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    Clinical Trial Results:
    Effect of the moderate CYP3A4-inhibitor erythromycin on the pharmacokinetics of palbociclib

    Summary
    EudraCT number
    		 2018-004032-29
    Trial protocol
    		 NL  
    Global end of trial date
    10 May 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Jul 2022
    First version publication date
    24 Jul 2022
    Other versions
    Summary report(s)
    		 Publication CLINICAL PHARMACOLOGY & THERAPEUTICS: Effects of the Moderate CYP3A4 Inhibitor Erythromycin on the Pharmacokinetics of Palbociclib

    Trial information

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    Trial identification
    Sponsor protocol code
    M18CYP
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
    Sponsor organisation address
    Plesmanlaan 121, Amsterdam, Netherlands,
    Public contact
    Neeltje Steeghs, The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, n.steeghs@nki.nl
    Scientific contact
    Neeltje Steeghs, The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, n.steeghs@nki.nl
    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
    12 Jul 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 May 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    10 May 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this trial is to study the effect of the moderate CYP3A4 inhibitor erythromycin on the pharmacokinetics of palbociclib, measured as AUC0-24h, Cmax and Cmin.
    Protection of trial subjects
    Theoretically, the concomitant administration of palbociclib with erythromycin could lead to higher palbociclib exposure and thus give an increased risk of toxicities. However, the duration of this intervention is short (7 days). Although erythromycin rarely gives toxicities, this is a minor risk for patients. Since erythromycin could prolong the QTc interval, an ECG will be performed at screening. Patients with a prolonged QTc interval will be excluded.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Dec 2018
    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
    Netherlands: 12
    Worldwide total number of subjects
    12
    EEA total number of subjects
    12
    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)
    8
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Patients with histological or cytological proof of cancer with an indicationfor treatment with palbociclib (i.e., advanced breast cancer) at the standard dose of 125 mg q.d. were eligible for inclusion. Further inclusion criteria were aged ≥18 years, World Health Organization performance status of 0, 1, or 2, and adequate organ function.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A
    Arm description
    		 start with either palbociclib 125 mg q.d. combined with erythromycin 500 mg three times daily (t.i.d.) and then crossover to palbociclib monotherapy 125 mg q.d.
    Arm type
    		 Experimental

    Investigational medicinal product name
    palbociclib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients were randomized to start with either palbociclib 125 mg q.d. combined with erythromycin 500 mg three times daily (t.i.d.) and then crossover to palbociclib monotherapy 125 mg q.d.

    Investigational medicinal product name
    Erythromycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients were randomized to start with either palbociclib 125 mg q.d. combined with erythromycin 500 mg three times daily (t.i.d.) and then crossover to palbociclib monotherapy 125 mg q.d.

    Arm title
    		 Arm B
    Arm description
    		 Start with palbociclib monotherapy 125 mg q.d. and then crossover to palbociclib 125 mg q.d. combined with erythromycin 500 mg three times daily (t.i.d.)
    Arm type
    		 Experimental

    Investigational medicinal product name
    palbociclib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Start with palbociclib monotherapy 125 mg q.d. and then crossover to palbociclib 125 mg q.d. combined with erythromycin 500 mg three times daily (t.i.d.)

    Investigational medicinal product name
    Erythromycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Start with palbociclib monotherapy 125 mg q.d. and then crossover to palbociclib 125 mg q.d. combined with erythromycin 500 mg three times daily (t.i.d.)

    Number of subjects in period 1
    		Arm A Arm B
    Started
    6
    6
    Completed
    6
    5
    Not completed
    0
    1
         Consent withdrawn by subject
    -
    1

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 start with either palbociclib 125 mg q.d. combined with erythromycin 500 mg three times daily (t.i.d.) and then crossover to palbociclib monotherapy 125 mg q.d.

    Reporting group title
    Arm B
    Reporting group description
    		 Start with palbociclib monotherapy 125 mg q.d. and then crossover to palbociclib 125 mg q.d. combined with erythromycin 500 mg three times daily (t.i.d.)

    Primary: Pharmacokinetics

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    End point title
    		 Pharmacokinetics [1]
    End point description
    To study the effect of the moderate CYP3A4 inhibitor erythromycin on the pharmacokinetics of palbociclib, measured as AUC0-24h, Cmax and Cmin.
    End point type
    Primary
    End point timeframe
    At Day 7 and Day 21 , patients were admitted and blood samples were collected for pharmacokinetic analyses. Timepoints were before dosing (directly before ingestion of palbociclib) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and 24 hrs post dosing
    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: See table 2 of publication attached
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    6
    5
    Units: ng/mL and ng*h/mL
        number (not applicable)
    6
    5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events should be collected beginning from the time the patient starts the study treatment (Day 1) and ending with end of the study (Day 21).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTC
    Dictionary version
    5.0
    Frequency threshold for reporting non-serious adverse events: 1%
    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: See table 3 of publication attached.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Jan 2019
    Erasmus Medical Center added as trial center
    08 Dec 2020
    Change # evaluable patients to 11 patients.

    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
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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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