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    Clinical Trial Results:
    A single arm, open-label, phase II study to assess the efficacy of rucaparib in metastatic breast cancer patients with a BRCAness genomic signature.

    Summary
    EudraCT number
    2015-000580-14
    Trial protocol
    FR  
    Global end of trial date
    09 Jan 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    01 Mar 2022
    First version publication date
    01 Mar 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    UC-0105/1501
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02505048
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UNICANCER
    Sponsor organisation address
    101 rue de Tolbiac, Paris, France, 75013
    Public contact
    Nourredine AIT-RAHMOUNE, UNICANCER, 33 1 71 93 67 04, n.ait-rahmoune@unicancer.fr
    Scientific contact
    Nourredine AIT-RAHMOUNE, UNICANCER, 33 1 71 93 67 04, n.ait-rahmoune@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
    26 Mar 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Jan 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to assess the clinical benefit rate (CBR) of rucaparib in previously treated metastatic breast cancer patients with a BRCAness profile or a BRCA1/2 somatic mutation, and if significant, to assess the overall response rate (ORR).
    Protection of trial subjects
    An Independent Ethics Committees reviewed and gave a favorable opinion to the study documents, including the initial protocol and all subsequent amendments, and all information and documents provided to subjects/patients. This study was conducted in accordance with: * The Declaration of Helsinki (1964) and subsequent amendments * The Good Clinical Practices defined by the International Conference on Harmonization (ICH–E6, 17/07/96 * The European Directive (2001/20/CE) * The Huriet’s law (n° 88-1138) of December 20th, 1988, relative to the protection of persons participating in biomedical research and modified by the Public Health Law n°2004-806 of August 9th, 2004, * The law on ‘informatics and freedom’ (Informatique et Libertés n° 78-17) of January 6th,1978 modified by the law n° 2004-801 of August 6th, 2004 relative to the protection of persons with regard to the computerized processing of personal data * The bioethic law n°2011-814 of July 8, 2011.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    25 Aug 2015
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety, Efficacy
    Long term follow-up duration
    2 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 40
    Worldwide total number of subjects
    40
    EEA total number of subjects
    40
    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)
    29
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    RUBY was a single arm, open-label, multicentric, phase II trial assessing the efficacy of the PARP inhibitor rucaparib. Patients had HER2 negative, BRCAness profile defined by Clovis genomic signature or BRCA1/2 somatic mutation, progressing breast cancer with at least one line of chemotherapy at the metastatic setting.

    Pre-assignment
    Screening details
    The study consisted of a 28-day screening phase to establish patients' eligibility and document baseline measurements, a treatment phase (28-day treatment cycles until disease progression), and a long-term follow-up to monitor the clinical benefit rate, progression-free survival, overall survival, and the prognostic value of the Clovis signature.

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

    Arms
    Arm title
    Rucaparib
    Arm description
    All eligible patients entering the study received rucaparib (600 mg oral) twice daily, every day in 28-day cycles until patient withdrawal (toxicity, disease progression, or after patient’s or investigator’s decision).
    Arm type
    Experimental

    Investigational medicinal product name
    Rucaparib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All eligible patients received 600 mg oral rucaparib (2 x 300 mg tablets) twice daily, every day in 28-day cycles until toxicity, disease progression, or patient’s or investigator’s decision. Tablets should have been swallowed with at least 240 mL of water at the same time each morning, and evening without regards to meals.

    Number of subjects in period 1
    Rucaparib
    Started
    40
    Completed
    3
    Not completed
    37
         Death
    34
         Sponsor decision
    3

    Baseline characteristics

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

    Reporting group values
    Overall period Total
    Number of subjects
    40 40
    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)
    29 29
        From 65-84 years
    11 11
        85 years and over
    0 0
    Age continuous
    Units: years
        median (full range (min-max))
    54 (27 to 76) -
    Gender categorical
    Units: Subjects
        Female
    40 40
        Male
    0 0
    Eastern Cooperative Oncology Group Performance status
    Units: Subjects
        ECOG 0
    23 23
        ECOG 1
    17 17
    Primary tumor phenotype
    Units: Subjects
        ER-/PR-
    17 17
        ER-/PR+
    1 1
        ER+/PR-
    3 3
        ER+/PR+
    19 19
    Number of previous chemotherapy received in the metastatic setting
    Units: Subjects
        01
    17 17
        02
    6 6
        03
    11 11
        04
    4 4
        05
    1 1
        06
    1 1
    Previous platinuum salts (all settings)
    Units: Subjects
        Yes
    10 10
        No
    30 30

    End points

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    End points reporting groups
    Reporting group title
    Rucaparib
    Reporting group description
    All eligible patients entering the study received rucaparib (600 mg oral) twice daily, every day in 28-day cycles until patient withdrawal (toxicity, disease progression, or after patient’s or investigator’s decision).

    Primary: Clinical benefice rate

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    End point title
    Clinical benefice rate [1]
    End point description
    End point type
    Primary
    End point timeframe
    DIsease evolution was assessed every 8 weeks until disease progression (up to 30 moths) according to RECIST evaluation.
    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: The primary endpoint was the clinical benefice rate. The decision rule was that least 11 of 37 evaluable patients were required to achieve a clinical response in order to claim for the success of the study.
    End point values
    Rucaparib
    Number of subjects analysed
    37
    Units: percent
        number (confidence interval 95%)
    13.5 (4.5 to 28.8)
    No statistical analyses for this end point

    Secondary: Progression-free survival

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    End point title
    Progression-free survival
    End point description
    The Progression free survival was defined as the time from first dose of rucaparib to the disease progression assessed by RECIST or death from any cause. Patients still alive at the time of analysis without documented progression were censored at the last tumor assessment.
    End point type
    Secondary
    End point timeframe
    30 months
    End point values
    Rucaparib
    Number of subjects analysed
    37
    Units: month
        median (confidence interval 95%)
    1.7 (1.4 to 1.8)
    No statistical analyses for this end point

    Secondary: Overall survival

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    End point title
    Overall survival
    End point description
    The Overall survival was defined as the delay between the date of inclusion to death from any cause. Patients still alive at the time of analysis (including lost to follow-up) were censored at the last known alive date.
    End point type
    Secondary
    End point timeframe
    30 months
    End point values
    Rucaparib
    Number of subjects analysed
    37
    Units: month
        median (confidence interval 95%)
    6.7 (5.6 to 12.5)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall period of the study (up to 30 months after first study medication intake)
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Rucaparib
    Reporting group description
    -

    Serious adverse events
    Rucaparib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 40 (30.00%)
         number of deaths (all causes)
    34
         number of deaths resulting from adverse events
    0
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumor progression
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 40 (10.00%)
         occurrences causally related to treatment / all
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    General physical health deterioration
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bone pain aggravated
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Device related infection
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 40 (2.50%)
         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
    Rucaparib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    40 / 40 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    5
    Lymphoedema
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    5
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    16 / 40 (40.00%)
         occurrences all number
    29
    Aspartate aminotransferase increased
         subjects affected / exposed
    25 / 40 (62.50%)
         occurrences all number
    44
    Blood alkaline phosphatase increased
         subjects affected / exposed
    13 / 40 (32.50%)
         occurrences all number
    20
    Blood bilirubin increased
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    3
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    23 / 40 (57.50%)
         occurrences all number
    37
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    6 / 40 (15.00%)
         occurrences all number
    8
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    15 / 40 (37.50%)
         occurrences all number
    22
    Leukopenia
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    3
    Lymphopenia
         subjects affected / exposed
    15 / 40 (37.50%)
         occurrences all number
    34
    Neutropenia
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    3
    Thrombocytopenia
         subjects affected / exposed
    7 / 40 (17.50%)
         occurrences all number
    12
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    3
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    28 / 40 (70.00%)
         occurrences all number
    56
    Chest pain
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    5
    Pain
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    7
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Insomnia
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    4 / 40 (10.00%)
         occurrences all number
    4
    Constipation
         subjects affected / exposed
    6 / 40 (15.00%)
         occurrences all number
    7
    Nausea
         subjects affected / exposed
    8 / 40 (20.00%)
         occurrences all number
    11
    Vomiting
         subjects affected / exposed
    5 / 40 (12.50%)
         occurrences all number
    8
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Bone pain
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    4
    Myalgia
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    7
    Pain in extremity
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    3
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    6 / 40 (15.00%)
         occurrences all number
    7
    Hypercholesterolaemia
         subjects affected / exposed
    8 / 40 (20.00%)
         occurrences all number
    13
    Hyperglycaemia
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Jun 2015
    Following the request of the competent authority (ANSM), the sponsor modified the information relative to contraception in the protocol and the patient consent form. A serum pregnancy test was requested before initiation of all treatment cycles. Hormonal contraception were excluded due to potential interactions with rucaparib.
    17 Jul 2015
    * The protocol was modified to specifiy the link between SAFIR02 and RUBY studies. Patients not eligible to randomization in the SAFIR02 study (but meeting all the inclusion/exclusion criteria of the RUBY study) may be included. * Rucaparib in 120 mg tablets were replaced by 200 mg tablets, the first step of the dose modification strategy was modified and the third level of dose reduction implemented to be consistent with other clinical trilas using rucaparib montherapy 600 mg b.i.d, every day in 28-day cycles.
    30 Jun 2016
    * Patients were allowed to take 2 x 300mg tablets or 3 x 200 mg tablets. * Patient who consented to participate to the ancillary study were asked for blood samples. The volume of blood collected was reduced from 30 mL to 20 mL in "Streck” tubes instead of EDTA tubes. * An independent committee of radiologist was implemented to confirm the investigator radiological-based assessment of rucaparib efficacy. * The safety section of the protocol was amended following publication of the version7 of rucaparib’s investigator brochure. Particular attention of grade 3 cholesterol increase was recommended. Also, warning were introduced regarding drug-drug interaction between rucaparib and statins. This modification impacted the collection of SAE by the pharmacovigilance unit at UNICANCER. *Following the publication of the version 7 of rucaparib’s investigator brochure, myelodysplastic syndrome and acute myeloid leukemia were considered adverse events of special interest.

    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.
    Limitations of the trial are the small number of subjects analysed, the lack of comparison (single arm study) of rucaparib with usual chemotherapy in patients with high genomic instability associated with poor outcome.
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