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    Clinical Trial Results:
    A proof of concept, multi-centre, clinical trial of the combination cediranib-olaparib at the time of disease progression on PARP inhibitor in ovarian cancer.

    Summary
    EudraCT number
    		 2017-001192-23
    Trial protocol
    		 ES  
    Global end of trial date
    21 Jun 2021

    Results information
    Results version number
    		 v2(current)
    This version publication date
    03 Jul 2022
    First version publication date
    20 May 2022
    Other versions
    		 v1
    Version creation reason
    • New data added to full data set
    Addition of the global end date
    Summary report(s)
    		 SMS-0388_CSR_22May2020

    Trial information

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    Trial identification
    Sponsor protocol code
    OZM-060
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02681237
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Health Network, Toronto
    Sponsor organisation address
    610 University Avenue, Toronoto, Canada, ON M5G2M9
    Public contact
    Amit Oza, Unversity Health Network, Toronto, 1 4169462818, amit.oza@uhn.ca
    Scientific contact
    Amit Oza, Unversity Health Network, Toronto, 1 4169462818, amit.oza@uhn.ca
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Interim
    Date of interim/final analysis
    22 May 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 May 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jun 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine efficacy of the combination of cediranib and olaparib in women previously receiving PARP inhibitor for ovarian cancer, with co-primary endpoints of • objective response rate by RECIST 1.1 at 8 weeks • progression-free-survival (PFS) at 16 weeks
    Protection of trial subjects
    Patient data is kept confidential throughout the whole study and physicians strive to protect the health and rights of each trial subject throughout the whole study
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Jun 2016
    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: 27
    Country: Number of subjects enrolled
    Spain: 7
    Worldwide total number of subjects
    34
    EEA total number of subjects
    7
    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)
    24
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between June 2016 and October 2018, 34 women were enrolled in two centers in Canada and Spain.

    Pre-assignment
    Screening details
    		 Women with a histologically confirmed diagnosis of recurrent ovarian, fallopian tube, or primary peritoneal cancer with high-grade serous or high-grade endometrioid histology and radiographically documented disease progression on any PARPi. Patients were required to have disease evaluable by RECIST v1.1 and amenable to a baseline biopsy.

    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
    Are arms mutually exclusive
    Yes

    Arm title
    		 Platinum sensitive
    Arm description
    		 platinum sensitive patients who had progressed on PARP and then underwent standard chemotherapy with further disease progression
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cediranib
    Investigational medicinal product code
    288383-20-0
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Cediranib to be taken orally and should be taken at the same time each day approximately. All doses should be taken with approximately 240 mL of water. The study treatment should be swallowed whole and not chewed, crushed, dissolved or divided. Tablets should be administered on an empty stomach at least 1 hour before or 2 hours after eating.

    Investigational medicinal product name
    Olaparib
    Investigational medicinal product code
    L01XX46
    Other name
    Lynparza
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Olaparib to be taken orally and should be taken at the same times each day approximately 12 hours apart. All doses should be taken with approximately 240 mL of water. The study treatment should be swallowed whole and not chewed, crushed, dissolved or divided. Tablets can be taken with a light meal/snack (e.g., two pieces of toast or a couple of biscuits).

    Arm title
    		 Platinum resistant
    Arm description
    		 platinum resistant patients who had progressed on PARP and then underwent standard chemotherapy with further disease progression
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cediranib
    Investigational medicinal product code
    288383-20-0
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Cediranib to be taken orally and should be taken at the same time each day approximately. All doses should be taken with approximately 240 mL of water. The study treatment should be swallowed whole and not chewed, crushed, dissolved or divided. Tablets should be administered on an empty stomach at least 1 hour before or 2 hours after eating.

    Investigational medicinal product name
    Olaparib
    Investigational medicinal product code
    L01XX46
    Other name
    Lynparza
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Olaparib to be taken orally and should be taken at the same times each day approximately 12 hours apart. All doses should be taken with approximately 240 mL of water. The study treatment should be swallowed whole and not chewed, crushed, dissolved or divided. Tablets can be taken with a light meal/snack (e.g., two pieces of toast or a couple of biscuits).

    Arm title
    		 Exploratory cohort
    Arm description
    		 patients whose disease had progressed on a PARPi and progressed again on subsequent standard chemotherapy, regardless of platinum sensitivity
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cediranib
    Investigational medicinal product code
    288383-20-0
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Cediranib to be taken orally and should be taken at the same time each day approximately. All doses should be taken with approximately 240 mL of water. The study treatment should be swallowed whole and not chewed, crushed, dissolved or divided. Tablets should be administered on an empty stomach at least 1 hour before or 2 hours after eating.

    Investigational medicinal product name
    Olaparib
    Investigational medicinal product code
    L01XX46
    Other name
    Lynparza
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Olaparib to be taken orally and should be taken at the same times each day approximately 12 hours apart. All doses should be taken with approximately 240 mL of water. The study treatment should be swallowed whole and not chewed, crushed, dissolved or divided. Tablets can be taken with a light meal/snack (e.g., two pieces of toast or a couple of biscuits).

    Number of subjects in period 1
    		Platinum sensitive Platinum resistant Exploratory cohort
    Started
    11
    10
    13
    Discontinued treatment
    11
    9 [1]
    11 [2]
    Still on treatment
    0 [3]
    1 [4]
    2 [5]
    Completed
    11
    10
    13
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The discontinuation of treatment in this study does not make the patient not evaluable for efficacy
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The discontinuation of treatment in this study does not make the patient not evaluable for efficacy
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The discontinuation of treatment in this study does not make the patient not evaluable for efficacy
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The discontinuation of treatment in this study does not make the patient not evaluable for efficacy
    [5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The discontinuation of treatment in this study does not make the patient not evaluable for efficacy

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Platinum sensitive
    Reporting group description
    		 platinum sensitive patients who had progressed on PARP and then underwent standard chemotherapy with further disease progression

    Reporting group title
    Platinum resistant
    Reporting group description
    		 platinum resistant patients who had progressed on PARP and then underwent standard chemotherapy with further disease progression

    Reporting group title
    Exploratory cohort
    Reporting group description
    		 patients whose disease had progressed on a PARPi and progressed again on subsequent standard chemotherapy, regardless of platinum sensitivity

    Reporting group values
    		 Platinum sensitive Platinum resistant Exploratory cohort Total
    Number of subjects
    		 11 10 13 34
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 3 2 5 10
        From 65-84 years
    		 8 8 8 24
    Gender categorical
    Units: Subjects
        Female
    		 11 10 13 34
        Male
    		 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Platinum sensitive
    Reporting group description
    		 platinum sensitive patients who had progressed on PARP and then underwent standard chemotherapy with further disease progression

    Reporting group title
    Platinum resistant
    Reporting group description
    		 platinum resistant patients who had progressed on PARP and then underwent standard chemotherapy with further disease progression

    Reporting group title
    Exploratory cohort
    Reporting group description
    		 patients whose disease had progressed on a PARPi and progressed again on subsequent standard chemotherapy, regardless of platinum sensitivity

    Primary: Objective response rate by RECIST 1.1

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    End point title
    		 Objective response rate by RECIST 1.1 [1]
    End point description
    ORR as assessed by RECIST 1.1
    End point type
    Primary
    End point timeframe
    at 8 weeks
    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 is a proof of concept study that aims to detect initial signal of efficacy with the combination cediranib/olaparib after failure on PARP inhibitor, such as olaparib. Therefore no statistical analyses are specified
    End point values
    		 Platinum sensitive Platinum resistant Exploratory cohort
    Number of subjects analysed
    11
    10
    13
    Units: number
    0
    2
    1
    No statistical analyses for this end point

    Primary: Progression Free Survival

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    End point title
    		 Progression Free Survival [2]
    End point description
    End point type
    Primary
    End point timeframe
    at 16 weeks
    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 is a proof of concept study that aims to detect initial signal of efficacy with the combination cediranib/olaparib after failure on PARP inhibitor, such as olaparib. Therefore no statistical analyses are specified
    End point values
    		 Platinum sensitive Platinum resistant Exploratory cohort
    Number of subjects analysed
    11
    10
    13
    Units: percentage
    55
    50
    39
    No statistical analyses for this end point

    Secondary: Evaluation of response rate according to CA125-GCIG criteria

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    End point title
    		 Evaluation of response rate according to CA125-GCIG criteria
    End point description
    End point type
    Secondary
    End point timeframe
    post-progression on PARP inhibitor to progression on cediranib and olaparib
    End point values
    		 Platinum sensitive Platinum resistant Exploratory cohort
    Number of subjects analysed
    11
    10
    13
    Units: number
    2
    1
    2
    No statistical analyses for this end point

    Secondary: Disease control rate

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    End point title
    		 Disease control rate
    End point description
    Disease control rate o OS will be defined by the time between randomization and the occurrence of death whatever the cause. o Response assessed by RECIST 1.1
    End point type
    Secondary
    End point timeframe
    post-progression on PARP inhibitor to progression on cediranib and olaparib
    End point values
    		 Platinum sensitive Platinum resistant Exploratory cohort
    Number of subjects analysed
    11
    10
    13
    Units: number
    9
    6
    8
    No statistical analyses for this end point

    Secondary: To evaluate the safety of the combination olaparib and cediranib

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    End point title
    		 To evaluate the safety of the combination olaparib and cediranib
    End point description
    The toxicity profile will be evaluated according to the NCI CTC AE v.4.03, AEs from grade 3/4 are added
    End point type
    Secondary
    End point timeframe
    from cycle 1 day 1 till the date of scheduled 4 weeks (+ 1 week) follow-up visit or 28 days after discontinuation of the study drug, whichever is later.
    End point values
    		 Platinum sensitive Platinum resistant Exploratory cohort
    Number of subjects analysed
    11
    10
    13
    Units: number
    23
    11
    17
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The eCRF should capture all AEs occurring from cycle 1 day 1 till the date of scheduled 4 weeks (+ 1 week) follow-up visit or 28 days after discontinuation of the study drug, whichever is later.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.03
    Reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Serious adverse events
    		 Overall trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 34 (32.35%)
         number of deaths (all causes)
    24
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Myelodysplastic syndrome
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Colonic obstruction
         subjects affected / exposed
    4 / 34 (11.76%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    2 / 34 (5.88%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Pyelonephritis
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    34 / 34 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    10 / 34 (29.41%)
         occurrences all number
    15
    General disorders and administration site conditions
    difficulty finding words
         subjects affected / exposed
    2 / 34 (5.88%)
         occurrences all number
    2
    Early satiety
         subjects affected / exposed
    4 / 34 (11.76%)
         occurrences all number
    5
    Chills
         subjects affected / exposed
    3 / 34 (8.82%)
         occurrences all number
    3
    oedema limbs
         subjects affected / exposed
    3 / 34 (8.82%)
         occurrences all number
    3
    Fatigue
         subjects affected / exposed
    17 / 34 (50.00%)
         occurrences all number
    31
    fever
         subjects affected / exposed
    4 / 34 (11.76%)
         occurrences all number
    6
    left lower quadrant pain
         subjects affected / exposed
    3 / 34 (8.82%)
         occurrences all number
    4
    shoulder pain
         subjects affected / exposed
    2 / 34 (5.88%)
         occurrences all number
    4
    Reproductive system and breast disorders
    Breast pain
         subjects affected / exposed
    3 / 34 (8.82%)
         occurrences all number
    3
    hoarseness
         subjects affected / exposed
    5 / 34 (14.71%)
         occurrences all number
    5
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 34 (17.65%)
         occurrences all number
    9
    Dyspnoea
         subjects affected / exposed
    5 / 34 (14.71%)
         occurrences all number
    7
    Epistaxis
         subjects affected / exposed
    2 / 34 (5.88%)
         occurrences all number
    4
    Nasal congestion
         subjects affected / exposed
    3 / 34 (8.82%)
         occurrences all number
    3
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    3 / 34 (8.82%)
         occurrences all number
    5
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    4 / 34 (11.76%)
         occurrences all number
    8
    Alkaline phosphatase increased
         subjects affected / exposed
    2 / 34 (5.88%)
         occurrences all number
    3
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 34 (8.82%)
         occurrences all number
    7
    Blood bilirubin increased
         subjects affected / exposed
    4 / 34 (11.76%)
         occurrences all number
    7
    Creatine urine increased
         subjects affected / exposed
    6 / 34 (17.65%)
         occurrences all number
    12
    Electrocardiogram QT prolonged
         subjects affected / exposed
    6 / 34 (17.65%)
         occurrences all number
    13
    ggt increased
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences all number
    3
    Neutrophil count decreased
         subjects affected / exposed
    8 / 34 (23.53%)
         occurrences all number
    13
    Platelet count decreased
         subjects affected / exposed
    3 / 34 (8.82%)
         occurrences all number
    13
    Weight decreased
         subjects affected / exposed
    5 / 34 (14.71%)
         occurrences all number
    5
    White blood cell count decreased
         subjects affected / exposed
    5 / 34 (14.71%)
         occurrences all number
    12
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    5 / 34 (14.71%)
         occurrences all number
    7
    Dysgeusia
         subjects affected / exposed
    4 / 34 (11.76%)
         occurrences all number
    4
    Headache
         subjects affected / exposed
    8 / 34 (23.53%)
         occurrences all number
    8
    Peripheral sensory neuropathy
         subjects affected / exposed
    2 / 34 (5.88%)
         occurrences all number
    4
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    6 / 34 (17.65%)
         occurrences all number
    23
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    14 / 34 (41.18%)
         occurrences all number
    25
    bloating
         subjects affected / exposed
    5 / 34 (14.71%)
         occurrences all number
    7
    colonic obstruction
         subjects affected / exposed
    3 / 34 (8.82%)
         occurrences all number
    4
    Constipation
         subjects affected / exposed
    6 / 34 (17.65%)
         occurrences all number
    8
    Diarrhoea
         subjects affected / exposed
    24 / 34 (70.59%)
         occurrences all number
    40
    Dry mouth
         subjects affected / exposed
    2 / 34 (5.88%)
         occurrences all number
    2
    Dyspepsia
         subjects affected / exposed
    4 / 34 (11.76%)
         occurrences all number
    4
    Gingival pain
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences all number
    3
    mucositis oral
         subjects affected / exposed
    5 / 34 (14.71%)
         occurrences all number
    6
    Nausea
         subjects affected / exposed
    22 / 34 (64.71%)
         occurrences all number
    27
    Rectal haemorrhage
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences all number
    2
    Vomiting
         subjects affected / exposed
    20 / 34 (58.82%)
         occurrences all number
    35
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    6 / 34 (17.65%)
         occurrences all number
    9
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    4 / 34 (11.76%)
         occurrences all number
    4
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences all number
    3
    Back pain
         subjects affected / exposed
    3 / 34 (8.82%)
         occurrences all number
    3
    Generalized muscle weakness
         subjects affected / exposed
    7 / 34 (20.59%)
         occurrences all number
    14
    Myalgia
         subjects affected / exposed
    2 / 34 (5.88%)
         occurrences all number
    5
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 34 (8.82%)
         occurrences all number
    4
    Urinary tract infection
         subjects affected / exposed
    7 / 34 (20.59%)
         occurrences all number
    9
    Metabolism and nutrition disorders
    Anorexia nervosa
         subjects affected / exposed
    10 / 34 (29.41%)
         occurrences all number
    12
    Dehydration
         subjects affected / exposed
    3 / 34 (8.82%)
         occurrences all number
    6
    Hypomagnesaemia
         subjects affected / exposed
    4 / 34 (11.76%)
         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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/32444417
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