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    Clinical Trial Results:
    A phase II study of ABT-263 as single agent in women with platinum resistant/refractory recurrent ovarian cancer

    Summary
    EudraCT number
    		 2015-000193-35
    Trial protocol
    		 FR  
    Global end of trial date
    08 Mar 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Mar 2021
    First version publication date
    27 Mar 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MONAVI-1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02591095
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Centre François Baclesse
    Sponsor organisation address
    3 Avenue du Général Harris, CAEN, France,
    Public contact
    LECONTE, Centre François Baclesse, 33 0231455002, a.leconte@baclesse.unicancer.fr
    Scientific contact
    JOLY, Centre François Baclesse, 33 0231455002, f.joly@baclesse.unicancer.fr
    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
    15 Jan 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Jan 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Mar 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine activity of ABT-263 for patients with a platinum resistant/refractory recurrent ovarian cancer
    Protection of trial subjects
    Independent data monitoring committee
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Jan 2016
    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
    France: 47
    Worldwide total number of subjects
    47
    EEA total number of subjects
    47
    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)
    26
    From 65 to 84 years
    21
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 52 patients in screening

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Navitoclax
    Arm description
    		 Patients will be treated with oral Navitoclax (ABT-263) 150 mg daily for the Lead-in Period (7 to 14 days maximum, depends on platelets level). A subject may only proceed from the Lead-in Period to the defined dose level of 250 mg daily for Cycle 1 Day 1 and beyond if platelet count is ≥ 50,000/mm3 and platelets are stable or rising and thereafter. Cycle duration is defined as 21 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Navitoclax
    Investigational medicinal product code
    ABT263
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    250 mg daily

    Number of subjects in period 1 [1]
    		Navitoclax
    Started
    46
    Completed
    46
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 1 patient has been included in the study but not received the treatment according to investigator's decision

    Baseline characteristics

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

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 46 46
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 26 26
        From 65-84 years
    		 20 20
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 63 (38 to 80) -
    Gender categorical
    Units: Subjects
        Female
    		 46 46
        Male
    		 0 0
    Subject analysis sets

    Subject analysis set title
    Efficacy
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Efficacy set is defined as patients who received at least one treatment dose and for which at least two tumor assessment are available (baseline and after treamtent).

    Subject analysis set title
    Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients who received at least one dose of treatment.

    Subject analysis sets values
    		 Efficacy Safety
    Number of subjects
    44
    46
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    24
    26
        From 65-84 years
    20
    20
        85 years and over
    0
    0
    Age continuous
    Units: years
        median (full range (min-max))
    Gender categorical
    Units: Subjects
        Female
    44
    46
        Male
    0
    0

    End points

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    End points reporting groups
    Reporting group title
    Navitoclax
    Reporting group description
    		 Patients will be treated with oral Navitoclax (ABT-263) 150 mg daily for the Lead-in Period (7 to 14 days maximum, depends on platelets level). A subject may only proceed from the Lead-in Period to the defined dose level of 250 mg daily for Cycle 1 Day 1 and beyond if platelet count is ≥ 50,000/mm3 and platelets are stable or rising and thereafter. Cycle duration is defined as 21 days.

    Subject analysis set title
    Efficacy
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Efficacy set is defined as patients who received at least one treatment dose and for which at least two tumor assessment are available (baseline and after treamtent).

    Subject analysis set title
    Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients who received at least one dose of treatment.

    Primary: Progression-Free Survival

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    End point title
    		 Progression-Free Survival
    End point description
    Primary endpoint is the Progression-Free Survival median time. Using a Case & Morgan EDA two-stage design with a 10% one-sided alpha risk and a power of 85%, and the following assumptions : H0 : median PFS <= 2.5 months is equivalent with a 3-month PFS rate <= 0.435 H1 : median PFS >= 4.5 months is equivalent with a 3-month PFS rate >= 0.630 19 assessable patients were needed to be included in the first step. Except if the interim analysis would conclude the study had to be stopped for futility, 22 additional patients had to be enrolled for a total of 41 assessable patients. Interim analysis has not been performed since the total number of evaluable patients has been reached faster than planned (9 months instead of 24 months), during the data monitoring (inclusions were not suspended during this time, as planned in the protocol). Efficacy was evaluated at final analysis only. At the final analysis, the Case & Morgan test statistic Z2=-4.86 > C2=1.188
    End point type
    Primary
    End point timeframe
    Date extraction done on march 8th 2019
    End point values
    		 Navitoclax Efficacy
    Number of subjects analysed
    44
    44
    Units: months
        median (confidence interval 95%)
    1.64 (1.59 to 2.30)
    1.64 (1.59 to 2.30)
    Attachments
    		 Progression-Free Survival
    Statistical analysis title
    		 Further results
    Statistical analysis description
    3-month Progression-Free Survival Rate, with 95% confidence interval.
    Comparison groups
    Navitoclax v Efficacy
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 3-month PFS rate
    Point estimate
    22.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 13.18
         upper limit
    		 39.2

    Secondary: Clinical response

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    End point title
    		 Clinical response
    End point description
    End point type
    Secondary
    End point timeframe
    over the period of study
    End point values
    		 Efficacy
    Number of subjects analysed
    44
    Units: patients
    16
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Database extracted on march 5th 2019.
    Adverse event reporting additional description
    All serious adverse events have been reported. Only adverse events observed in at least 5% of patients have been reported.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Overall
    Reporting group description
    		 Data about death has been actualised in december 2020.

    Serious adverse events
    		 Overall
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 46 (30.43%)
         number of deaths (all causes)
    44
         number of deaths resulting from adverse events
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute leukaemia
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Vascular disorders
    Lymphoedema
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Cardiac disorders
    Dyspnoea
         subjects affected / exposed
    2 / 46 (4.35%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    1 / 1
    Nervous system disorders
    Cerebral oedema
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Oedema
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Subileus
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    2 / 46 (4.35%)
         occurrences causally related to treatment / all
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    Large intestinal obstruction
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Hepatic lesion
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Erythema multiforme
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Overall
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    46 / 46 (100.00%)
    Investigations
    Weight loss
         subjects affected / exposed
    7 / 46 (15.22%)
         occurrences all number
    12
    Creatinine increased
         subjects affected / exposed
    11 / 46 (23.91%)
         occurrences all number
    27
    Bilirubin increased
         subjects affected / exposed
    7 / 46 (15.22%)
         occurrences all number
    11
    Alanine aminotransferase increased
         subjects affected / exposed
    19 / 46 (41.30%)
         occurrences all number
    46
    Aspartate aminotransferase increased
         subjects affected / exposed
    23 / 46 (50.00%)
         occurrences all number
    62
    Alkaline phosphatase increased
         subjects affected / exposed
    25 / 46 (54.35%)
         occurrences all number
    66
    Gamma GT increased
         subjects affected / exposed
    21 / 46 (45.65%)
         occurrences all number
    51
    Uric acid increased
         subjects affected / exposed
    4 / 46 (8.70%)
         occurrences all number
    9
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    5 / 46 (10.87%)
         occurrences all number
    11
    Vascular disorders
    Hypertension
         subjects affected / exposed
    12 / 46 (26.09%)
         occurrences all number
    27
    Haemorrhage
         subjects affected / exposed
    6 / 46 (13.04%)
         occurrences all number
    8
    Lymphoedema
         subjects affected / exposed
    4 / 46 (8.70%)
         occurrences all number
    7
    Nervous system disorders
    Sensory neuropathy
         subjects affected / exposed
    11 / 46 (23.91%)
         occurrences all number
    28
    Headache
         subjects affected / exposed
    5 / 46 (10.87%)
         occurrences all number
    16
    Dysgeusia
         subjects affected / exposed
    4 / 46 (8.70%)
         occurrences all number
    11
    Paraesthesia
         subjects affected / exposed
    3 / 46 (6.52%)
         occurrences all number
    4
    Dizziness
         subjects affected / exposed
    3 / 46 (6.52%)
         occurrences all number
    7
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    22 / 46 (47.83%)
         occurrences all number
    60
    Neutropenia
         subjects affected / exposed
    14 / 46 (30.43%)
         occurrences all number
    35
    Lymphopenia
         subjects affected / exposed
    37 / 46 (80.43%)
         occurrences all number
    127
    Anaemia
         subjects affected / exposed
    36 / 46 (78.26%)
         occurrences all number
    100
    Thrombocytopenia
         subjects affected / exposed
    45 / 46 (97.83%)
         occurrences all number
    143
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    36 / 46 (78.26%)
         occurrences all number
    94
    Pain
         subjects affected / exposed
    19 / 46 (41.30%)
         occurrences all number
    67
    Oedema
         subjects affected / exposed
    10 / 46 (21.74%)
         occurrences all number
    21
    Oedema peripheral
         subjects affected / exposed
    3 / 46 (6.52%)
         occurrences all number
    10
    Eye disorders
    Dry eye
         subjects affected / exposed
    4 / 46 (8.70%)
         occurrences all number
    7
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    24 / 46 (52.17%)
         occurrences all number
    65
    Vomiting
         subjects affected / exposed
    17 / 46 (36.96%)
         occurrences all number
    38
    Constipation
         subjects affected / exposed
    8 / 46 (17.39%)
         occurrences all number
    23
    Diarrhoea
         subjects affected / exposed
    21 / 46 (45.65%)
         occurrences all number
    37
    Abdominal pain
         subjects affected / exposed
    16 / 46 (34.78%)
         occurrences all number
    32
    Gastrointestinal disorder
         subjects affected / exposed
    4 / 46 (8.70%)
         occurrences all number
    4
    Ascites
         subjects affected / exposed
    7 / 46 (15.22%)
         occurrences all number
    12
    Dry mouth
         subjects affected / exposed
    3 / 46 (6.52%)
         occurrences all number
    11
    Abdominal distension
         subjects affected / exposed
    6 / 46 (13.04%)
         occurrences all number
    10
    Dyspepsia
         subjects affected / exposed
    6 / 46 (13.04%)
         occurrences all number
    10
    Hemorrhoids
         subjects affected / exposed
    3 / 46 (6.52%)
         occurrences all number
    8
    Reflux gastritis
         subjects affected / exposed
    11 / 46 (23.91%)
         occurrences all number
    33
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    7 / 46 (15.22%)
         occurrences all number
    16
    Dyspnoea
         subjects affected / exposed
    11 / 46 (23.91%)
         occurrences all number
    22
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    10 / 46 (21.74%)
         occurrences all number
    27
    Anxiety
         subjects affected / exposed
    6 / 46 (13.04%)
         occurrences all number
    11
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    7 / 46 (15.22%)
         occurrences all number
    16
    Muscle contracture
         subjects affected / exposed
    4 / 46 (8.70%)
         occurrences all number
    11
    Infections and infestations
    Infection without neutropenia
         subjects affected / exposed
    3 / 46 (6.52%)
         occurrences all number
    4
    Gingivitis
         subjects affected / exposed
    3 / 46 (6.52%)
         occurrences all number
    3
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    19 / 46 (41.30%)
         occurrences all number
    46
    Hyperglycaemia
         subjects affected / exposed
    4 / 46 (8.70%)
         occurrences all number
    6
    Hyperuricaemia
         subjects affected / exposed
    11 / 46 (23.91%)
         occurrences all number
    18
    Hypoalbuminaemia
         subjects affected / exposed
    11 / 46 (23.91%)
         occurrences all number
    21
    Hypocalcaemia
         subjects affected / exposed
    5 / 46 (10.87%)
         occurrences all number
    6
    Hypokalaemia
         subjects affected / exposed
    12 / 46 (26.09%)
         occurrences all number
    18
    Hypomagnesaemia
         subjects affected / exposed
    9 / 46 (19.57%)
         occurrences all number
    15
    Hyponatraemia
         subjects affected / exposed
    5 / 46 (10.87%)
         occurrences all number
    5

    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.
    None reported
    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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