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    Clinical Trial Results:
    CATCH-R: A Rollover Study to Provide Continued Access to Clinical Therapy with Rucaparib

    Summary
    EudraCT number
    		 2020-001538-37
    Trial protocol
    		 CZ   HU   PL   ES   IT  
    Global end of trial date
    08 Mar 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Jun 2024
    First version publication date
    09 Jun 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CO-338-111
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04676334
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    pharmaand GmbH
    Sponsor organisation address
    Taborstraße 1, Wien, Austria, 1020
    Public contact
    Medical Information Department pharmaand GmbH, pharmaand GmbH, +43 13560006, medinfo@pharmaand.com
    Scientific contact
    Medical Information Department pharmaand GmbH, pharmaand GmbH, +43 13560006, medinfo@pharmaand.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    08 Mar 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Mar 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This protocol is designed to provide participants currently benefiting from rucaparib treatment in a Clovis-sponsored clinical study (2013-000517-20; 2013-000518-39; 2016-000816-14; 2016-003162-13) with continued access to treatment for as long as they continue to benefit. Participants in long-term follow-up (LTFU) in a parent study (2016-000816-14) may also enroll in this study for continued data collection, as applicable based on parent study objectives.
    Protection of trial subjects
    The study was performed in compliance with the Declaration of Helsinki, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, and regulatory requirements as applicable.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Apr 2021
    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
    Brazil: 10
    Country: Number of subjects enrolled
    Czechia: 2
    Country: Number of subjects enrolled
    Hungary: 2
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    Canada: 7
    Country: Number of subjects enrolled
    Israel: 2
    Country: Number of subjects enrolled
    Russian Federation: 8
    Country: Number of subjects enrolled
    Italy: 2
    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)
    28
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Only serious adverse event (SAE) and adverse event of special interest (AESI) safety data were collected, Other (non-serious) adverse events (AEs) were not collected.

    Pre-assignment
    Screening details
    		 Safety data were collected only for the Rucaparib arm (participants who received rucaparib during this study); safety data were not collected for the Long-term Follow-up arm (participants who did not receive rucaparib during this study).

    Period 1
    Period 1 title
    Overall Study (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
    		 Rucaparib
    Arm description
    		 Participants received rucaparib at a dose and schedule last taken in the parent study, or per investigator decision.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rucaparib
    Investigational medicinal product code
    Other name
    CO-338, Rubraca
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Rucaparib was administered daily.

    Arm title
    		 Long-term Follow-up
    Arm description
    		 Participants discontinued rucaparib treatment and were in long-term follow-up in the parent study.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Rucaparib Long-term Follow-up
    Started
    20
    14
    Received at Least 1 Dose of Study Drug
    20
    0 [1]
    Completed
    20
    14
    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: No study drug was administered to the Long-term Follow-up arm.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Rucaparib
    Reporting group description
    		 Participants received rucaparib at a dose and schedule last taken in the parent study, or per investigator decision.

    Reporting group title
    Long-term Follow-up
    Reporting group description
    		 Participants discontinued rucaparib treatment and were in long-term follow-up in the parent study.

    Reporting group values
    		 Rucaparib Long-term Follow-up Total
    Number of subjects
    		 20 14 34
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 17 11 28
        From 65-84 years
    		 3 3 6
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59.2 ( 8.92 ) 60.5 ( 7.04 ) -
    Gender categorical
    Units: Subjects
        Female
    		 19 14 33
        Male
    		 1 0 1
    Ethnicity (NIH/OMB)
    NIH/OMB: National Institutes of Health/Office of Management and Budget
    Units: Subjects
        Hispanic or Latino
    		 3 4 7
        Not Hispanic or Latino
    		 17 9 26
        Unknown or Not Reported
    		 0 1 1
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 2 2
        White
    		 20 12 32
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Rucaparib
    Reporting group description
    		 Participants received rucaparib at a dose and schedule last taken in the parent study, or per investigator decision.

    Reporting group title
    Long-term Follow-up
    Reporting group description
    		 Participants discontinued rucaparib treatment and were in long-term follow-up in the parent study.

    Subject analysis set title
    Enrolled Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Enrolled Population: all participants who were enrolled in the study.

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety Population: all participants who received rucaparib during the study (Rucaparib arm), safety data were not collected for the Long-term Follow-up arm.

    Primary: Number of Participants Experiencing SAEs and AESIs

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    End point title
    		 Number of Participants Experiencing SAEs and AESIs [1] [2]
    End point description
    An SAE was any untoward medical occurrence that occurred at any dose, or after informed consent was given and prior to dosing if the SAE was related to a study procedure, that: resulted in death; was life-threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly or birth defect; or was an important medical event that may not have resulted in death, was not life-threatening, or did not require hospitalization but may be considered an SAE, based on appropriate medical judgment. An AESI was defined as any AE of scientific and medical concern specific to the sponsor’s product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate. A summary of all SAEs regardless of causality is located in the ‘Adverse events’ Section.
    End point type
    Primary
    End point timeframe
    From first dose of rucaparib through 28 days after receiving last dose of rucaparib (approximately 20 months)
    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: Only the number of participants was collected for this end point.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Safety data were collected only for the Rucaparib arm (participants who received rucaparib during this study); safety data were not collected for the Long-term Follow-up arm (participants who did not receive rucaparib during this study).
    End point values
    		 Rucaparib
    Number of subjects analysed
    20 [3]
    Units: Participants
        SAEs
    2
        AESIs
    0
    Notes
    [3] - Safety Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From first dose of rucaparib through 28 days after receiving last dose of rucaparib (approximately 20 months)
    Adverse event reporting additional description
    Only SAE and AESI safety data were collected, Other (non-serious) AEs were not collected. Safety data were collected only for the Rucaparib arm; safety data were not collected for the Long-term Follow-up arm. Data reported for Safety Population: all participants who received rucaparib during the study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Rucaparib
    Reporting group description
    		 Participants received rucaparib at a dose and schedule last taken in the parent study, or per investigator decision.

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Only SAE and AESI safety data were collected, Other (non-serious) AEs were not collected. Safety data were collected only for the Rucaparib arm (participants who received rucaparib during this study); safety data were not collected for the Long-term Follow-up arm (participants who did not receive rucaparib during this study).
    Serious adverse events
    		 Rucaparib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 20 (10.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Rucaparib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)

    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.
    Only SAE and AESI safety data were collected, Other (non-serious) AEs were not collected. Safety data were collected only for the Rucaparib arm; safety data were not collected for the Long-term Follow-up arm.
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    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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