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    Clinical Trial Results:
    A Phase 1/2 Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Weekly Doses of Palifermin (Recombinant Human Keratinocyte Growth Factor, rHuKGF) for the Reduction of Oral Mucositis in Subjects with Locally Advanced Head and Neck Cancer (HNC) Receiving Postoperative Radiotherapy with Concurrent Chemotherapy

    Summary
    EudraCT number
    		 2004-001716-31
    Trial protocol
    		 DE  
    Global end of trial date
    28 Jul 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 May 2017
    First version publication date
    26 May 2017
    Other versions
    Summary report(s)
    		 20040124 CSR synopsis LTFU

    Trial information

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    Trial identification
    Sponsor protocol code
    20040124
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00626639
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Swedish Orphan Biovitrum AB
    Sponsor organisation address
    KISP, Stockholm, Sweden, 11276
    Public contact
    Medical Information, Swedish Orphan Biovitrum AB, 46 86972000, info@sobi.com
    Scientific contact
    Medical Information, Swedish Orphan Biovitrum AB, 46 86972000, info@sobi.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
    28 Jul 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Jul 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Jul 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the pharmacokinetic profile and biological activity on buccal mucosae of palifermin administered at the dose of 120 μg/kg IV in a cohort of at least 16 (3 palifermin : 1 placebo) locally advanced HNC subjects receiving RT with concurrent CT as adjuvant treatment for their disease (post-operative setting). To evaluate the safety and tolerability of palifermin when administered at the dose of 120 μg/kg weekly for up to 8 consecutive weeks to patients with locally advanced HNC receiving RT with concurrent CT as adjuvant treatment for their disease (post-operative setting).
    Protection of trial subjects
    This study was conducted in accordance with FDA and International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) regulations/guidelines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Jul 2005
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 5
    Worldwide total number of subjects
    5
    EEA total number of subjects
    5
    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)
    3
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at one site in Germany. 5 subjects were randomized to the acute phase of the study. The plan was to enroll 40 subjects but the study was closed due to administrative changes at the site and slow enrollment. After the acute phase of the study (Period 1) the study continued with a long term follow-up phase (Period 2).

    Pre-assignment
    Screening details
    		 Subjects ≥18 years of age with newly diagnosed histologically confirmed squamous cell carcinoma involving either the oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx, post surgical resection (R0, R1) and who were candidates for adjuvant RT/CT were eligible for enrollment.

    Period 1
    Period 1 title
    Acute phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Eligible subjects were randomized by calling an Interactive Voice Response System (IVRS) within 24 hours before the first dose of investigational product. They were randomized in a 3:1 ratio (palifermin:placebo) in PK/PD/BMD cohort and 1:1 ratio (palifermin:placebo) in the other cohort, and stratified by post surgical residual tumor stage to receive either one dose of placebo or palifermin on day –3 prior to start of CT/RT then once weekly prior to onset of grade ≥3 OM (maximum 8 doses).

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo was given as intravenous bolus injections.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.

    Arm title
    		 Palifermin
    Arm description
    		 Palifermin was given as intravenous bolus injections.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Palifermin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.

    Number of subjects in period 1
    		Placebo Palifermin
    Started
    2
    3
    Completed
    2
    2
    Not completed
    0
    1
         Adverse event, serious fatal
    -
    1
    Period 2
    Period 2 title
    Long-term follow up
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Palifermin
    Arm description
    		 Subjects who received palifermin during the active phase of the study.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Placebo
    Arm description
    		 Subjects who received placeboduring the active phase of the study.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Palifermin Placebo
    Started
    2
    2
    Completed
    1
    0
    Not completed
    1
    2
         Adverse event, serious fatal
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo was given as intravenous bolus injections.

    Reporting group title
    Palifermin
    Reporting group description
    		 Palifermin was given as intravenous bolus injections.

    Reporting group values
    		 Placebo Palifermin Total
    Number of subjects
    		 2 3 5
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 1 2 3
        From 65-84 years
    		 1 1 2
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0
        Male
    		 2 3 5
    Subject analysis sets

    Subject analysis set title
    Placebo - safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects receiving at least one dose of IMP (placebo) in the in the active phase

    Subject analysis set title
    Palifermin - safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects receiving at least one dose of IMP (palifermin) in the in the active phase

    Subject analysis set title
    Palifermin - per protocol set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects who received all 8 investigational product doses (palifermin).

    Subject analysis set title
    Palifermin - LTFU analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects who received palifermin during the active phase of the study and were followed in the long term follow up phase.

    Subject analysis set title
    Placebo - LTFU analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects who received placebo during the active phase of the study and were followed in the long term follow-up phase.

    Subject analysis sets values
    		 Placebo - safety analysis set Palifermin - safety analysis set Palifermin - per protocol set Palifermin - LTFU analysis set Placebo - LTFU analysis set
    Number of subjects
    2
    3
    1
    2
    2
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    1
    2
    0
    1
    1
        From 65-84 years
    1
    1
    1
    1
    1
    Age continuous
    Units:
        
    ( )
    ( )
    ( )
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    0
    0
    0
    0
    0
        Male
    2
    3
    1
    2
    2

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo was given as intravenous bolus injections.

    Reporting group title
    Palifermin
    Reporting group description
    		 Palifermin was given as intravenous bolus injections.
    Reporting group title
    Palifermin
    Reporting group description
    		 Subjects who received palifermin during the active phase of the study.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects who received placeboduring the active phase of the study.

    Subject analysis set title
    Placebo - safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects receiving at least one dose of IMP (placebo) in the in the active phase

    Subject analysis set title
    Palifermin - safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects receiving at least one dose of IMP (palifermin) in the in the active phase

    Subject analysis set title
    Palifermin - per protocol set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects who received all 8 investigational product doses (palifermin).

    Subject analysis set title
    Palifermin - LTFU analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects who received palifermin during the active phase of the study and were followed in the long term follow up phase.

    Subject analysis set title
    Placebo - LTFU analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects who received placebo during the active phase of the study and were followed in the long term follow-up phase.

    Primary: Buccal mucosal cell proliferation assayed by staining for cell cycle proliferation marker Ki67.

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    End point title
    		 Buccal mucosal cell proliferation assayed by staining for cell cycle proliferation marker Ki67. [1]
    End point description
    The effect of palifermin on cell proliferation was to be assayed by staining for the cell cycle proliferation marker Ki67 in buccal mucosal biopsy samples taken prior to the first dose and either 24 or 48 hours after the first dose. Due to the small sample size, this analysis was not performed.
    End point type
    Primary
    End point timeframe
    Day -3 predose and 24 or 48 hours post-dose
    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: Due to the small sample size no analysis was performed on the primary endpoint.
    End point values
    		 Placebo Palifermin
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: number
    Notes
    [2] - Due to the small sample size these analyses were not performed.
    [3] - Due to the small sample size these analyses were not performed.
    No statistical analyses for this end point

    Secondary: Pharmacokinetics of Palifermin

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    End point title
    		 Pharmacokinetics of Palifermin
    End point description
    The following PK secondary endpoints were to be considered, but due to the small sample size the analyses were not performed: PK endpoints will include, but are not limited to: systemic clearance (CL), volume of distribution at steady state (Vss), estimated initial concentration (C0), area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC(0-t)) and to infinity (AUC(0-∞)), terminal half-life (t1/2,z), mean residence time (MRT).
    End point type
    Secondary
    End point timeframe
    Day -3, predose and at 2, 5, 15, 30, 60, and 90 minutes and 2, 4, 6, 8, 10, 12, 24 and 48 hours after the first dose
    End point values
    		 Placebo - safety analysis set Palifermin - safety analysis set
    Number of subjects analysed
    0 [4]
    0 [5]
    Units: number
    Notes
    [4] - Due to the small sample size these analyses were not performed.
    [5] - Due to the small sample size these analyses were not performed.
    No statistical analyses for this end point

    Secondary: Pharmacodynamics of Palifermin

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    End point title
    		 Pharmacodynamics of Palifermin
    End point description
    The following PD secondary endpoints were to be considered, but due to the small sample size of only 5 subjects the analyses were not performed: Cell proliferation, Apoptosis, Cell differentiation, Expression of de-toxifying enzymes involved in oxidative stress, Expression of KGF receptor.
    End point type
    Secondary
    End point timeframe
    Day -3 predose and 24 or 48 hours post-dose.
    End point values
    		 Placebo - safety analysis set Palifermin - safety analysis set
    Number of subjects analysed
    0 [6]
    0 [7]
    Units: number
    Notes
    [6] - Due to the small sample size these analyses were not performed
    [7] - Due to the small sample size these analyses were not performed
    No statistical analyses for this end point

    Secondary: Acute phase Efficay and Safety endpoints

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    End point title
    		 Acute phase Efficay and Safety endpoints
    End point description
    Due to the small sample size these analyses ware not performed.
    End point type
    Secondary
    End point timeframe
    From baseline until week 12
    End point values
    		 Placebo - safety analysis set Palifermin - safety analysis set
    Number of subjects analysed
    0 [8]
    0 [9]
    Units: number
    Notes
    [8] - Due to the small sample size these analyses were not performed.
    [9] - Due to the small sample size these analyses were not performed.
    No statistical analyses for this end point

    Secondary: Progression or Recurrence of Primary Disease During Long-Term Follow-up

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    End point title
    		 Progression or Recurrence of Primary Disease During Long-Term Follow-up
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline until death, lost to follow up or study end
    End point values
    		 Palifermin - LTFU analysis set Placebo - LTFU analysis set
    Number of subjects analysed
    2
    2
    Units: Subjects
    1
    1
    No statistical analyses for this end point

    Secondary: Second Primary Tumor, Other Malignancy, Lost to Follow-up, or Leukoplakia During Long-Term Follow-up

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    End point title
    		 Second Primary Tumor, Other Malignancy, Lost to Follow-up, or Leukoplakia During Long-Term Follow-up
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline until death, lost to follow up or study end.
    End point values
    		 Palifermin - LTFU analysis set Placebo - LTFU analysis set
    Number of subjects analysed
    2
    2
    Units: Subjects
    1
    0
    No statistical analyses for this end point

    Secondary: Deaths During Long-Term Follow-up

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    End point title
    		 Deaths During Long-Term Follow-up
    End point description
    End point type
    Secondary
    End point timeframe
    From week 12 until death.
    End point values
    		 Palifermin - LTFU analysis set Placebo - LTFU analysis set
    Number of subjects analysed
    2
    2
    Units: Subjects
    1
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 weeks from first dose of IP for subjects without severe oral mucositis (OM); Up to 15 weeks or resolution for those with severe OM, whichever occurs first
    Adverse event reporting additional description
    20040124 Primary Analysis
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Palifermin
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo Palifermin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
    2 / 3 (66.67%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    C-reactive protein increased
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Red blood cell count increased
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    White blood cell count increased
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Gum neoplasm malignant stage unspecified
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Multi-organ failure
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Infections and infestations
    Peritonitis bacterial
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Palifermin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 2 (100.00%)
    3 / 3 (100.00%)
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    Body temperature increased
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    2
    Vascular disorders
    Lymphoedema
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    Lymphadenitis
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Facial pain
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    Pyrexia
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    3
    Gastrointestinal disorders
    Ascites
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    Dysphagia
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    2 / 2 (100.00%)
    2 / 3 (66.67%)
         occurrences all number
    6
    2
    Oral pain
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    Salivary hypersecretion
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    1 / 2 (50.00%)
    1 / 3 (33.33%)
         occurrences all number
    1
    2
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    Pruritus
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    Skin discolouration
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 2 (50.00%)
    1 / 3 (33.33%)
         occurrences all number
    2
    2
    Infections and infestations
    Bacteriuria
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    Urinary tract infection
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 May 2005
    The protocol was predominately amended to reflect a decrease in dose from from 180 μg/kg to 120 μg/kg.
    15 Dec 2008
    The protocol was updated to reflect the sponsor change from Amgen to Biovitrum.
    15 Jun 2015
    To reduce the long-term safety follow-up from "until death or lost to follow up" to "subjects will be followed for up to 10 years from last subject randomized".

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    25 May 2007
    The study was closed to further enrollment on 25 May 2007 due to administrative changes at the study center and slow enrollment.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Pharmacokinetic, pharmacodynamic, safety and efficacy endpoints were not evaluable due to the limited number of subjects enrolled.
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