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    Clinical Trial Results:
    Nab-Paclitaxel (Abraxane®) and Gemcitabine as first line therapy in patients with cholangiocarcinoma ineligible for cisplatin-based chemotherapy – a pilot study The NACHO trial (GEMNABCCC-001)

    Summary
    EudraCT number
    		 2014-004981-52
    Trial protocol
    		 DE  
    Global end of trial date
    10 Oct 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Aug 2022
    First version publication date
    15 Aug 2022
    Other versions
    Summary report(s)
    		 CSR_2014-004981-52

    Trial information

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    Trial identification
    Sponsor protocol code
    GEMNABCCC-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 AX-CL-OTHER-PI-003916 : Celgene number
    Sponsors
    Sponsor organisation name
    University Hospital Essen
    Sponsor organisation address
    Hufelandstr. 55, Essen, Germany, 45147
    Public contact
    PI, University Hospital Essen, +49 02017231791, gabriele.linden@uk-essen.de
    Scientific contact
    PI, University Hospital Essen, +49 02017231791, gabriele.linden@uk-essen.de
    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
    01 Jul 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Oct 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Oct 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary objective: To determine the efficacy of Gemcitabine/nab-Paclitaxel in first-line therapy of patients with cholangiocarcinoma ineligible for Cisplatin-based therapy. Results of the first 10 evaluable patients will be compared to patient outcomes from the cancer registry of the West German Cancer Center (patients treated with Gemcitabine-combinations, patients treated with monotherapies). Primary endpoint will be overall response rate (ORR) (complete remission and partial remission)
    Protection of trial subjects
    AE were measured at every visit. The regulatory basis of the conduct of this study consisted of the Declaration of Helsinki (in its current version), the AMG [German Medicinal Products Act], in particular Sections 40-42 in the current versions, the guidelines of Good Clinical Practice (ICH-GCP: International Conference on Harmonisation –Good Clinical Practice) valid since 17-Jan-1997, and the GCP-regulation of 09-Aug-2004 (last change of 15-Mar-2006).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Jan 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
    Germany: 10
    Worldwide total number of subjects
    10
    EEA total number of subjects
    10
    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)
    7
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment 06.Dec2016 - 05.Jul 2017

    Pre-assignment
    Screening details
    		 all screened patients were registered. in total, 10 patients started therapy. There was no screen failure

    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
    		 Nab-Paclitaxel and Gemcitabine
    Arm description
    		 Nab-Paclitaxel (Abraxane®) and Gemcitabine
    Arm type
    		 Experimental

    Investigational medicinal product name
    nab-paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Nab-Paclitaxel (Abraxane®) 125mg/m² i.v. day 1, 8, 15 for patients with bilirubin 1.5-3ULN Nab-Paclitaxel (Abraxane®) 100mg/m² i.v. day 1, 8, 15

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Gemcitabine 1000mg/m² i.v. day 1, 8, 15 repeat the cycle at day 28, until disease progression For Patients with elevated bilirubin values >1.5-3x ULN): Gemcitabine 800mg/m² i.v. day 1, 8, 15

    Number of subjects in period 1
    		Nab-Paclitaxel and Gemcitabine
    Started
    10
    Completed
    10

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Nab-Paclitaxel and Gemcitabine
    Reporting group description
    		 Nab-Paclitaxel (Abraxane®) and Gemcitabine

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention-To-treat population

    Primary: Objective Response Rate (ORR)

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    End point title
    		 Objective Response Rate (ORR) [1]
    End point description
    Altogether 10 patients were enrolled into the trial and received at least one cycle of chemotherapy (ITT-population), In total 4 of the ITT set had CR or PR as best response; this amounted to an ORR of 40%. DCR (CR+PR+SD) was 80%.
    End point type
    Primary
    End point timeframe
    Registration to EOS
    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 full data set
    End point values
    		 ITT
    Number of subjects analysed
    10
    Units: 4
        number (not applicable)
    10
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Screening to EOS
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    3.0
    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 full data set

    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
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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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