2020
    First version publication date
    01 Jul 2020
    Other versions
    Summary report(s)
    		 ICH3 summary

    Trial information

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    Trial identification
    Sponsor protocol code
    GETNE-1408
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02402062
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Grupo Español de Tumores Neuroendocrinos y Endocrinos (GETNE)
    Sponsor organisation address
    C/ Pau Alsina 68 esc B entlo. 5, Barcelona, Spain, 08024
    Public contact
    Dr. Jaume Capdevila Castillón, Grupo Español de Tumores Neuroendocrinos y Endocrinos (GETNE), getne@getne.org
    Scientific contact
    Dr. Enrique Grande, Medical Oncology. Hospital Ramon y Cajal, egrande@oncologiahrc.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
    22 May 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jan 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the safety and activity of TH-302 in combination with sunitinib in patients with a well- or moderately-differentiated metastatic pancreatic neuroendocrine tumour (pNET). Efficacy assessed by Objective Response Rate (ORR).
    Protection of trial subjects
    The Sponsor provides compliance with the principles originated from the Helsinki declaration, the Good Clinical Practice requirements from the International Conference of Harmonization (ICH) for the conduct of clinical trials and the local current legislation (European Directive 2001/20/EC)(Real Decreto de Ensayos Clínicos 223/2004). The Sponsor guarantees compliance with the principles established in the Organic Law for Protection of Personal Data 15/1999 and to facilitate the exercise of rights of access, rectification, cancellation and opposition. To ensure patient safety the experimental treatment will be temporarily interrupted until resolution of toxicity ≤ grade 2.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 May 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 17
    Worldwide total number of subjects
    17
    EEA total number of subjects
    17
    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)
    10
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between May/2015 and May/2018, 21 patients were screened and finally 17 were included. 4 patients were excluded because screening failure.

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 21 [1]
    Number of subjects completed
    		 17

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Not meeting inclusion criteria: 4
    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: 4 patients were screened but did not match inclusion criteria so they were not included in the study.
    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Experimental arm
    Arm description
    		 Treatment with TH-302 administered at 340 mg/m2 by intravenous infusion on days 8 and 22 in combination with Sunitinib given orally at doses of 37.5 mg per day continuously in 28-day cycles.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sunitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Sunitinib given orally at doses of 37.5 mg per day continuously. The treatment was maintained until disease progression, unacceptable toxicity, non-compliance with the protocol, the patient’s withdrawal of informed consent or at the discretion of the investigator.

    Investigational medicinal product name
    TH-302
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    TH-302 administered at 340 mg/m2 by intravenous infusion on days 8 and 22 of 28 days cycle. The treatment was maintained until disease progression, unacceptable toxicity, non-compliance with the protocol, the patient’s withdrawal of informed consent or at the discretion of the investigator.

    Number of subjects in period 1
    		Experimental arm
    Started
    17
    Completed
    17
    Period 2
    Period 2 title
    Treatment
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Experimental arm
    Arm description
    		 Treatment with TH-302 administered at 340 mg/m2 by intravenous infusion on days 8 and 22 in combination with Sunitinib given orally at doses of 37.5 mg per day continuously in 28-day cycles.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sunitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Sunitinib given orally at doses of 37.5 mg per day continuously. The treatment was maintained until disease progression, unacceptable toxicity, non-compliance with the protocol, the patient’s withdrawal of informed consent or at the discretion of the investigator.

    Investigational medicinal product name
    TH-302
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    TH-302 administered at 340 mg/m2 by intravenous infusion on days 8 and 22 of 28 days cycle. The treatment was maintained until disease progression, unacceptable toxicity, non-compliance with the protocol, the patient’s withdrawal of informed consent or at the discretion of the investigator.

    Number of subjects in period 2
    		Experimental arm
    Started
    17
    Completed
    7
    Not completed
    10
         Adverse event, serious fatal
    1
         Adverse event, non-fatal
    4
         Lack of efficacy
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 -

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 17 17
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (standard deviation)
    		 60.78 ( 10.78 ) -
    Gender categorical
    Units: Subjects
        Female
    		 6 6
        Male
    		 11 11
    ECOG PS
    The ECOG scale is a practical way to measure the quality of life of a patient exclusively with cancer or cancer.
    Units: Subjects
        grade 0
    		 11 11
        grade 1
    		 6 6
    Ethnicity
    Units: Subjects
        White
    		 17 17
    Electrocardiogram (ECG)
    Units: Subjects
        QT interval longer than 450ms
    		 17 17
    Left ventricular ejection fraction (LVEF)
    Units: Subjects
        higher than 50%
    		 17 17
    Abbreviated Charlson comorbidity index
    Units: Subjects
        index 2
    		 11 11
        index 3
    		 4 4
        index 4
    		 2 2
    Peripheral arterial disease
    Units: Subjects
        Yes
    		 1 1
        No
    		 16 16
    Diabetes
    Units: Subjects
        Yes
    		 5 5
        No
    		 12 12
    Tumor histological grade
    Units: Subjects
        grade 2
    		 15 15
        grade 1
    		 2 2
    Ki-67 index
    Units: Subjects
        >10%
    		 8 8
        >2%-5%
    		 5 5
        >5%-10%
    		 4 4
    Mitosis 10 HPF
    Units: Subjects
        Unknown
    		 6 6
        <2
    		 6 6
        2-20
    		 5 5
    Primary tumor surgery
    Units: Subjects
        Yes
    		 6 6
        No
    		 11 11
    Tumor stage at diagnosis
    Units: Subjects
        II
    		 3 3
        III
    		 1 1
        IV
    		 13 13
    Tumor relapse location
    Units: Subjects
        Hepatic
    		 12 12
        unknown
    		 4 4
        Extra-hepatic
    		 1 1
    Somatostanine analogues prior the trial
    Units: Subjects
        Yes
    		 7 7
        No
    		 10 10
    Baseline concomitant medication
    Units: Subjects
        Yes
    		 16 16
        No
    		 1 1
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 70.97 ( 15.01 ) -
    Height
    Units: centimeter
        arithmetic mean (standard deviation)
    		 166.71 ( 7.74 ) -
    Body mass index (BMI)
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 25.46 ( 4.75 ) -
    Body surface area (BSA)
    Units: m2
        arithmetic mean (standard deviation)
    		 1.79 ( 0.20 ) -
    Blood pressure systolic (BPs)
    Units: mmHg
        arithmetic mean (standard deviation)
    		 134.82 ( 10.95 ) -
    Blood pressure diastolic (BPd)
    Units: mmHg
        arithmetic mean (standard deviation)
    		 79.12 ( 7.42 ) -
    Haemoglobin
    Units: g/dL
        arithmetic mean (standard deviation)
    		 13.82 ( 1.21 ) -
    White blood cells
    Units: x109/L
        arithmetic mean (standard deviation)
    		 6.22 ( 2.17 ) -
    Absolute neutrophil count
    Units: x109/L
        arithmetic mean (standard deviation)
    		 4.52 ( 1.84 ) -
    Absolute Lymphocytes count
    Units: x109/L
        arithmetic mean (standard deviation)
    		 1.69 ( 0.41 ) -
    Platelet count
    Units: x109/L
        arithmetic mean (standard deviation)
    		 202.94 ( 77.34 ) -
    Sodium
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 139.22 ( 3.06 ) -
    Potassium
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 4.35 ( 0.35 ) -
    Calcium
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 9.18 ( 1.83 ) -
    Magnesium
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 1.9 ( 0.38 ) -
    Glucose
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 133.44 ( 59.92 ) -
    Creatinine
    Units: mg/dL
        arithmetic mean (standard deviation)
    		 0.76 ( 0.17 ) -
    Aspartate AST (SGOT)
    Units: u/L
        arithmetic mean (standard deviation)
    		 48.95 ( 40.18 ) -
    Alanine transaminase ALT (SGPT)
    Units: u/L
        arithmetic mean (standard deviation)
    		 69.63 ( 61.12 ) -
    AST (SGOT)/ ALT (SGPT) (baseline)
    Units: Arbitrary units
        arithmetic mean (standard deviation)
    		 0.83 ( 0.30 ) -
    Total bilirubin
    Units: mg/dL
        arithmetic mean (standard deviation)
    		 0.86 ( 0.58 ) -
    Gamma-glutamyltransferase (GGT)
    Units: u/L
        arithmetic mean (standard deviation)
    		 351.25 ( 488.76 ) -
    Alkaline phosphatase (AP)
    Units: u/L
        arithmetic mean (standard deviation)
    		 201.64 ( 183.95 ) -
    Albumin
    Units: mg/dL
        arithmetic mean (standard deviation)
    		 4.28 ( 0.43 ) -
    Lactate dehydrogenase (LDH)
    Units: u/L
        arithmetic mean (standard deviation)
    		 216.88 ( 83.41 ) -
    CG a tumor marker
    Units: ng/L
        arithmetic mean (standard deviation)
    		 474.41 ( 626.35 ) -
    Enolase 1
    Units: ng/mL
        arithmetic mean (standard deviation)
    		 31.92 ( 31.08 ) -
    Time between diagnosis (anatomical pathology) and treatment initiation (date 1 cycle 1) in months
    Units: Months
        arithmetic mean (standard deviation)
    		 14.12 ( 22.72 ) -
    Time between diagnosis (anatomical pathology) and surgery in months
    Units: Months
        arithmetic mean (standard deviation)
    		 1.1 ( 2.94 ) -
    Time between diagnosis (anatomical pathology) and CT relapse in months
    Units: Months
        arithmetic mean (standard deviation)
    		 8.9 ( 13.77 ) -

    End points

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    End points reporting groups
    Reporting group title
    Experimental arm
    Reporting group description
    		 Treatment with TH-302 administered at 340 mg/m2 by intravenous infusion on days 8 and 22 in combination with Sunitinib given orally at doses of 37.5 mg per day continuously in 28-day cycles.
    Reporting group title
    Experimental arm
    Reporting group description
    		 Treatment with TH-302 administered at 340 mg/m2 by intravenous infusion on days 8 and 22 in combination with Sunitinib given orally at doses of 37.5 mg per day continuously in 28-day cycles.

    Primary: Overal response rate (ORR)

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    End point title
    		 Overal response rate (ORR) [1]
    End point description
    ORR will be evaluated according to the RECIST v 1.1 criteria that will be carried out every 8 weeks, regardless of delays in treatment secondary to treatment toxicity. ORR is defined as the percentage of patients in whom a complete response is confirmed (CR) or a partial response (RP) according to RECIST criteria, in relation to the total population analyzed. An answer is confirmed in those patients in whom this response persists in a test of repeat image ≥4 weeks after initial response documentation.
    End point type
    Primary
    End point timeframe
    every 8 weeks since start of treatment
    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: This study had only one treatment arm, so no comparison between groups was assessed. The main aim was to characterize the outcomes in the population of study when treated with TH302 and sunitinib combination.
    End point values
    		 Experimental arm
    Number of subjects analysed
    17
    Units: Patients
        CR or PR
    3
        No CR or PR
    14
    No statistical analyses for this end point

    Primary: Best response (not confirmed)

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    End point title
    		 Best response (not confirmed) [2]
    End point description
    Best response to treatment achieved following RECIST v1.1 criteria. The best response is not confirmed in the following evaluation timepoints.
    End point type
    Primary
    End point timeframe
    Every 8 weeks from start of treatment.
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study had only one treatment arm, so no comparison between groups was assessed. The main aim was to characterize the outcomes in the population of study when treated with TH302 and sunitinib combination.
    End point values
    		 Experimental arm
    Number of subjects analysed
    17
    Units: Patients
        CR
    1
        PR
    3
        SD
    11
        PD
    1
        NE
    1
    No statistical analyses for this end point

    Primary: Confirmed response for objective response rate

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    End point title
    		 Confirmed response for objective response rate [3]
    End point description
    End point type
    Primary
    End point timeframe
    Every 8 weeks from start of treatment
    Notes
    [3] - 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: This study had only one treatment arm, so no comparison between groups was assessed. The main aim was to characterize the outcomes in the population of study when treated with TH302 and sunitinib combination.
    End point values
    		 Experimental arm
    Number of subjects analysed
    17
    Units: Patients
        CR
    1
        PR
    2
        SD
    11
        PD
    1
        NE
    2
    No statistical analyses for this end point

    Secondary: Progression-free survival (PFS)

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    End point title
    		 Progression-free survival (PFS)
    End point description
    PFS is defined as the time between the start of the study treatment until the date of the first objective evidence of radiological progression or death of the patient due to any cause; whichever happen first.
    End point type
    Secondary
    End point timeframe
    every 8 weeks
    End point values
    		 Experimental arm
    Number of subjects analysed
    17 [4]
    Units: months
        median (confidence interval 95%)
    10.38 (2.66 to 18.1)
    Attachments
    		 Kaplan Meier graph for PFS
    Notes
    [4] - 11 events recorded along the study. 6 censored.
    No statistical analyses for this end point

    Secondary: Time to progression

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    End point title
    		 Time to progression
    End point description
    Time to progression is defined as the time between the start of the study treatment until the date of the first objective evidence of radiological progression.
    End point type
    Secondary
    End point timeframe
    Every 8 weeks from the treatment start until disease progression, patient death or withdrawal, whichever occurs first.
    End point values
    		 Experimental arm
    Number of subjects analysed
    17
    Units: months
        median (full range (min-max))
    5.32 (1.69 to 13.55)
    No statistical analyses for this end point

    Secondary: Response duration (RD)

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    End point title
    		 Response duration (RD)
    End point description
    RD is defined as the time between the start from the first objective response documentation (CR or PR) which is subsequently confirmed, until the first objective evidence of radiological progression or death from any cause. RD will be calculated only in the subgroup of patients with objective response (CR + PR).
    End point type
    Secondary
    End point timeframe
    Every 8 weeks from the start of treatment until disease progression, patient death or withdrawal, whichever occurs first.
    End point values
    		 Experimental arm
    Number of subjects analysed
    17
    Units: months
        median (full range (min-max))
    18.48 (4.20 to 38.31)
    No statistical analyses for this end point

    Secondary: Overall survival (OS)

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    End point title
    		 Overall survival (OS)
    End point description
    OS is defined as the time between the start of study treatment until the date of death due to any cause. If it is not possible to obtain confirmation of death, survival will be censored with the date of the last visit that the patient is known to be alive.
    End point type
    Secondary
    End point timeframe
    Every 8 weeks from the start of treatment until patient death or withdrawal, whichever occurs first.
    End point values
    		 Experimental arm
    Number of subjects analysed
    17
    Units: months
        arithmetic mean (confidence interval 95%)
    32.32 (25.12 to 39.53)
    Attachments
    		 Kaplan Meier graph for OS
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    Experimental arm
    Reporting group description
    		 Treatment with TH-302 administered at 340 mg/m2 by intravenous infusion on days 8 and 22 in combination with Sunitinib given orally at doses of 37.5 mg per day continuously in 28-day cycles.

    Serious adverse events
    		 Experimental arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 17 (17.65%)
         number of deaths (all causes)
    3
         number of deaths resulting from adverse events
    1
    General disorders and administration site conditions
    Fever
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fatigue
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Biliary duct obstruction
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Endocrine disorders
    Pancreatitis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Experimental arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 17 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    6 / 17 (35.29%)
         occurrences all number
    6
    Vascular disorders - Other, brachial vein thrombosis
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    14 / 17 (82.35%)
         occurrences all number
    14
    General disorders and administration site conditions - Other, epigastralgia
         subjects affected / exposed
    3 / 17 (17.65%)
         occurrences all number
    3
    Fever
         subjects affected / exposed
    3 / 17 (17.65%)
         occurrences all number
    3
    Dizziness
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Abdominal pain
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Vaginal inflammation
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Reproductive system and breast disorders - Other, genital dryness
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Mucositis oral
         subjects affected / exposed
    10 / 17 (58.82%)
         occurrences all number
    10
    Epistaxis
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders - thoracic pain
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 17 (23.53%)
         occurrences all number
    4
    Myalgia
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Dysesthesia
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Peripheral motor neuropathy
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Paresthesia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Neutrophil count decreased
         subjects affected / exposed
    9 / 17 (52.94%)
         occurrences all number
    9
    Platelet count decreased
         subjects affected / exposed
    5 / 17 (29.41%)
         occurrences all number
    5
    Alanine aminotransferase increased
         subjects affected / exposed
    3 / 17 (17.65%)
         occurrences all number
    3
    Blood bilirubin increased
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Anemia
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    White blood cell decreased
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Hypocalcemia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Bilirrubin increased
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Gastrointestinal disorders
    Diarrhea
         subjects affected / exposed
    9 / 17 (52.94%)
         occurrences all number
    9
    Dyspepsia
         subjects affected / exposed
    3 / 17 (17.65%)
         occurrences all number
    3
    Gastroesophageal reflux disease
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Dysphagia
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Rectal hemorrhage
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Hemorrhoids
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Gastrointestinal disorders - Other, specify: aerophagia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Gastrointestinal disorders - Other, specify: acute gastroenteritis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Gastrointestinal disorders - Other, glossitis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Gastrointestinal disorders - Other, Gingivitis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Esophagitis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Anal ulcer
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Anal pain
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Palmar-plantar erythrodysesthesia syndrome
         subjects affected / exposed
    5 / 17 (29.41%)
         occurrences all number
    5
    Rash acneiform
         subjects affected / exposed
    4 / 17 (23.53%)
         occurrences all number
    4
    Skin hypopigmentation
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders - Other, Erythema
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Skin induration
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Skin hyperpigmentation
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders - Other, specify: Unspecified Onycopathy
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders - Other, specify: Psoriasis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders - Other, Inguinal cutaneous toxicity
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders - Other, facial rash
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders - Other, eczematous facial rash
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Erythroderma
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Dry skin
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Alopecia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Renal and urinary disorders
    Hematuria
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Infections and infestations
    Constipation
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Pharyngitis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Nail infection
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    7 / 17 (41.18%)
         occurrences all number
    7
    Dysgeusia
         subjects affected / exposed
    6 / 17 (35.29%)
         occurrences all number
    6
    Nausea
         subjects affected / exposed
    5 / 17 (29.41%)
         occurrences all number
    5
    Vomiting
         subjects affected / exposed
    4 / 17 (23.53%)
         occurrences all number
    4
    Pancreatitis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Mar 2015
    Change in the labels of Sunitinib 37,5 mg y 25 mg
    07 May 2015
    Quality IMPD of TH-302 v4.0 from november 2014
    04 Aug 2015
    New version of the protocol v. 3.0 from June 8th, 2015
    15 Jan 2016
    New version of the protocol v. 4.0 from November 27th, 2015 New label of TH-302
    13 Jan 2017
    New version of the protocolo v. 5.0 from November 23rd, 2016 New version of the patient information sheet, v. 5.0 from November 23rd, 2016
    25 Oct 2017
    Change of principal investigator from the Ramón y Cajal Hospital
    06 Feb 2018
    Change of the information in the label of TH-302
    12 Feb 2019
    New version of the protocol and patient information sheet v. 6.0 of January 8, 2019

    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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