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    Clinical Trial Results:
    Phase I/II study of lenalidomide and Cetuximab in patients with advanced solid tumors

    Summary
    EudraCT number
    		 2009-013423-31
    Trial protocol
    		 AT  
    Global end of trial date
    26 Sep 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Aug 2020
    First version publication date
    21 Aug 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TEXO0309
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University Innsbruck
    Sponsor organisation address
    Christoph-Probst-Platz 1, Innrain 52 A, Innsbruck, Austria, 6020
    Public contact
    Ao.Univ.Prof.Dr. Heinz-Helmut Zwierzina, University Hospital for Internal Medicine I, +43 (0)50 504-36145, heinz-helmut.zwierzina@tirol-kliniken.at
    Scientific contact
    Ao.Univ.Prof.Dr. Heinz-Helmut Zwierzina, University Hospital for Internal Medicine I, +43 (0)50 504-36145, heinz-helmut.zwierzina@tirol-kliniken.at
    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 Sep 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Sep 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Sep 2012
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To determine the maximum tolerated dose (MTD) of lenalidomide administered in combination with cetuximab in patients with solid tumors
    Protection of trial subjects
    Good tolerability and efficacy of lenalidomide (Revlimid®) have been clearly shown in multiple myeloma and in 5q- syndrome (a certain subtype of myelodysplastic syndrome (MDS)). Based on these data, lenalidomide has been approved for clinical application in these disorders and represents a tool for first line therapy.Excellent tolerability and efficacy of cetuximab (Erbitux®) given alone or in combination with various chemotherapeutic drugs have been demonstrated in several phase III trials and have lead to approval of cetuximab for clinical use in various solid tumors. Therefore clinical data of lenalidomide as well as cetuximab monotherapy suggest that no severe unforeseeable side effects are to be expected in this clinical trial using the combination of the drugs.
    Background therapy
    		 Recommended concomitant therapy · Full supportive care is permitted when appropriate, including transfusions of blood and blood products, antibiotics, or antiemetics. · The use of haematopoietic growth factors is permitted, however should not be routinely used as prophylaxis to avoid dose reductions or delays. · Aspirin, warfarin, low-molecular weight heparin, or other anticoagulant therapy is permitted. Prohibited concomitant therapy o Palliative radiation therapy is not permitted
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Aug 2010
    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
    Austria: 1
    Worldwide total number of subjects
    1
    EEA total number of subjects
    1
    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)
    1
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects will be screened within 28 days of study entry. Subjects meeting all inclusion criteria will be enrolled in cohorts of three subjects.

    Pre-assignment
    Screening details
    		 Subjects will be screened within 28 days of study entry.

    Period 1
    Period 1 title
    Treatment period
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Lenalidomide group
    Arm description
    		 Subjects meeting all inclusion criteria will be enrolled in cohorts of three to receive a single, oral dose of lenalidomide administered on Days 1-28 and intravenous (IV) infusions of cetuximab (400 mg/m2 first infusion only, then 250 mg/m2 subsequently) administered on Days 1, 8, 15, and 22 of each 28-day cycle. Prior to Phase 1 Cycle 1, there will be a 21 day lead in treatment period with lenalidomide monotherapy (Days -21 to -1). Combination treatment will start at Day 1. Patients will be hospitalized up to 3 days after Day 1 of Cycle 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lenalidomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects meeting all inclusion criteria will be enrolled in cohorts of three to receive a single, oral dose of lenalidomide administered on Days 1-28 and intravenous (IV) infusions of cetuximab (400 mg/m2 first infusion only, then 250 mg/m2 subsequently) administered on Days 1, 8, 15, and 22 of each 28-day cycle. Prior to Phase 1 Cycle 1, there will be a 21 day lead in treatment period with lenalidomide monotherapy (Days -21 to -1). Combination treatment will start at Day 1.

    Investigational medicinal product name
    Cetuximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects meeting all inclusion criteria will be enrolled in cohorts of three to receive a single, oral dose of lenalidomide administered on Days 1-28 and intravenous (IV) infusions of cetuximab (400 mg/m2 first infusion only, then 250 mg/m2 subsequently) administered on Days 1, 8, 15, and 22 of each 28-day cycle. Prior to Phase 1 Cycle 1, there will be a 21 day lead in treatment period with lenalidomide monotherapy (Days -21 to -1). Combination treatment will start at Day 1.

    Number of subjects in period 1
    		Lenalidomide group
    Started
    1
    Completed
    1
    Period 2
    Period 2 title
    Follow-up period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Lenalidomide group
    Arm description
    		 All study subjects in Phase 1 or Phase 2 who discontinue from the study for any reason other than withdrawal of consent, will enter the Follow-up Period that includes one follow-up visit 28 days after last dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lenalidomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects meeting all inclusion criteria will be enrolled in cohorts of three to receive a single, oral dose of lenalidomide administered on Days 1-28 and intravenous (IV) infusions of cetuximab (400 mg/m2 first infusion only, then 250 mg/m2 subsequently) administered on Days 1, 8, 15, and 22 of each 28-day cycle. Prior to Phase 1 Cycle 1, there will be a 21 day lead in treatment period with lenalidomide monotherapy (Days -21 to -1). Combination treatment will start at Day 1.

    Investigational medicinal product name
    Cetuximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects meeting all inclusion criteria will be enrolled in cohorts of three to receive a single, oral dose of lenalidomide administered on Days 1-28 and intravenous (IV) infusions of cetuximab (400 mg/m2 first infusion only, then 250 mg/m2 subsequently) administered on Days 1, 8, 15, and 22 of each 28-day cycle. Prior to Phase 1 Cycle 1, there will be a 21 day lead in treatment period with lenalidomide monotherapy (Days -21 to -1). Combination treatment will start at Day 1.

    Number of subjects in period 2
    		Lenalidomide group
    Started
    1
    Completed
    0
    Not completed
    1
         Evidence of progrssive disease
    1

    Baseline characteristics

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

    Reporting group values
    		 Treatment period Total
    Number of subjects
    		 1 1
    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)
    		 1 1
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 1 1
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Lenalidomide group
    Reporting group description
    		 Subjects meeting all inclusion criteria will be enrolled in cohorts of three to receive a single, oral dose of lenalidomide administered on Days 1-28 and intravenous (IV) infusions of cetuximab (400 mg/m2 first infusion only, then 250 mg/m2 subsequently) administered on Days 1, 8, 15, and 22 of each 28-day cycle. Prior to Phase 1 Cycle 1, there will be a 21 day lead in treatment period with lenalidomide monotherapy (Days -21 to -1). Combination treatment will start at Day 1. Patients will be hospitalized up to 3 days after Day 1 of Cycle 1.
    Reporting group title
    Lenalidomide group
    Reporting group description
    		 All study subjects in Phase 1 or Phase 2 who discontinue from the study for any reason other than withdrawal of consent, will enter the Follow-up Period that includes one follow-up visit 28 days after last dose.

    Primary: MTD of lenalidomide administered in combination with cetuximab

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    End point title
    		 MTD of lenalidomide administered in combination with cetuximab [1]
    End point description
    Subjects meeting all inclusion criteria will be enrolled in cohorts of three patients to receive a single, oral dose of lenalidomide administered on Days 1-28 and intravenous (IV) infusions of cetuximab (400 mg/m2 first infusion only, then 250 mg/m2 subsequently) administered on Days 1, 8, 15, and 22 of each 28-day cycle. Prior to combination therapy, there will be a 21 day lead in treatment period with lenalidomide monotherapy (Days -21 to -1). Combination treatment will start at Day 1. Cycles will be repeated every 28 days. All subjects will continue on study drug until disease progression, unacceptable toxicity or treatment discontinuation for any other reason. Initial dose of Lenalidomide is 15mg (Dose Level 1).
    End point type
    Primary
    End point timeframe
    Day 1- day 28
    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: As only one subject was included in this trial no statistical anlysis was performed.
    End point values
    		 Lenalidomide group
    Number of subjects analysed
    1
    Units: Milligramm
    number (not applicable)
        Dose Level 1
    15
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12.08.2010- 26.09.2012
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    Lenalidomide group
    Reporting group description
    		 -

    Serious adverse events
    		 Lenalidomide group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Bleeding after liver biopsy
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Urosepsis
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Lenalidomide group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    Injury, poisoning and procedural complications
    Bleeding after liver biopsy
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Renal and urinary disorders
    Urosepsis
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Nov 2009
    Addition zusätzlicher Stärken von Lenalidomidkapseln (10 mg, 15 mg und 20 mg Kapseln) für eine Erleichterung des Patienten bei der Medikationseinahme. Adaption des EudraCT-Formulars, des Prüfplans und der Patienteninformation/ Patienteneinverständniserklärung, sowie Nachreichung der nötigen Unterlagen betreffend der zusätzlichen Prüfpräparate. Lenalidomid is now availaible as capsules in additional concentrations (10 mg, 15 mg und 20 mg Kapseln). All relevant documents have been adapted to this circumstance.
    18 Mar 2010
    Das Protokoll musste geändert werden, da in der Medizinischen Universität Innsbruck ein neues PET-CT-Scan System verwendet wird, welches kein Solo-PET mehr durchführt, sondern nur mehr in Kombination mit einem CT durchgeführt wird. Somit ist eine Änderung der Patientensicherheit gegeben. Solo-PET was replaced with PET-CT Scan System, only combined analysis of PET and CT are possible now.

    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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