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    Clinical Trial Results:
    Efficacy of Olaratumab and Rechallenge with Doxorubicin in anthracycline pretreated, advanced soft tissue sarcoma patients. An exploratory phase-II study - The OlaReDo Phase II Trial

    Summary
    EudraCT number
    		 2018-001124-20
    Trial protocol
    		 DE  
    Global end of trial date
    25 Jun 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Nov 2021
    First version publication date
    04 Nov 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GISG-17
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03698227
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Institut für Klinische Krebsforschung IKF GmbH am Krankenhaus Nordwest
    Sponsor organisation address
    Steinbacher Hohl 2-26, Frankfurt, Germany, 60488
    Public contact
    IKF, Institut für Klinische Krebsforschung IKF GmbH am Krankenhaus Nordwest, 0049 6976014420, olaredo@ikf-khnw.de
    Scientific contact
    IKF, Institut für Klinische Krebsforschung IKF GmbH am Krankenhaus Nordwest, 0049 6976014420, olaredo@ikf-khnw.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
    17 May 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Jun 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Jun 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The present study aimed to evaluate efficacy and safety of olaratumab and doxorubicin combined with the cardioprotective prophylaxis with dexrazoxane in anthracycline pretreated patients. Efficacy was adressed by the progression-free survival rate after 3 months (PFSR3), assessed by applying RECIST 1.1, as primary endpoint and PFS, objective resposne rate, disease control rate and overall survival as secondary endpoints.
    Protection of trial subjects
    The study was conducted in accordance with the ethical principles that have their origins in the Declaration of Helsinki and the trial was approved by an Independent Ethics Committee. The eligibility of a new patient was determined by the local investigator during regular clinical visits. The examinations for the study and the inclusion of the patient were done after detailed written and oral education by use of the informed consent forms and after given written consent of the patient.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Nov 2018
    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: 2
    Worldwide total number of subjects
    2
    EEA total number of subjects
    2
    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)
    2
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Based on the negative results (lack of efficacy) on olaratumab in the ANNOUNCE study (press release dated January 18th, 2019), recruitment of the OlaReDo study was stopped immediately and the so far two enrolled patients were informed by the investigators accordingly.

    Pre-assignment
    Screening details
    		 Study was prematurely stopped after enrollment of 2 patients

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

    Arms
    Arm title
    		 Arm A
    Arm description
    		 patients received 8 cycles (q3w) of olaratumab administered IV (20 mg/kg on day 1 and day 8 of cycle 1 and 15 mg/kg on day 1 and day 8 of cycle 2 to 8) combined with doxorubicin administered IV (75 mg/m2 on day 1 of each cycle for 8 cycles) and dexrazoxane administered IV (at a dose equal to 10 times the doxorubicin dose [mg/m2] on day 1 of each cycle for 8 cycles). According to the study protocol, beginning with cycle 9 Olaratumab maintenance monotherapy should have been performed at 15 mg/kg administered IV on day 1 and day 8 of each subsequent 21 day cycle until documented progressive disease (PD), unacceptable toxicity, or other discontinuation criteria are met. However, due to negative results (lack of efficacy) on olaratumab in the ANNOUNCE study, treatment in the maintenance phase was not performed.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Olaratumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for concentrate for solution for infusion
    Routes of administration
    Infusion , Injection
    Dosage and administration details
    olaratumab was administered IV; 20 mg/kg on day 1 and day 8 of cycle 1 and 15 mg/kg on day 1 and day 8 of cycle 2 to 8

    Investigational medicinal product name
    Doxorubicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    doxorubicin was administered IV; 75 mg/m2 on day 1 of each cycle for 8 cycles

    Investigational medicinal product name
    Dexrazoxane
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for concentrate for solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    dexrazoxane was administered IV at a dose equal to 10 times the doxorubicin dose [mg/m2] on day 1 of each cycle for 8 cycles

    Number of subjects in period 1
    		Arm A
    Started
    2
    Completed
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 2 2
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 2 2
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 1 1
        Male
    		 1 1
    type of tumor
    Units: Subjects
        Chondrosarcoma, upper extremity
    		 1 1
        Synovial sarcoma, trunk
    		 1 1
    ECOG Performance Status
    Units: Subjects
        ECOG 0
    		 1 1
        ECOG 1
    		 1 1
    TNM stage and histopathological grade
    Units: Subjects
        unknown
    		 1 1
        T/N - not documented; M0; G3
    		 1 1
    AJCC stage at study entry
    Units: Subjects
        IV
    		 1 1
        unknown
    		 1 1

    End points

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    End points reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 patients received 8 cycles (q3w) of olaratumab administered IV (20 mg/kg on day 1 and day 8 of cycle 1 and 15 mg/kg on day 1 and day 8 of cycle 2 to 8) combined with doxorubicin administered IV (75 mg/m2 on day 1 of each cycle for 8 cycles) and dexrazoxane administered IV (at a dose equal to 10 times the doxorubicin dose [mg/m2] on day 1 of each cycle for 8 cycles). According to the study protocol, beginning with cycle 9 Olaratumab maintenance monotherapy should have been performed at 15 mg/kg administered IV on day 1 and day 8 of each subsequent 21 day cycle until documented progressive disease (PD), unacceptable toxicity, or other discontinuation criteria are met. However, due to negative results (lack of efficacy) on olaratumab in the ANNOUNCE study, treatment in the maintenance phase was not performed.

    Primary: Progression Free survival after 3 months PFSR3

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    End point title
    		 Progression Free survival after 3 months PFSR3 [1]
    End point description
    Due to the small sample size of only two patients, it was not possible to perform statistical analyses with aggregated data. Thus, only data listings by individual patient have been provided. Out of two enrolled patients, both patients showed progressive-free survival after 3 months of study treatment
    End point type
    Primary
    End point timeframe
    tumor response was determined radiologically prior every second combination treatment cycle (approx. every 6 weeks ± 7 days), during follow up tumor assessment was performed every 3 months ± 3 weeks
    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 sample size of only 2 patients no statistical analyses were possible
    End point values
    		 Arm A
    Number of subjects analysed
    2
    Units: Subjects
        YES
    2
        NO
    0
    No statistical analyses for this end point

    Secondary: Progression-free survival

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    End point title
    		 Progression-free survival
    End point description
    Progression-free survival (PFS) was defined as the time from the first dosing date of any study medication to the date of the first objectively documented tumor progression, or death due to any cause
    End point type
    Secondary
    End point timeframe
    eventual signs of progressive disease and death events were to be assessed and recorded during trial participation (i.e. study drug medication) and the follow-up period which was 6 months
    End point values
    		 Arm A
    Number of subjects analysed
    2
    Units: Subjects
        No Progression
    1
        Progression
    1
    No statistical analyses for this end point

    Secondary: Overall survival

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    End point title
    		 Overall survival
    End point description
    Overall survival (OS) was defined as the time from date of the first dosing date of any study medication to the date of death (due to any cause). Subjects who are alive were censored at the last known alive dates
    End point type
    Secondary
    End point timeframe
    eventual signs of progressive disease and death events were to be assessed and recorded during trial participation (i.e. study drug medication) and the follow-up period which was 6 months
    End point values
    		 Arm A
    Number of subjects analysed
    2
    Units: Subjects
        No Death
    2
        Death
    0
    No statistical analyses for this end point

    Other pre-specified: Best overall response

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    End point title
    		 Best overall response
    End point description
    both patients revealed detectable tumor lesions and valid restaging data for applying RECIST 1.1 criteria. Out of these, 1 patient showed stable disease (SD) until end of study (EOS), the other patient showed stable disease (SD) until the cycle 8 and revealed progressive disease (PD) thereafter
    End point type
    Other pre-specified
    End point timeframe
    tumor response was determined radiologically prior every second combination treatment cycle (approx. every 6 weeks ± 7 days). During follow up (until disease progressin of EOS) tumor assessment was performed every 3 months ± 3 weeks
    End point values
    		 Arm A
    Number of subjects analysed
    2
    Units: Subjects
        Stable disease
    1
        progressive disease
    1
        complete response
    0
        partial response
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were assessed continuously during the study (signature of the informed consent form - up to 30 days after last administration IMP). Thereafter, only SAEs at least possibly related to study treatment were reported
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22
    Reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 patients received 8 cycles (q3w) of olaratumab administered IV (20 mg/kg on day 1 and day 8 of cycle 1 and 15 mg/kg on day 1 and day 8 of cycle 2 to 8) combined with doxorubicin administered IV (75 mg/m2 on day 1 of each cycle for 8 cycles) and dexrazoxane administered IV (at a dose equal to 10 times the doxorubicin dose [mg/m2] on day 1 of each cycle for 8 cycles). According to the study protocol, beginning with cycle 9 Olaratumab maintenance monotherapy should have been performed at 15 mg/kg administered IV on day 1 and day 8 of each subsequent 21 day cycle until documented progressive disease (PD), unacceptable toxicity, or other discontinuation criteria are met. However, due to negative results (lack of efficacy) on olaratumab in the ANNOUNCE study, treatment in the maintenance phase was not performed.

    Serious adverse events
    		 Arm A
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 2 (50.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Arm A
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 2 (100.00%)
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    5
    Platelet count decreased
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    10
    White blood cell count decreased
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    14
    Cardiac disorders
    Cardiac disorder - anthracycline induced cardiomyopathy
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 2 (100.00%)
         occurrences all number
    6
    Chills
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    3
    Edema limbs
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1
    Mucositis oral
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    2
    Nausea
         subjects affected / exposed
    2 / 2 (100.00%)
         occurrences all number
    4
    Vomiting
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1

    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? Yes
    Date
    Interruption
    Restart date
    18 Jan 2019
    Based on the negative results (lack of efficacy) on olaratumab in the ANNOUNCE study (press release dated January 18th, 2019), recruitment of the OlaReDo study was stopped immediately and the two enrolled patients were informed by the investigators accordingly. A halt of the OlaReDo study was notified by the Sponsor to the Competent Authority and Ethics Committee on January 22nd, 2019. Acknowledgement of receipt PEI: 28-Jan-2019; acknowledgement of receipt IRB: 25-Jan-2019
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The OlaReDo study was stopped prematurely with only 2 patients treated according the study protocol. Due to the small sample size of only two patients, statistical analyses were not possible
    For support, Contact us.
    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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