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    Clinical Trial Results:
    A Single Arm, Phase 2 Study of Ganetespib in Subjects with Advanced Non- Small-Cell Lung Cancer with Anaplastic Lymphoma Kinase Gene Rearrangement (ALK-Positive NSCLC)

    Summary
    EudraCT number
    		 2012-000639-16
    Trial protocol
    		 GB   ES  
    Global end of trial date
    04 Jul 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Apr 2016
    First version publication date
    02 Apr 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    9090-09
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01562015
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Synta Pharmaceuticals Corp
    Sponsor organisation address
    45 Hartwell Avenue, Lexington, MA, United States, 02421
    Public contact
    VP Clinical Research, Synta Pharmaceuticals Corp, 001 781-541-7261,
    Scientific contact
    VP Clinical Research, Synta Pharmaceuticals Corp, 001 781-541-7261,
    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
    09 Oct 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Jul 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Determine the objective response rate (ORR) of ganetespib in subjects with advanced ALK-positive non-small-cell lung cancer (NSCLC)
    Protection of trial subjects
    The informed consent document must be reviewed and approved by Synta or its designee and the investigative site IRB/IEC prior to the initiation of the study. Prior to the start of any protocol-specific evaluations or screening procedures, the Investigator (or designated staff) will explain the nature of the study and its risks and benefits to the patient (or the patient’s legal representative). Each patient will receive an informed consent document with patient information. Patients should be given ample time to read the information and the opportunity to ask questions. Informed consent must be obtained from each patient prior to performing any protocol-specific evaluations. One copy of the signed informed consent document will be given to the patient, and another will be retained by the Investigator.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Apr 2012
    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
    Canada: 6
    Country: Number of subjects enrolled
    Serbia: 2
    Country: Number of subjects enrolled
    United States: 3
    Country: Number of subjects enrolled
    Bosnia and Herzegovina: 1
    Worldwide total number of subjects
    12
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    6
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 264 patients were screened for possible inclusion in the study. Of these (and due to the rarity of the ALK rearrangement in the NSCLC population), 12 patients were enrolled at 7 study centers.

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

    Arms
    Arm title
    		 Ganetespib 200 mg/m^2
    Arm description
    		 Patients received single-agent ganetespib 200 mg/m^2 once weekly for the first 3 weeks of 4-week treatment cycles (Days 1, 8, and 15 of each 28-day treatment cycle). The amount of ganetespib was calculated based on the patient's body surface area (BSA), determined on Day 1 of each cycle. Ganetespib was administered via an approximately 1-hour peripheral intravenous (IV) infusion, under supervision of study personnel. Patients continued ganetespib treatment until evidence of objective disease progression or symptomatic deterioration, occurrence of unacceptable toxicity, or withdrawal of consent, or early study termination.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ganetespib
    Investigational medicinal product code
    Other name
    STA-9090
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single-agent ganetespib 200 mg/m^2 once weekly for the first 3 weeks of 4-week treatment cycles (Days 1, 8, and 15 of each 28-day treatment cycle). The amount of ganetespib was calculated based on the patient's body surface area (BSA), determined on Day 1 of each cycle. Ganetespib was administered via an approximately 1-hour peripheral intravenous (IV) infusion, under supervision of study personnel.

    Number of subjects in period 1
    		Ganetespib 200 mg/m^2
    Started
    12
    Completed
    0
    Not completed
    12
         Clinical progression
    3
         Consent withdrawn by subject
    2
         Symptomatic deterioration
    2
         Progressive disease
    4
         Sponsor decision
    1

    Baseline characteristics

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

    Reporting group values
    		 Treatment Period Total
    Number of subjects
    		 12 12
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 6 6
        From 65-84 years
    		 6 6
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 58.8 ( 14.66 ) -
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 5 5
    Race
    Units: Subjects
        White/Caucasian
    		 11 11
        Asian
    		 1 1
    Smoking Status
    Units: Subjects
        Never Smoked
    		 8 8
        Past Smoker
    		 2 2
        Current Smoker
    		 2 2
    Stage at Initial Diagnosis
    Units: Subjects
        Stage I/II
    		 1 1
        Stage IIIA
    		 0 0
        Stage IIIB
    		 4 4
        Stage IV
    		 7 7
    Stage at Study Entry
    Units: Subjects
        Stage IIIB
    		 2 2
        Stage IV
    		 10 10
    ECOG at Study Entry
    Eastern Cooperative Oncology Group (ECOG) Performance Status: 0: Fully active 1: Ambulatory, carry out work of a light or sedentary nature
    Units: Subjects
        0: Fully active
    		 6 6
        1: Ambulatory, carry out light work
    		 6 6
    Brain Metastasis
    Units: Subjects
        Yes
    		 3 3
        No
    		 9 9
    Liver Metastasis
    Units: Subjects
        Yes
    		 4 4
        No
    		 8 8
    Lung Metastasis
    Units: Subjects
        Yes
    		 9 9
        No
    		 3 3
    Lymph Nodes Metastasis
    Units: Subjects
        Yes
    		 5 5
        No
    		 7 7
    Bone Metastasis
    Units: Subjects
        Yes
    		 4 4
        No
    		 8 8
    Pleura Metastasis
    Units: Subjects
        Yes
    		 5 5
        No
    		 7 7
    Adrenal Metastasis
    Units: Subjects
        Yes
    		 2 2
        No
    		 10 10
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 71.92 ( 12.719 ) -
    Body Surface Area (BSA)
    Units: m^2
        arithmetic mean (standard deviation)
    		 1.808 ( 0.199 ) -
    Number of Metasatic Sites
    Units: sites
        arithmetic mean (standard deviation)
    		 3.67 ( 2.188 ) -
    Baseline Total Tumor Burden
    Units: mm
        arithmetic mean (standard deviation)
    		 80.5 ( 37.876 ) -

    End points

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    End points reporting groups
    Reporting group title
    Ganetespib 200 mg/m^2
    Reporting group description
    		 Patients received single-agent ganetespib 200 mg/m^2 once weekly for the first 3 weeks of 4-week treatment cycles (Days 1, 8, and 15 of each 28-day treatment cycle). The amount of ganetespib was calculated based on the patient's body surface area (BSA), determined on Day 1 of each cycle. Ganetespib was administered via an approximately 1-hour peripheral intravenous (IV) infusion, under supervision of study personnel. Patients continued ganetespib treatment until evidence of objective disease progression or symptomatic deterioration, occurrence of unacceptable toxicity, or withdrawal of consent, or early study termination.

    Subject analysis set title
    All Patients
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Includes all 12 patients treated with ganetespib 200 mg/m^2.

    Subject analysis set title
    FISH Positive ALK Patients
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Patients deemed positive anaplastic lymphoma kinase (ALK) by the Vysis fluorescence in situ hybridization (FISH) assay, which was performed on all tumor samples determined to be ALK-positive by a central laboratory using immunohistochemistry (IHC).

    Primary: Objective Response Rate

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    End point title
    		 Objective Response Rate [1]
    End point description
    The primary endpoint of the study is objective response rate (ORR) which is the percentage of patients showing a complete or partial response. - Complete Response (CR): Disappearance (or normalization) of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had reduction in SA to <10 mm. - Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions compared to the baseline sum.
    End point type
    Primary
    End point timeframe
    Week 6 - Week 92
    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: No statistics since the study populations were small due to early termination.
    End point values
    		 All Patients FISH Positive ALK Patients
    Number of subjects analysed
    12
    8
    Units: percentage of patients
        number (confidence interval 95%)
    8.3 (0.2 to 38.5)
    12.5 (0.3 to 52.7)
    No statistical analyses for this end point

    Secondary: Progression Free Survival (PFS) Rate at 6 months

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    End point title
    		 Progression Free Survival (PFS) Rate at 6 months
    End point description
    PFS means the patient was alive and progression free. Progression was the interval from the date of first dose until objective tumor progression per RECIST 1.1 or death from any cause, whichever occurred first.
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 All Patients FISH Positive ALK Patients
    Number of subjects analysed
    12
    8
    Units: percentage of patients
        number (confidence interval 95%)
    33.3 (9.9 to 65.1)
    37.5 (8.5 to 75.5)
    No statistical analyses for this end point

    Secondary: Progression Free Survival (PFS) Rate at 12 Months

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    End point title
    		 Progression Free Survival (PFS) Rate at 12 Months
    End point description
    PFS means the patient was alive and progression free. Progression was the interval from the date of first dose until objective tumor progression per RECIST 1.1 or death from any cause, whichever occurred first.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 All Patients FISH Positive ALK Patients
    Number of subjects analysed
    12
    8
    Units: percentage of patients
        number (confidence interval 95%)
    16.7 (2.1 to 48.4)
    12.5 (0.3 to 52.7)
    No statistical analyses for this end point

    Secondary: Progression Free Survival (PFS) Rate at 18 months

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    End point title
    		 Progression Free Survival (PFS) Rate at 18 months
    End point description
    PFS means the patient was alive and progression free. Progression was the interval from the date of first dose until objective tumor progression per RECIST 1.1 or death from any cause, whichever occurred first.
    End point type
    Secondary
    End point timeframe
    18 months
    End point values
    		 All Patients FISH Positive ALK Patients
    Number of subjects analysed
    12
    8
    Units: percentage of patients
        number (confidence interval 95%)
    8.3 (0.2 to 38.5)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Duration of Response

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    End point title
    		 Duration of Response
    End point description
    Duration of Response (DOR) was defined as the date of first documented objective response (complete response or partial response, whichever status is recorded first) to the earliest date that progressive disease is objectively documented. If progression has not been documented, a subject’s duration of objective response will be censored at the date of last assessment.
    End point type
    Secondary
    End point timeframe
    Week 6 - Week 92
    End point values
    		 All Patients FISH Positive ALK Patients
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: weeks
        median (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [2] - Data not analyzed because of the small number of patients.
    [3] - Data not analyzed because of the small number of patients.
    No statistical analyses for this end point

    Secondary: Overall Survival (OS) and 1-Year OS

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    End point title
    		 Overall Survival (OS) and 1-Year OS
    End point description
    Overall Survival (OS) was defined as the time from the first dose until death due to any cause. Subjects who are lost to follow-up were censored at the time of the last contact.
    End point type
    Secondary
    End point timeframe
    up to 2 years
    End point values
    		 All Patients FISH Positive ALK Patients
    Number of subjects analysed
    0 [4]
    0 [5]
    Units: months
        median (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [4] - Data not analyzed because of the small number of patients.
    [5] - Data not analyzed because of the small number of patients.
    No statistical analyses for this end point

    Secondary: Disease Control Rate (DSR) at Weeks 6 and 12

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    End point title
    		 Disease Control Rate (DSR) at Weeks 6 and 12
    End point description
    The DCR was defined as the percentage of patients with best response of complete response, partial response, or stable disease, where the stable disease must have been for at least 6 or 12 weeks (according to modified RECIST 1.1). - Complete Response (CR): Disappearance (or normalization) of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had reduction in SA to <10 mm. - Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions compared to the baseline sum. - Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study.
    End point type
    Secondary
    End point timeframe
    Weeks 6 and 12
    End point values
    		 All Patients FISH Positive ALK Patients
    Number of subjects analysed
    12
    8
    Units: percentage of patients
    number (confidence interval 95%)
        Week 6
    83.3 (51.6 to 97.9)
    75 (34.9 to 96.8)
        Week 12
    50 (21.1 to 78.9)
    50 (15.7 to 84.3)
    No statistical analyses for this end point

    Secondary: Change in Tumor Size (CTS) at Weeks 6 and 12

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    End point title
    		 Change in Tumor Size (CTS) at Weeks 6 and 12
    End point description
    Change in Tumor Size (CTS) is measured from baseline to at least 6 weeks (CTS-6) or 12 weeks (CTS-12)
    End point type
    Secondary
    End point timeframe
    Day 1 (baseline), Weeks 6 and 12
    End point values
    		 All Patients FISH Positive ALK Patients
    Number of subjects analysed
    0 [6]
    0 [7]
    Units: mm
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [6] - Data not analyzed because of the small number of patients.
    [7] - Data not analyzed because of the small number of patients.
    No statistical analyses for this end point

    Secondary: Clinically Relevant Improvement in Disease Symptoms Using Functional Assessment of Cancer Therapy - Lung (FACT-L)

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    End point title
    		 Clinically Relevant Improvement in Disease Symptoms Using Functional Assessment of Cancer Therapy - Lung (FACT-L)
    End point description
    The responses to the FACT-L were transformed and the LCS sores will be calculated. Subjects were rated as improved, no change, or worsened according to their scores compared with baseline. Missing data points were counted as no change in symptoms. Clinically relevant improvement, defined as 2-point improvement maintained for at least 21 days, were calculated.
    End point type
    Secondary
    End point timeframe
    Day 1 (baseline) up to Week 92
    End point values
    		 All Patients FISH Positive ALK Patients
    Number of subjects analysed
    0 [8]
    0 [9]
    Units: percentage of patients
        number (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [8] - Data not analyzed because of the small number of patients.
    [9] - Data not analyzed because of the small number of patients.
    No statistical analyses for this end point

    Secondary: Participants with Treatment-Emergent Adverse Events (AEs)

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    End point title
    		 Participants with Treatment-Emergent Adverse Events (AEs)
    End point description
    At each summarization level, a patient is counted once if the patient reported one or more events. National Cancer Institute (NCI) Common Terminology Criteria (NCI-CTCAE V4) is a scale of the severity of the AE. CTCAE grade 3 is severe (the AE is intolerable and disrupts normal daily activities, may require additional therapy or hospitalization, and/or discontinuation of the study drug), and grade 4 is life threatening (the AE exposes the subject to risk of death at the time of the event; it does not refer to an event that may have caused death if the event was more severe).
    End point type
    Secondary
    End point timeframe
    Day 1 up to Week 92
    End point values
    		 Ganetespib 200 mg/m^2
    Number of subjects analysed
    12
    Units: participants
        >=1 AE
    11
        >= 1 AE with CTCAE grade 3 or 4
    7
        >=1 serious AE
    4
        >=1 AE leading to dose reduction
    0
        >=1 AE leading to delayed dose
    3
        >=1 AE leading to study drug d/c
    0
        >=1 serious AE leading to study drug
    0
        >=1 SAE leading to hospitalization
    3
        >=1 AE with outcome of death
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 to Week 92
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Ganetespib 200 mg/m^2
    Reporting group description
    		 Patients received single-agent ganetespib 200 mg/m^2 once weekly for the first 3 weeks of 4-week treatment cycles (Days 1, 8, and 15 of each 28-day treatment cycle). The amount of ganetespib was calculated based on the patient's body surface area (BSA), determined on Day 1 of each cycle. Ganetespib was administered via an approximately 1-hour peripheral intravenous (IV) infusion, under supervision of study personnel. Patients continued ganetespib treatment until evidence of objective disease progression or symptomatic deterioration, occurrence of unacceptable toxicity, or withdrawal of consent, or early study termination.

    Serious adverse events
    		 Ganetespib 200 mg/m^2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 12 (33.33%)
         number of deaths (all causes)
    2
         number of deaths resulting from adverse events
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Sudden cardiac death
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia aspiration
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Ganetespib 200 mg/m^2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 12 (91.67%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer pain
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    2
    Tumour pain
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Vascular disorders
    Flushing
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Hot flush
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Hypertension
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    2
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    3 / 12 (25.00%)
         occurrences all number
    4
    Fatigue
         subjects affected / exposed
    9 / 12 (75.00%)
         occurrences all number
    12
    Feeling jittery
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    2
    Influenza like illness
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Infusion site reaction
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Non-cardiac chest pain
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    5
    Oedema peripheral
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Pyrexia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    6 / 12 (50.00%)
         occurrences all number
    7
    Hiccups
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    3
    Productive cough
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Insomnia
         subjects affected / exposed
    5 / 12 (41.67%)
         occurrences all number
    7
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    3
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    4 / 12 (33.33%)
         occurrences all number
    7
    Blood bilirubin increased
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    2
    Electrocardiogram QT prolonged
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Electrocardiogram T wave abnormal
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Lipase increased
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    2
    Urine output decreased
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Weight decreased
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    2
    Procedural pain
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Tachycardia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Dizziness
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    3
    Dysgeusia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    3 / 12 (25.00%)
         occurrences all number
    3
    Peripheral sensory neuropathy
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 12 (33.33%)
         occurrences all number
    10
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Vision blurred
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Abdominal pain
         subjects affected / exposed
    3 / 12 (25.00%)
         occurrences all number
    3
    Constipation
         subjects affected / exposed
    4 / 12 (33.33%)
         occurrences all number
    5
    Diarrhoea
         subjects affected / exposed
    9 / 12 (75.00%)
         occurrences all number
    92
    Dysphagia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    3
    Gastrointestinal pain
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    2
    Nausea
         subjects affected / exposed
    4 / 12 (33.33%)
         occurrences all number
    7
    Stomatitis
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    3 / 12 (25.00%)
         occurrences all number
    8
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Dermatitis allergic
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    2
    Dry skin
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Erythema
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Urinary retention
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Bone pain
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Groin pain
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Muscle spasms
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Musculoskeletal pain
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Spinal pain
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    3
    Infections and infestations
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Tooth infection
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    6 / 12 (50.00%)
         occurrences all number
    8
    Dehydration
         subjects affected / exposed
    4 / 12 (33.33%)
         occurrences all number
    10
    Hyperglycaemia
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    4
    Hyperkalaemia
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    2
    Hypokalaemia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Hyponatraemia
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    An enrollment of 110 patients was planned; however, the study was terminated after 12 patients were enrolled due to the low level of clinical activity observed in these patients and the changing landscape for the treatment of this population.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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